throbber
(12) United States Patent
`Say et al.
`
`USOO6175752B1
`(10) Patent No.:
`US 6,175,752 B1
`(45) Date of Patent:
`Jan. 16, 2001
`
`(54) ANALYTE MONITORING DEVICE AND
`METHODS OF USE
`(75) Inventors: James Say, Alameda; Michael F.
`Tomasco, Cupertino, both of CA (US);
`Adam Heller, Austin, TX (US); Yoram
`Gal, Kibbutz Yagur (IL); Behrad Aria,
`Alameda, CA (US); Ephraim Heller,
`Oakland, CA (US); Philip John
`Plante, Sunnyvale, CA (US); Mark S.
`Vreeke, Alameda, CA (US); Keith A.
`Esta, it S.E.edric
`s
`s
`(73) Assignee: Therasense, Inc., Alameda, CA (US)
`(*) Notice:
`Under 35 U.S.C. 154(b), the term of this
`patent shall be extended for 0 days.
`(21) Appl. No.: 09/070,677
`1-1.
`(22) Filed:
`Apr. 30, 1998
`
`(51) Int. Cl." .................................................... A61B 5/05
`(52) U.S. Cl. ........................... 600/345; 600/365; 128/903
`(58) Field of Search ..................................... 600/300-301,
`600/346, 306–309, 345-365, 372, 385-390;
`604/174–180; 128/897-898, 903, 904, 920
`O
`References Cited
`U.S. PATENT DOCUMENTS
`
`(56)
`
`6/1989 Dormer et al. .
`Re. 32.947
`7/1966 Ross, Jr..
`3.260,656
`4/1972 Klein.
`3.653.841
`3/1973 Lilly, Jr. et al..
`3,719,564
`12/1973 Oswin et al..
`3,776,832
`9/1974 Aisenberg et al..
`3,837,339
`12/1975 Allen et al..
`3,926,760
`8/1976 Kalman.
`3,972,320
`9/1976 Newman.
`3,979,274
`3.2. taki
`2.
`405 5. 175 E7 i? N. et al. .
`4,059,406
`11/1977 Fleet.
`4,076,596
`2/1978 Connery et al. .
`
`
`
`4,098,574
`4,100,048
`
`7/1978 Dappen.
`7/1978 Pompei et al. .
`(List continued on next page.)
`FOREIGN PATENT DOCUMENTS
`227 029 A3
`9/1985 (DD).
`29 03 216
`8/1979 (DE).
`(List continued on next page.)
`OTHER PUBLICATIONS
`Abruna, H. D. et al., “Rectifying Interfaces Using
`Two-Layer, Films of Electrochemically Polymerized
`Vinylpyridine and Vinylbipyridine Complexes of Ruthe
`nium and Iron on Electrodes,” J. Am. Chem. Soc.,
`103(1):1-5 (Jan. 14, 1981).
`(List continued on next page.)
`Primary Examiner-Cary O’Connor
`ASSistant Examiner Michael Astorino
`(74) Attorney, Agent, or Firm Merchant & Gould P.C.
`(57)
`ABSTRACT
`An analyte monitor includes a Sensor, a Sensor control unit,
`and a display unit. The Sensor has, for example, a Substrate,
`a recessed channel formed in the Substrate, and conductive
`material disposed in the recessed channel to form a working
`electrode. The Sensor control unit typically has a housing
`adapted for placement on Skin and is adapted to receive a
`portion of an electrochemical Sensor. The Sensor control unit
`also includes two or more conductive contacts disposed on
`the housing and configured for coupling to two or more
`- 0
`contact pads on the Sensor. A transmitter is disposed in the
`housing and coupled to the plurality of conductive contacts
`for transmitting data obtained using the Sensor. The display
`unit has a receiver for receiving data transmitted by the
`transmitter of the Sensor control unit and a display coupled
`to the receiver for displaying an indication of a level of an
`analyte. The analyte monitor may also be part of a drug
`delivery system to alter the level of the analyte based on the
`data obtained using the Sensor.
`
`94 Claims, 26 Drawing Sheets
`
`SMALL RECEIVER
`AND
`DISPLAY UNIT
`
`48
`
`LARGE
`RECEIVER
`AND DISPLAY
`UNIT
`
`SENSOR
`CONTROL
`UNIT
`
`SENSOR
`
`IPR2020-00910
`Garmin, et al. EX1006 Page 1
`
`

`

`US 6,175,752 B1
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`4,151,845
`4,168.205
`4,172,770
`4,178,916
`4,206,755
`4,224,125
`4,240,438
`4,247.297
`4,340.458
`4,352,960
`4,356,074
`4,365,637
`4,366,033
`4,375,399
`4,384,586
`4,390,621
`4,401,122
`4,404,066
`4,418,148
`4,427,770
`4,431,004
`4,436,094
`4,440,175
`4,450.842
`4,458,686
`4,461,691
`4,469,110
`4,477,314
`4,484.987
`4,522,690
`4,524,114
`4,526,661
`4,534,356
`4,538,616
`4,543,955
`4,545.382
`4,552,840
`4,560,534
`4,571,292
`4,573.994
`4,581,336
`4,595,011
`4,619,754
`4,627,445
`4,627,908
`4,633,878
`4,637,403
`4,650,547
`4,654,197
`4,655,880
`4,655,885
`4,671,288
`4,679,562
`4,680,268
`4,682,602
`4,684,537
`4,685,463
`4,703,756
`4,711.245
`4,717.673
`4,721,601
`4,721,677
`4,726,378
`4,726,716
`4,757,022
`4,758,323
`4,759,371
`4,759,828
`4,764,416
`4,776.944
`
`5/1979
`9/1979
`10/1979
`12/1979
`6/1980
`9/1980
`12/1980
`1/1981
`7/1982
`10/1982
`10/1982
`12/1982
`12/1982
`3/1983
`5/1983
`6/1983
`8/1983
`9/1983
`11/1983
`1/1984
`2/1984
`3/1984
`4/1984
`5/1984
`7/1984
`7/1984
`9/1984
`10/1984
`11/1984
`6/1985
`6/1985
`7/1985
`8/1985
`9/1985
`10/1985
`10/1985
`11/1985
`12/1985
`2/1986
`3/1986
`4/1986
`6/1986
`10/1986
`12/1986
`12/1986
`1/1987
`1/1987
`3/1987
`3/1987
`4/1987
`4/1987
`6/1987
`7/1987
`7/1987
`7/1987
`8/1987
`8/1987
`11/1987
`12/1987
`1/1988
`1/1988
`1/1988
`2/1988
`2/1988
`7/1988
`7/1988
`7/1988
`7/1988
`8/1988
`10/1988
`
`Clemens.
`Danninger et al. .
`Semersky et al. .
`McNamara.
`Klein.
`Nakamura et al. .
`Updike et al..
`Berti et al. .
`Lerner et al. .
`Dormer et al. .
`Johnson.
`Johnson.
`Richter et al. .
`Havas et al. .
`Christiansen.
`Bauer.
`Clark, Jr. .
`Johnson.
`Oberhardt.
`Chen et al. .
`Bessman et al. .
`Cerami.
`Wilkins.
`Zick et al. .
`Clark, Jr. .
`Frank.
`Slarna.
`Richter et al. .
`Gough.
`Venkatsetty.
`Samuels et al. .
`Steckhan et al. .
`Papadakis.
`Rogoff.
`Schroeppel.
`Higgins et al. .
`Riffer.
`Kung et al. .
`Liu et al. .
`Fischell et al. .
`Malloy et al..
`Phillips.
`Niki et al. .
`Garcia et al. .
`Miller.
`Bombardieri.
`Garcia et al. .
`Gough.
`Lilja et al. .
`Liu .
`Hill et al. .
`Gough.
`Luksha.
`Clark, Jr. .
`Prohaska.
`Graetzel et al. .
`Williams.
`Gough et al. .
`Higgins et al. .
`Wrighton et al..
`Wrighton et al..
`Clark, Jr. .
`Kaplan.
`McGuire .
`Shults et al. .
`Davis et al. .
`Franetzki.
`Young et al. .
`Ueyama et al. .
`Janata et al. .
`
`4,781,798
`4,784,736
`4,795.707
`4,796,634
`4,805,624
`4,813,424
`4,815,469
`4.820,399
`4,822,337
`4,830.959
`4,832,797
`4,840,893
`4,848,351
`4,871,351
`4,871,440
`4,874,500
`4,890,620
`4,894,137
`4,897,162
`4,897,173
`4909,908
`4,911,794
`4,917,800
`4.919,141
`4.919,767
`4923,586
`4,927,516
`4,934,369
`4,935,105
`4,935,345
`4,938.860
`4,944.299
`4.950,378
`4,953,552 *
`4.954,129
`4.969,468
`4970,145
`4,974,929
`4,986,271
`4,994,167
`5,001,054
`5,050,612
`5,058,592
`5,070,535
`5,082.550
`5,082,786
`5,089,112
`5,095,904
`5,101,814
`5,108,564
`5,109,850
`5,120,420
`5,126,034
`5,133,856
`5,135,003
`5,141,868
`5,161,532
`5,165,407
`5,174,291
`5,190,041
`5,192,416
`5,198.367
`5,202.261
`5,205,920
`5,208,154
`5,209,229
`5,217,595
`5,229.282
`5,250,439
`5,262,035
`5,262,305
`
`11/1988
`11/1988
`1/1989
`1/1989
`2/1989
`3/1989
`3/1989
`4/1989
`4/1989
`5/1989
`5/1989
`6/1989
`7/1989
`10/1989
`10/1989
`10/1989
`1/1990
`1/1990
`1/1990
`1/1990
`3/1990
`3/1990
`4/1990
`4/1990
`4/1990
`5/1990
`5/1990
`6/1990
`6/1990
`6/1990
`7/1990
`7/1990
`8/1990
`9/1990
`9/1990
`11/1990
`11/1990
`12/1990
`1/1991
`2/1991
`3/1991
`9/1991
`10/1991
`12/1991
`1/1992
`1/1992
`2/1992
`3/1992
`4/1992
`4/1992
`5/1992
`6/1992
`6/1992
`7/1992
`8/1992
`8/1992
`11/1992
`11/1992
`12/1992
`3/1993
`3/1993
`3/1993
`4/1993
`4/1993
`5/1993
`5/1993
`6/1993
`7/1993
`10/1993
`11/1993
`11/1993
`
`Gough .
`Lonsdale et al. .
`Niiyama et al. .
`Huntsman et al. .
`Yao et al. .
`Wilkins.
`Cohen et al. .
`Senda et al. .
`Newhouse et al. .
`McNeil et al. .
`Vadgama et al. .
`Hill et al. .
`Finch.
`Feingold.
`Nagata et al..
`Madou et al. .
`Gough .
`Takizawa et al. .
`Lewandowski et al. .
`Nankai et al. .
`Ross et al. .
`Parce et al. .
`Lonsdale et al. .
`Zier et al. .
`Vadgama et al. .
`Katayama et al. .
`Yamaguchi et al. .
`Maxwell.
`Churchouse.
`Guilbeau et al. .
`Wogoman.
`Silvian.
`Nagara.
`DeMarzo ............................. 600/300
`Giuliani et al. .
`Byers et al. .
`Bennetto et al. .
`Curry.
`Wilkins.
`Shults et al. .
`Wagner.
`Matsumura.
`Whisler.
`Hochmair et al. .
`Rishpon et al. .
`Nakamoto.
`Skotheim et al. .
`Seligman et al. .
`Palti.
`Szuminsky et al. .
`Blanco et al. .
`Nankai et al. .
`Carter et al. .
`Yamaguchi et al. .
`Souma.
`Shanks et al. .
`Joseph .
`Wilson et al. .
`Schoonen et al. .
`Palti.
`Wang et al..
`Aizawa et al. .
`Musho et al. .
`Oyama et al..
`Weaver et al. .
`Gilli.
`Smith et al. .
`Yoshioka et al. .
`Musho et al. .
`Gregg et al. .
`Heller et al. .
`
`IPR2020-00910
`Garmin, et al. EX1006 Page 2
`
`

`

`US 6,175,752 B1
`Page 3
`
`11/1993 Yoshioka et al. .
`5,264,103
`11/1993 Gregg et al. .
`5,264,104
`11/1993 McAleer et al. .
`5,264,106
`12/1993 Wong.
`5,271,815
`1/1994 Anderson et al. .
`5,279,294
`2/1994 Hoenes et al. .
`5,286,362
`2/1994 Yacynych et al. .
`5,286.364
`2/1994 Pollmann et al. .
`5,288,636
`3/1994 Tadros et al. .
`5,293.546
`6/1994 Davidson.
`5,320,098
`6/1994 Gregg et al..
`5,320,725
`6/1994 Allen et al. .......................... 600/372
`5,322,063
`8/1994 Neftel.
`5,337.747
`10/1994 Young et al..
`5,352,348
`10/1994 Young et al..
`5,356,348
`10/1994 Heller et al. .
`5,356,786
`11/1994 Palti.
`5,368,028
`12/1994 Hogen Esch.
`5,372,133
`12/1994 Kaneko et al. .
`5,376,251
`1/1995 Gratzel et al. .
`5,378,628
`2/1995 Khan.
`5,387.327
`2/1995 Lord et al. .
`5,390,671
`2/1995 Cheney, II et al..
`5,391,250
`3/1995 Saurer et al. .
`5,395,504
`3/1995 Beaubiah ............................. 600/309
`5,400,782
`5/1995 Johnson et al. .
`5,411,647
`8/1995 Diebold et al. .
`5,437,999
`11/1995 Khan.
`5,469,846
`2/1996 Suni et al. ........................... 128/903
`5,491,474
`2/1996 Maley et al..
`5,494,562
`3/1996 Uenoyama et al..
`5,496,453
`3/1996 Schulman et al. .
`5,497,772
`7/1996 Vadgama et al..
`5,531,878
`8/1996. Mann et al. .
`5,545,191
`10/1996 Faupel et al..
`5,560,357
`5,562,713 * 10/1996 Silvian ................................. 128/903
`5,565,085
`10/1996 Ikeda et al. .
`5,567,302
`10/1996 Song et al. .
`5,568,806
`10/1996 Cheney, II et al..
`5,569,186
`10/1996 Lord et al. .
`5,582,184
`12/1996 Erickson et al. .
`5,582,697
`12/1996 Ikeda et al. .
`5,582,698
`12/1996 Flaherty et al..
`5,586,553
`12/1996 Halili et al. .
`5,589,326
`12/1996 Deng et al..
`5,593,852
`1/1997 Heller et al. .
`5,596,150
`1/1997 Arndt et al. .
`5,617,851
`4/1997 Lipkovker.
`5,628,890
`5/1997 Carter et al. .
`5,651.869
`7/1997 Yoshioka et al. .
`5,660,163
`8/1997 Schulman et al. .
`5,670,031
`9/1997 Hintsche et al. .
`5,680.858
`10/1997 Hansen et al. .
`5,682,233
`10/1997 Brinda.
`5,695,623
`12/1997 Michel et al. .
`5,708.247
`1/1998 McAleer et al. .
`5,711,297
`1/1998 Iliff et al. ............................. 600/300
`5,711,861
`1/1998 Ward et al. .......................... 600/365
`5,711,862
`1/1998 Sakoda et al. .
`5,741,211
`4/1998 Renirie et al. .
`5,771,001
`6/1998 Cobb .................................... 128/903
`5,791,344
`8/1998 Schulman et al. ................... 600/300
`5,800,420
`9/1998 Gross et al. ...................... 604/890.1
`5,807.375
`9/1998 Gross et al. .
`5,820,551 * 10/1998 Hill et al. ............................. 600/365
`5,820,622 * 10/1998 Gross et al. ...................... 604/890.1
`5,822,715
`10/1998 Worthington et al. .
`5,827,184 * 10/1998 Netherly et al. ..................... 600/385
`5,840,020
`11/1998 Heinonen et al. .
`5,842,983 * 12/1998 Abel et al. ........................... 600/372
`5,885,211 * 3/1999 Eppstein et al. ..................... 600/365
`
`
`
`5,954,685 * 9/1999 Tierny .................................. 600/386
`5,971,922
`10/1999 Arita et al. ........................... 600/365
`
`FOREIGN PATENT DOCUMENTS
`
`10/1990 (DE).
`3934299
`4/1980 (EP).
`O O1O 375 A1
`4/1981 (EP).
`O O26 995 A1
`3/1982 (EP).
`O 048 090 A2
`5/1983 (EP)
`O O78 636A1
`O O96 228A1 12/1983 (EP).
`O 125 139 A2 11/1984 (EP).
`O 127958 A2 12/1984 (EP).
`O 136 362 A1
`4/1985 (EP).
`O 17O 375 A2
`2/1986 (EP).
`O 177743 A2
`4/1986 (EP).
`O 080304 B1
`5/1986 (EP).
`O 184909 A2
`6/1986 (EP).
`O 206 218 A2 12/1986 (EP).
`O 230 472 A1
`8/1987 (EP).
`O 241 309 A3 10/1987 (EP).
`O 245 O73 A2 11/1987 (EP).
`O 278 647 A2
`8/1988 (EP).
`O 359 831 A1
`3/1990 (EP).
`O 368 290A1 10/1990 (EP).
`390 390A1 10/1990 (EP).
`O 400 918 A1 12/1990 (EP).
`O 453 283 A1 10/1991 (EP).
`O 470 290A1
`2/1992 (EP).
`O 127958 B2
`3/1992 (EP).
`O 255 291 B1
`6/1992 (EP).
`13941.71
`5/1975 (GB).
`1599241
`9/1981 (GB).
`2 073891
`10/1981 (GB).
`2 154 003
`2/1988 (GB).
`2 204 408
`11/1988 (GB).
`2 254 436
`10/1992 (GB).
`54-41.191
`4/1979 (JP).
`55-10581
`1/1980 (JP).
`55-10583
`1/1980 (JP).
`55-10584
`1/1980 (JP).
`55-12406
`1/1980 (JP).
`56-163447
`12/1981 (JP).
`57-70448
`4/1982 (JP).
`60-173457
`9/1985 (JP).
`60-173458
`9/1985 (JP).
`60-173459
`9/1985 (JP).
`61-900SO
`5/1986 (JP).
`62-85855
`4/1987 (JP).
`62-114747
`5/1987 (JP).
`63-58149
`3/1988 (JP).
`63-128252
`5/1988 (JP).
`63-139246
`6/1988 (JP).
`63-294.799
`12/1988 (JP).
`63-317757
`12/1988 (JP).
`63-317758
`12/1988 (JP).
`1-114746
`5/1989 (JP).
`1-114747
`5/1989 (JP).
`1-124060
`5/1989 (JP).
`1-134244
`5/1989 (JP).
`1-156658
`6/1989 (JP).
`2-62958
`3/1990 (JP).
`2-12O655
`5/1990 (JP).
`2-2871.45
`11/1990 (JP).
`2-310457
`12/1990 (JP).
`3-26956
`2/1991 (JP).
`3-28752
`2/1991 (JP).
`3-2O2764
`9/1991 (JP).
`5-72171
`3/1993 (JP).
`5-196595
`8/1993 (JP).
`6-1900SO
`7/1994 (JP).
`7-55757
`3/1995 (JP).
`
`IPR2020-00910
`Garmin, et al. EX1006 Page 3
`
`

`

`US 6,175,752 B1
`Page 4
`
`7-72585
`8-285814
`8-285815
`9-21778
`9-101280
`9-285.459
`10-170471
`1281988 A1
`WO 89/O5119
`WO 89/08713
`WO 90/O5300
`WO 90/O5910
`WO 91/O1680
`WO 91/04704
`WO 91/15993
`WO 92/13271
`WO 94/20602
`WO 94/27140
`WO 96/30431
`WO 96/35370
`WO 97/02847
`WO 97/19344
`WO 97/42882
`WO 97/42883
`WO 97/42886
`WO 97/42888
`WO 97/43962
`
`3/1995 (JP).
`11/1996 (JP).
`11/1996 (JP).
`1/1997 (JP).
`4/1997 (JP).
`11/1997 (JP).
`6/1998 (JP).
`1/1987 (SU).
`11/1985 (WO).
`9/1989 (WO).
`5/1990 (WO).
`5/1990 (WO).
`2/1991 (WO).
`4/1991 (WO).
`10/1991 (WO).
`8/1992 (WO).
`9/1994 (WO).
`11/1994 (WO).
`10/1996 (WO).
`11/1996 (WO).
`1/1997 (WO).
`5/1997 (WO).
`11/1997 (WO).
`11/1997 (WO).
`11/1997 (WO).
`11/1997 (WO).
`11/1997 (WO).
`OTHER PUBLICATIONS
`Albery, W.J. et al., “Amperometric enzyme electrodes. Part
`II. Conducting Salts as electrode materials for the oxidation
`of glucose oxidase,” J. Electroanal. Chem. Interfacial Elec
`trochem., 194(2) (1 page-Abstract only) (1985).
`Albery, W. J. et al., “Amperometric Enzyme Electrodes,”
`Phil. Trans. R Soc. Lond B316:107–119 (1987).
`Alcock, S.J. et al., “Continuous Analyte Monitoring to Aid
`Clinical Practice.” IEEE Engineering in Medicine and Biol
`ogy, 319-325 (1994).
`Anderson, L. B. et al., “Thin-Layer Electrochemistry:
`Steady-State Methods of Studying Rate Processes,” J. Elec
`troanal. Chem., 10:295-395 (1965).
`Bartlett, P. N. et al., “Covalent Binding of Electron Relays
`to Glucose Oxidation,” J. Chem. Soc. Chem. Commun.,
`1603–1604 (1987).
`Bartlett, P. N. et al., “Modification of glucose oxidase by
`tetrathiafulvalene,” J. Chem. Soc., Chem. Commun., 16 (1
`page-Abstract only) (1990).
`Bartlett, P. N. et al., “Strategies for the Development of
`Amperometric Enzyme Electrodes,” BioSensors, 3:359-379
`(1987/88).
`Bindra, D.S. et al., “Design and in Vitro Studies of a
`Needle-Type Glucose Sensor for Subcutaneous Monitor
`ing", Anal. Chem, 63(17): 1692–1696 (Sep. 1, 1991).
`Bobbioni-Harsch, E. et al., “Lifespan of subcutaneous glu
`coSe Sensors and their performances during dynamic gly
`caemia changes in rats,” J. Biomed. Eng. 15:457-463
`(1993).
`Brandt J. et al., "Covalent attachment of proteins to polysac
`charide carriers by means of benzoquinone, Biochim. Bio
`phys. Acta, 386(1) (1 page Abstract only) (1975).
`Brownlee, M. et al., “A Glucose-Controlled Insulin-Deliv
`ery System: Semisynthetic Insulin Bound to Lectin”, Sci
`ence, 206(4423): 1190–1191 (Dec. 7, 1979).
`Cass, A.E.G. et al., “Ferricinum Ion AS An Electron Accep
`tor for Oxido-Reductases,” J. Electroanal. Chem.,
`190:117-127 (1985).
`
`Cass, A.E.G. et al., “Ferrocene-Mediated Enzyme Electrode
`for Amperometric Determination of Glucose', Anal. Chem.,
`56(4):667-671 (Apr. 1984).
`Castner, J. F. et al., “Mass Transport and Reaction Kinetic
`Parameters Determined Electrochemically for Immobilized
`Glucose Oxidase,” Biochemistry, 23(10):2203-2210 (1984).
`Claremont, D.J. et al., “BioSensors for Continuous. In Vivo
`Glucose Monitoring”, IEEE Engineering in Medicine and
`Biology Society 10th Annual International Conference, New
`Orleans, Louisiana, 3 pgs. (Nov. 4–7, 1988).
`Clark L.C. et al., “Differential Anodic Enzyme Polarography
`for the Measurement of Glucose”, Oxygen Transport to
`Tissue. Instrumentation, Methods, and Physiology, 127-132
`(1973).
`Clark, L.C., Jr. et al., “Electrode Systems for Continuous
`Monitoring in Cardiovascular Surgery,” Annals New York
`Academy of Sciences, pp. 29-45 (1962).
`Clark, L.C. et al., “Long-term Stability of Electroenzymatic
`Glucose Sensors Implanted in Mice,” Trans. Am. Soc. Artif
`Intern. Organs, XXXIV:259-265 (1988).
`Clarke, W. L., et al., “Evaluating Clinical Accuracy of
`Systems for Self-Monitoring of Blood Glucose,” Diabetes
`Care, 10(5):622-628 (Sep.-Oct. 1987).
`Csóregi, E. et al., “Design, Characterization, and One-Point
`in Vivo Calibration of a Subcutaneously Implanted Glucose
`Electrode,” Anal. Chem. 66(19):3131-3138 (Oct. 1, 1994).
`Csóregi, E. et al., “Design and Optimization of a Selective
`Subcutaneously Implantable Glucose Electrode Based on
`“Wired” Glucose Oxidase,” Anal. Chem. 67(7): 1240–1244
`(Apr. 1, 1995).
`Csóregi, E. et al., “On-Line Glucose Monitoring by Using
`Microdialysis Sampling and Amperometric Detection Based
`on “Wired” Glucose Oxidase in Carbon Paste,” Mikrochim.
`Acta. 121:31-40 (1995).
`Davis, G., “Electrochemical Techniques for the Develop
`ment of Amperometric Biosensors”, BioSensors, 1:161-178
`(1985).
`Degani, Y. et al., “Direct Electrical Communication between
`Chemically Modified Enzymes and Metal Electrodes. 1.
`Electron Transfer from Glucose Oxidase to Metal Electrodes
`via Electron Relays, Bound Covalently to the Enzyme,” J.
`Phys. Chem. 91(6):1285–1289 (1987).
`Degani, Y. et al., “Direct Electrical Communication between
`Chemically Modified Enzymes and Metal Electrodes. 2.
`Methods for Bonding Electron-Transfer Relays to Glucose
`Oxidase and D-Amino-Acid Oxidase,” J. Am. Chem. Soc.,
`110(8):2615–2620 (1988).
`Degani, Y. et al., “Electrical Communication between Redox
`Centers of Glucose Oxidase and Electrodes via Electrostati
`cally and Covalently Bound Redox Polymers,” J. Am. Chem.
`Soc., 111:2357-2358 (1989).
`Denisevich, P. et al., “Unidirectional Current Flow and
`Charge State Trapping at Redox Polymer Interfaces on
`Bilayer Electrodes: Principles, Experimental Demonstra
`tion, and Theory,” J. Am. Chem. Soc., 103(16):4727-4737
`(1981).
`Dicks, J. M., “Ferrocene modified polypyrrole with immo
`bilised glucose oxidase and its application in amperometric
`glucose microbiosensors,” Ann. Biol. clin., 47:607-619
`(1989).
`Engstrom, R.C., “Electrochemical Pretreatment of Glassy
`Carbon Electrodes”, Anal. Chem, 54(13):2310-2314 (Nov.
`1982).
`
`IPR2020-00910
`Garmin, et al. EX1006 Page 4
`
`

`

`US 6,175,752 B1
`Page 5
`
`EngStrom, R.C. et al., “Characterization of Electrochemi
`cally Pretreated Glassy Carbon Electrodes', Anal. Chem.,
`56(2): 136–141 (Feb. 1984).
`Ellis, C. D., “Selectivity and Directed Charge Transfer
`through an Electroactive Metallopolymer Film,” J. Am.
`Chem. Soc., 103(25):7480–7483 (1981).
`Feldman, B.J. et al., “Electron Transfer Kinetics at Redox
`Polymer/Solution Interfaces Using Microelectrodes and
`Twin Electrode Thin Layer Cells”, J. Electroanal. Chem.,
`194(1):63–81 (Oct. 10, 1985).
`Fischer, H. et al., “Intramolecular Electron Transfer Medi
`ated by 4,4'-Bipyridine and Related Bridging Groups', J.
`Am. Chem. Soc., 98(18):5512-5517 (Sep. 1, 1976).
`Foulds, N.C. et al., “Enzyme Entrapment in Electrically
`Conducting Polymers,” J. Chem. Soc., Faraday Trans 1.,
`82:1259–1264 (1986).
`Foulds, N.C. et al., “Immobilization of Glucose Oxidase in
`Ferrocene-Modified Pyrrole Polymers,” Anal. Chem.,
`60(22):2473–2478 (Nov. 15, 1988).
`Frew, J.E. et al., “Electron-Transfer Biosensors”, Phil.
`Trans. R Soc. Lond, B316:95-106 (1987).
`Gorton, L. et al., “Selective detection in flow analysis based
`on the combination of immobilized enzymes and chemically
`modified
`electrodes,”
`Analytica
`Chimica
`Acta.,
`250:203–248 (1991).
`Gregg, B. A. et al., “CroSS-Linked Redox Gels Containing
`Glucose Oxidase for Amperometric BioSensor Applica
`tions.” Analytical Chemistry, 62(3):258-263 (Feb. 1, 1990).
`Gregg, B. A. et al., “Redox Polymer Films Containing
`Enzymes. 1. A Redox-Conducting Epoxy Cement: Synthe
`sis, Characterization, and Electrocatalytic Oxidation of Hyd
`roquinone,” J. Phys. Chem., 95(15):5970-5975 (1991).
`Hale, PD et al., “A New Class of Amperometric Biosensor
`Incorporating a Polymeric Electron-Transfer Mediator,” J.
`Am. Chem. Soc., 111 (9):3482-3484 (1989).
`Harrison, D.J. et al., “Characterization of Perfluorosulfonic
`Acid Polymer Coated Enzyme Electrodes and a Miniatur
`ized Integrated Potentiostat for Glucose Analysis in Whole
`Blood”, Anal. Chem, 60(19):2002–2007 (Oct. 1, 1988).
`Hawkridge, F. M. et al., “Indirect Coulometric Titration of
`Biological Electron Transport Components.” Analytical
`Chemistry, 45(7):1021–1027 (Jun. 1973).
`Heller, A., “Amperometric biosensors based on three-di
`mensional hydrogel-forming epoxy networks, SensOrS and
`Actuators B. 13–14:180–183 (1993).
`Heller, A., “Electrical Connection of Enzyme Redox Centers
`to Electrodes,” J. Phys. Chem., 96(9):3579–3587 (1992).
`Heller, A., “Electrical Wiring of Redox Enzymes,” Acc.
`Chem. Res., 23(5):129-134 (1990).
`Ianniello, R.M. et al. “Immobilized Enzyme Chemically
`Modified Electrode as an Amperometric Sensor”, Anal.
`Chem, 53(13):2090–2095 (Nov. 1981).
`Ianniello, R.M. et al., “Differential Pulse Voltammetric
`Study of Direct Electron Transfer in Glucose Oxidase
`Chemically Modified Graphite Electrodes”, Anal. Chem.,
`54(7):1098-1101 (Jun. 1981).
`Ikeda, T. et al., “Glucose oxidase-immobilized benzoquino
`ne-carbon paste electrode as a glucose Sensor,” Agric. Biol.
`Chem., 49(2) (1 page-Abstract only) (1985).
`Ikeda, T. et al., “Kinetics of Outer-Sphere Electron Trans
`fers Between Metal Complexes in Solutions and Polymeric
`Films on Modified Electrodes', J. Am. Chem. Soc.,
`103(25):7422–7425 (Dec. 16, 1981).
`
`Johnson, J. M. et al., “Potential-Dependent Enzymatic
`Activity in an Enzyme Thin-Layer Cell,” Anal. Chem.
`54:1377–1383 (1982).
`Johnson, K. W., “Reproducible Electrodeposition of Bio
`molecules for the Fabrication of Miniature Electroenzymatic
`Biosensors’, Sensors and Actuators B Chemical, B5:85-89
`(1991).
`Jonsson, G. et al., “An Amperometric Glucose Sensor Made
`by Modification of a Graphite Electrode Surface With
`Immobilized Glucose Oxidase and Adsorbed Mediator',
`Biosensors, 1:355-368 (1985).
`Josowicz, M. et al., “Electrochemical Pretreatment of Thin
`Film Platinum Electrodes', J.
`Elecrochem. Soc.,
`135(1):112–115 (Jan. 1988).
`Katakis, I. et al., “Electrostatic Control of the Electron
`Transfer Enabling Binding of Recombinant Glucose Oxi
`dase and Redox Polyelectrolytes,” J. Am. Chem. Soc.,
`116(8):3617-3618 (1994).
`Katakis, I. et al., “L-O-Glycerophosphate and L-Lactate
`Electrodes Based on the Electrochemical “Wiring” of Oxi
`dases,” Analytical Chemistry, 64(9): 1008-1013 (May 1,
`1992).
`Kenausis, G. et al., “Wiring of glucose oxidase and lactate
`oxidase within a hydrogel made with poly(Vinyl pyridine)
`complexed
`with
`Os(4,4'-dimethoxy-2,2'-bipyridine)C1''",” J. Chem.
`Soc., Faraday Trans., 90(20):4131–4136 (1996).
`Koudelka, M. et al., “In-Vivo Behaviour of Hypodermically
`Implanted Microfabricated Glucose Sensors”, BioSensors &
`Bioelectronics, 6(1):31-36 (1991).
`KulyS, J. et al., “Mediatorless peroxidase electrode and
`preparation of bienzyme Sensors, Bioelectrochemistry and
`Bioenergetics, 24:305-311 (1990).
`Lager, W. et al., “Implantable Electrocatalytic Glucose Sen
`sor.” Horm. Metab. Res., 26:526-530 (Nov. 1994).
`Lindner, E. et al. "Flexible (Kapton-Based) Microsensor
`Arrays of High Stability for Cardiovascular Applications”, J.
`Chem. Soc, Faraday Trans., 89(2):361-367 (Jan. 21, 1993).
`Maidan, R. et al., “Elimination of Electrooxidizable Inter
`ferant-Produced Currents in Amperometric Biosensors.”
`Analytical Chemistry, 64(23):2889–2896 (Dec. 1, 1992).
`Mastrototaro, J.J. et al., “An Electroenzymatic Glucose
`Sensor Fabricated on a Flexible Substrate’, Sensors and
`Biosensors B Chemical, B5:139-144 (1991).
`McNeil, C. J. et al., “Thermostable Reduced Nicotinamide
`Adenine Dinucleotide Oxidase: Application to Amperomet
`ric Enzyme Assay,” Anal. Chem., 61(1):25-29 (Jan. 1,
`1989).
`Miyawaki, O. et al., “Electrochemical and Glucose Oxidase
`Coenzyme Activity of Flavin Adenine Dinucleotide
`Covalently Attached to Glassy Carbon at the Adenine Amino
`Group”, Biochimica et Biophysica Acta, 838:60-68 (1985).
`Moatti-Sirat, D. et al., “Evaluating in vitro and in vivo the
`inteference of ascorbate and acetaminophen on glucose
`detection by a needle-type glucose Sensor, BioSensOrS &
`Bioelectronics, 7(5):345-352 (1992).
`Moatti-Sirat, D. et al., “Reduction of acetaminophen inter
`ference in glucose Sensors by a composite Nafion mem
`brane: demonstration in rats and man,” Diabetologia, 37(6)
`(1 page-Abstract only) (Jun. 1994).
`Moatti-Sirat, D. et al., “Towards continuous glucose moni
`toring: in Vivo evaluation of a miniaturized glucose Sensor
`implanted for Several days in rat Subcutaneous tissue,”
`Diabetologia, 35(3) (1 page-Abstract only) (Mar. 1992).
`
`IPR2020-00910
`Garmin, et al. EX1006 Page 5
`
`

`

`US 6,175,752 B1
`Page 6
`
`Nagy, G. et al., “A New Type of Enzyme Electrode: The
`Ascorbic Acid Eliminator Electrode,” Life Sciences,
`31(23):2611–2616 (1982).
`Nakamura, S. et al., “Effect of Periodate Oxidation on the
`Structure and Properties of Glucose Oxidase,” Biochinica et
`Biophysica Acta., 445:294-308 (1976).
`NaraZimhan, K. et al., “p-Benzoquinone activation of metal
`oxide electrodes for attachment of enzymes, Enzyme
`Microb. Technol, 7(6) (1 page-Abstract only) (1985).
`Ohara, T. J. et al., “Glucose Electrodes Based on
`Cross-Linked
`Os(bpy)C1'''
`Complexed
`Poly(1-vinylimadazole) Films,” Analytical Chemistry,
`65(23):3512–3516 (Dec. 1, 1993).
`Ohara, T. J., “Osmium Bipyridyl Redox Polymers Used in
`Enzyme Electrodes.” Platinum Metals Re:, 39(2):54–62
`(Apr. 1995).
`Ohara, T.J. et al., “Wired” Enzyme Electrodes for Ampero
`metric Determination of Glucose or Lactate in the Presence
`of Interfering
`Substances,”
`Analytical
`Chemistry,
`66(15):2451–2457 (Aug. 1, 1994).
`Olievier, C. N. et al., “In Vivo Measurement of Carbon
`Dioxide Tension with a Miniature Electrode, Pflugers Arch.
`373:269-272 (1978).
`Paddock, R. et al., “Electrocatalytic reduction of hydrogen
`peroxide Via direct electron transfer from pyrolytic graphite
`electrodes to irreversibly adsorbed cytochrome c peroxi
`dase,” J. Electroanal. Chem., 260:487–494 (1989).
`Paleschi, G. et al., “A Study of Interferences in Glucose
`Measurements in Blood by Hydrogen Peroxide Based Glu
`cose Probes", Anal. Biochem, 159:114-121 (1986).
`Pankramov, I. et al., “Sol-gel derived renewable-surface
`biosensors,” Journal of Electroanalytical Chemistry,
`393:35-41 (1995).
`Pathak, C. P. et al., “Rapid Photopolymerization of Immu
`noprotective Gels in Contact with Cells and Tissue,” J. Am.
`Chem. Soc., 114(21):8311-83.12 (1992).
`Pickup, J., “Developing glucose Sensors for in Vivo use,”
`Tibtech, 11:285–289 (Jul 1993).
`Pickup, J. C. et al., “In Vivo molecular Sensing in diabetes
`mellitus: an implantable glucose Sensor with direct electron
`transfer.” Diabetologia, 32(3):213–217 (1989).
`Pickup, J. et al., “Potentially-implantable, amperometric
`glucose Sensors with mediated electron transfer: improving
`the operating stability,” BioSensors, 4(2) (1 page-Abstract
`only) (1989).
`Pishko, M.V. et al., “Amperometric Glucose Microelec
`trodes Prepared Through Immobilization of Glucose Oxi
`dase in Redox Hydrogels”, Anal. Chem, 63(20):2268-2272
`(Oct. 15, 1991).
`Poitout, V. et al., “A glucose monitoring System for on line
`estimation in man of blood glucose concentration using a
`miniaturized glucose Sensor implanted in the Subcutaneous
`tissue and a wearable control unit,” Diabetologia, 36(7) (1
`page-Abstract only) (Jul 1993).
`Poitout, V. et al., “Calibration in dogs of a subcutaneous
`miniaturized glucose Sensor using a glucose meter for blood
`glucose determination,
`BioSensOrS & Bioelectronics,
`7:587-592 (1992).
`Poitout, V. et al., “In vitro and in vivo evaluation in dogs of
`a miniaturized glucose sensor,” ASAIO Transactions, 37(3)
`(1 page-Abstract only) (Jul.-Sep. 1991).
`Pollak, A. et al., “Enzyme immobilization by Condensation
`Copolymerization into Cross-Linked Polyacrylamide Gels,”
`J. Am. Chem. Soc., 102(20):6324–6336 (1980).
`
`Reach, G. et al., “Can Continuous Glucose Monitoring Be
`Used for the Treatment of Diabetes?” Analytical Chemistry,
`64(6):381–386 (Mar. 15, 1992).
`Rebrin, K. et al., “Automated Feedback Control of Subcu
`taneous Glucose Concentration in Diabetic Dogs”, Diabe
`tologia, 32(8):573–576 (Aug. 1989).
`Sakakida, M. et al., “Ferrocene-mediate needle-type glu
`coSe Sensor covered with newly designed biocompatible
`membrane,” Sensors and Actuators B, 13-14:319-322
`(1993).
`Samuels, G. J. et al., “An Electrode-Supported Oxidation
`Catalyst Based on Ruthenium (IV). pH “Encapsulation” in
`a Polymer Film,” J. Am. Chem. Soc., 103(2):307-312
`(1981).
`Sasso, S.V. et al., “Electropolymerized 1,2-Diaminobenzene
`as a Means to Prevent Interferences and Fouling and to
`Stabilize Immobilized Enzyme in Electrochemical Biosen
`sors”, Anal. Chem., 62(11): 1111-1117 (Jun. 1, 1990).
`Scheller, F. et al., “Enzyme electrodes and their application,”
`Phil. Trans. R Soc. Lond, B 316:85–94 (1987).
`Schmehl, R.H. et al., “The Effect of Redox Site Concentra
`tion on the Rate of Mediated Oxidation of Solution Sub
`strates by a Redox Copolymer Film”, J. Electroanal. Chem.,
`152:97–109 (Aug. 25, 1983).
`Shichiri, M. et al., “Glycaemic Control in Pancrearetomized
`Dogs with a Wearable Artificial Endocrine Pancreas”, Dia
`betologia, 24(3):179–184 (Mar. 1983).
`Sirtampalam, G. et al., “Surface-Modified Electrochemical
`Detector for Liquid Chromatography”, Anal. Chem.,
`55(9):1608–1610 (Aug. 1983).
`Soegijoko, S. et al., Horm. Metabl. Res., Suppl. Ser: 12 (1
`page-Abstract only) (1982).
`Sprules, S. D. et al., “Evaluation of a New Disposable
`Screen-Printed Sensor Strip for the Measurement of NADH
`and Its Modification to Produce a Lactate Biosensor
`Employing
`Microliter
`Volumes,”
`Electroanalysis,
`8(6):539–543 (1996).
`Sternberg, F. et al., “Calibration Problems of Subcutaneous
`Glucosensors when Applied "In-Situ” in Man,” Horm.
`metabl. Res. 26:524–525 (1994).
`Sternberg, R. et al., “Covalent Enzyme Coupling on Cellu
`lose Acetate Membranes for Glucose Sensor Development,”
`Analytical Chemistry, 60(24):2781-2786 (Dec. 15, 1988).
`Sternberg, R. et al., “Study and Development of Multilayer
`Needle-type Enzyme-based Glucose Microsensors,” Bio
`sensors, 4:27-40 (1988).
`Suckane, M., “Immobilization of glucose isomerase,”
`Zeitschrift fur Allgemeine Mikrobiologie, 22(8):565-576
`(1982).
`Tajima, S. et al., “Simultaneous Determination of Glucose
`and 1.5-Anydroglucitol”, Chemical Abstracts, 111(25):394
`111:228556g (Dec. 18, 1989).
`Tarasevich, M.R. “Bioelectrocatalysis”, Comprehensive
`Treasige of Electrochemistry, 10 (Ch. 4):231-295 (1985).
`Tatsuma, T. et al., “Enzyme Monolayer- and Bilayer-Modi
`fied Tin Oxide Electrodes for the Determination of Hydro
`gen
`Peroxide
`and
`Glucose.”
`Anal.
`Chem.,
`61(21):2352–2355 (Nov. 1, 1989).
`Taylor, C. et al., “Wiring of glucose oxidase within a
`hydrogel made with polyvinyl imidazole complexed with
`(Os-4,4'-dimethoxy-2,2'-bipyridine)C1''",” Journal of
`Electroanalytical Chemistry, 396:511–515 (1995).
`
`IPR2020-00910
`Garmin, et al. EX1006 Page 6
`
`

`

`US 6,175,752 B1
`Page 7
`
`Trojanowicz, M. et al., “Enzyme Entrapped Polypyrrole
`Modified Electrode for Flow-Injection Determination of
`Glucose,” Biosensors & Bioelectronics, 5:149-156 (1990).
`Turner, A.P.F. et al., “Diabetes Mellitus: Biosensors for
`Research and Management”, BioSensors, 1:85-115 (1985).
`Turner, R.F.B. et al., “A Biocompatible Enzyme Electrode
`for Continuous in vivo Glucose Monitoring in Whole
`Blood.” Sensors and Actuators, B1(1-6):561-564 (Jan.
`1990).
`Tuzhi, P. et al., “Constant Potential Pretreatment of Carbon
`Fiber Electrodes for In vivo Electrochemistry”, Analytical
`Letters, 24(6):935–945 (1991).
`Umaha, M., “Protein-Modified Electrochemically Active
`Biomaterial Surface,” U.S. Army Research Office Report, (12
`pages) (Dec. 1988).
`Urban, G. et al., “Miniaturized Thin-Film Biosensors. Using
`Covalently Immobilized Glucose Oxidase”, BioSensors &
`Bioelectro

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket