`US008396528B2
`
`c12) United States Patent
`Karnath et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 8,396,528 B2
`Mar.12,2013
`
`(54) ANALYTE SENSOR
`
`(75)
`
`Inventors: Apurv Ullas Karnath, San Diego, CA
`(US); Peter C. Simpson, Encinitas, CA
`(US); Mark Brister, Encinitas, CA (US)
`
`(73) Assignee: DEXCOM, Inc., San Diego, CA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 1354 days.
`
`(21) Appl. No.: 12/054,953
`
`(22) Filed:
`
`Mar. 25, 2008
`
`(65)
`
`Prior Publication Data
`
`US 2009/0242425 Al
`
`Oct. 1, 2009
`
`(51)
`
`Int. Cl.
`A61B 5/05
`(2006.01)
`(52) U.S. Cl. ......................... 600/347; 600/345; 600/365
`( 58) Field of Classification Search . ... ... ... ... .. ... 600/34 7,
`600/365
`See application file for complete search history.
`
`(56)
`
`References Cited
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`EP
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`FOREIGN PATENT DOCUMENTS
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`(Continued)
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`OTHER PUBLICATIONS
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`US 7,530,950, 5/2009, Brister et al. (withdrawn).
`
`(Continued)
`
`Primary Examiner - Patricia Mallari
`Assistant Examiner - Michael D' Angelo
`(74) Attorney, Agent, or Firm - Michael Crapenhoft
`
`ABSTRACT
`(57)
`Systems and methods of use for continuous analyte measure(cid:173)
`ment of a host's vascular system are provided. In some
`embodiments, a continuous glucose measurement system
`includes a vascular access device, a sensor and sensor elec(cid:173)
`tronics, the system being configured for insertion into com(cid:173)
`munication with a host's circulatory system.
`
`14 Claims, 34 Drawing Sheets
`
`12b
`
`/2
`
`/8
`
`/8c 26
`
`200\
`
`20
`
`JO
`
`14
`
`26
`
`JO
`
`26
`I
`
`[ ~ 11 I
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2017-01051
`Exhibit 1014
`
`
`
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`US 8,396,528 B2
`Page 2
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`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2017-01051
`Exhibit 1014
`
`
`
`5,281,319 A
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`5,284,570 A
`5,287,753 A
`5,298,022 A
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`5,311,908 A
`5,312,361 A
`5,316,008 A
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`5,326,449 A
`5,330,634 A
`5,331,555 A
`5,335,658 A
`5,337,747 A
`5,342,789 A
`5,345,932 A
`5,352,348 A
`5,352,351 A
`5,354,272 A
`5,354,449 A
`5,356,375 A
`5,356,378 A
`5,368,224 A
`5,368,562 A
`5,372,133 A
`5,372,135 A
`5,372,709 A
`5,376,070 A
`5,378,229 A
`5,380,268 A
`5,380,491 A
`5,380,665 A
`5,384,028 A
`5,390,671 A
`5,391,250 A
`5,411,052 A
`5,411,647 A
`5,411,866 A
`5,417,206 A
`5,421,328 A
`5,423,738 A
`5,423,749 A
`5,425,717 A
`5,429,485 A
`5,429,602 A
`5,431,174 A
`5,437,635 A
`5,445,610 A
`5,462,051 A
`5,462,645 A
`5,476,776 A
`5,482,008 A
`5,482,446 A
`5,482,473 A
`5,484,404 A
`5,486,776 A
`5,494,562 A
`5,497,772 A
`5,502,396 A
`5,505,828 A
`5,507,288 A
`5,509,888 A
`5,512,046 A
`5,512,248 A
`5,513,636 A
`5,514,253 A
`5,515,851 A
`5,527,288 A
`5,531,679 A
`5,531,878 A
`5,549,547 A
`5,549,548 A
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`US 8,396,528 B2
`Page 3
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`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2017-01051
`Exhibit 1014
`
`
`
`US 8,396,528 B2
`Page 4
`
`5,928,155 A
`5,928,182 A
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`6,122,536 A
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`6,144,871 A
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`6,162,201 A
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`6,165,154 A
`6,168,568 Bl
`6,171,276 Bl
`6,175,752 Bl
`6,180,416 Bl
`6,183,437 Bl
`6,191,860 Bl
`6,212,416 Bl
`6,213,739 Bl
`6,233,471 Bl
`6,248,067 Bl
`6,248,077 Bl
`6,248,093 Bl
`6,254,586 Bl
`6,263,222 Bl
`6,268,161 Bl
`6,270,478 Bl
`6,272,364 Bl
`6,275,717 Bl *
`6,280,408 Bl
`6,284,478 Bl
`6,293,925 Bl
`6,294,281 Bl
`6,299,583 Bl
`6,300,002 Bl
`
`7/1999 Eggers et al.
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`10/1999 Heller
`11/1999 Kimball et al.
`11/1999 Sarge et al.
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`1/2000 Van Antwerp et al.
`1/2000 Mika
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`5/2000 Davis
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`6/2000 Adelberg et al.
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`7/2000 Dionne et al.
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`7/2000 Cunningham et al.
`7/2000 Funderburk et al.
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`9/2000 Wong eta!.
`10/2000 Say
`10/2000 Say et al.
`11/2000 Saito et al.
`12/2000 Wickham et al.
`12/2000 Cohen et al.
`12/2000 Moubayed et al.
`12/2000 Gray et al.
`1/2001 Gavriely
`1/2001 Lippe et al.
`1/2001 Say et al.
`1/2001 Kurnik et al.
`2/2001 Walker
`2/2001 Klinger et al.
`4/2001 Ward et al.
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`7/2001 Mann eta!.
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`
`6,302,855 Bl
`6,325,979 Bl
`6,326,160 Bl
`6,329,161 Bl
`6,343,225 Bl
`6,358,225 Bl
`6,360,888 Bl
`6,366,794 Bl
`6,368,141 Bl
`6,368,274 Bl
`6,391,019 Bl
`6,402,703 Bl
`6,403,944 Bl
`6,416,651 Bl
`6,418,332 Bl
`6,424,847 Bl
`6,430,437 Bl
`6,459,917 Bl
`6,461,496 Bl
`6,464,849 Bl
`6,467,480 Bl
`6,474,360 Bl
`6,484,045 Bl
`6,485,449 B2
`6,488,652 Bl
`6,494,879 B2
`6,498,941 Bl
`6,501,976 Bl
`6,510,329 B2
`6,512,939 Bl
`6,514,718 B2
`6,520,326 B2
`6,520,477 B2
`6,520,937 B2
`6,534,711 Bl
`6,536,433 Bl
`6,544,212 B2
`6,546,268 Bl
`6,546,269 Bl
`6,547,839 B2
`6,551,494 Bl*
`6,553,241 B2
`6,554,805 B2
`6,554,822 Bl
`6,558,320 Bl
`6,558,321 Bl
`6,558,347 Bl
`6,558,351 Bl
`6,560,471 Bl
`6,565,509 Bl
`6,565,535 B2
`6,565,807 Bl
`6,569,309 B2
`6,572,545 B2
`6,572,579 Bl
`6,579,257 Bl
`6,585,675 Bl
`6,589,229 Bl
`6,594,514 B2
`6,595,756 B2
`6,595,919 B2
`6,602,221 Bl
`6,605,072 B2
`6,609,071 B2
`6,612,984 Bl
`6,613,379 B2
`6,615,061 Bl
`6,618,603 B2
`6,633,772 B2
`6,641,533 B2
`6,654,625 Bl
`6,656,157 Bl
`6,679,865 B2
`6,684,904 B2
`6,685,668 Bl
`6,689,089 Bl
`6,689,265 B2
`6,695,860 Bl
`6,699,383 B2
`
`10/2001 Lav et al.
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`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2017-01051
`Exhibit 1014
`
`
`
`6,702,249 B2
`6,711,424 Bl
`6,712,796 B2
`6,721,587 B2
`6,723,086 B2
`6,730,200 Bl
`6,736,783 B2
`6,737,158 Bl
`6,743,635 B2
`6,749,587 B2
`6,770,030 Bl
`6,770,067 B2
`6,773,565 B2
`6,780,297 B2
`6,801,041 B2
`6,802,957 B2
`6,804,002 B2
`6,805,693 B2
`6,809,653 Bl
`6,811,548 B2
`6,850,790 B2
`6,858,020 B2
`6,862,465 B2
`6,869,413 B2
`6,887,228 B2
`6,892,085 B2
`6,893,552 Bl
`6,895,263 B2
`6,895,265 B2
`6,902,544 B2
`6,926,691 B2
`6,931,327 B2
`6,932,584 B2
`6,936,006 B2
`6,945,965 B2
`6,948,492 B2
`6,952,604 B2
`6,954,662 B2
`6,960,192 Bl
`6,965,791 Bl
`6,966,325 B2
`6,972,080 Bl
`6,975,893 B2
`6,979,315 B2
`6,989,891 B2
`6,997,921 B2
`6,998,247 B2
`7,003,336 B2
`7,003,341 B2
`7,011,630 B2
`7,022,219 B2
`7,025,743 B2
`7,048,727 Bl
`7,060,059 B2
`7,061,593 B2
`7,063,086 B2
`7,066,884 B2
`7,070,577 Bl
`7,070,580 B2
`7,074,307 B2
`7,078,582 B2
`7,097,775 B2
`7,098,803 B2
`7,100,628 Bl
`7,115,884 Bl
`7,120,483 B2
`7,131,967 B2
`7,134,999 B2
`7,136,689 B2
`7,146,202 B2
`7,150,741 B2
`7,153,265 B2
`7,162,290 Bl
`7,168,597 Bl
`7,169,289 B2
`7,184,810 B2
`7,190,988 B2
`7,207,968 Bl
`7,207,974 B2
`
`3/2004 Ito
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`3/2004 Fentis et al.
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`11/2005 Flaherty et al.
`11/2005 Hitchcock et al.
`11/2005 Erickson
`12/2005 Tomioka et al.
`12/2005 Say et al.
`12/2005 Rogers et al.
`1/2006 Braig et al.
`2/2006 Gray et al.
`2/2006 Monfre et al.
`2/2006 Holker et al.
`2/2006 Say et al.
`3/2006 Desai et al.
`4/2006 Mansouri et al.
`4/2006 Mann eta!.
`5/2006 Moss
`6/2006 Keith et al.
`6/2006 Braig et al.
`6/2006 Shahbazpour et al.
`6/2006 Custer et al.
`7/2006 Haller et al.
`7/2006 Nielsen
`7/2006 Simpson et al.
`7/2006 Stebbings et al.
`8/2006 Greenberg et al.
`8/2006 Mann eta!.
`9/2006 Izenson et al.
`10/2006 Walt et al.
`10/2006 Russell et al.
`11/2006 Gray et al.
`11/2006 Brauker et al.
`11/2006 Shults et al.
`12/2006 Ward et al.
`12/2006 Erickson et al.
`12/2006 Vachon
`1/2007 Levin
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`4/2007 Harcinske
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`
`US 8,396,528 B2
`Page 5
`
`7,211,074 B2
`7,221,970 B2
`7,223,253 B2
`7,228,162 B2
`7,238,165 B2
`7,247,138 B2
`7,254,450 B2
`7,255,690 B2
`7,258,681 B2
`7,266,400 B2
`7,267,665 B2
`7,276,029 B2
`7,288,085 B2
`7,295,867 B2
`7,310,544 B2
`7,311,690 B2
`7,313,425 B2
`7,314,452 B2
`7,315,767 B2
`7,316,662 B2
`7,317,939 B2
`7,318,814 B2
`7,327,273 B2
`7,329,234 B2
`7,334,594 B2
`7,335,179 B2
`7,335,195 B2
`7,338,464 B2
`7,354,420 B2
`7,361,155 B2
`7,364,562 B2
`7,366,566 B2
`7,367,942 B2
`7,381,184 B2
`7,396,353 B2
`7,399,277 B2
`7,424,318 B2
`7,426,408 B2
`7,460,898 B2
`7,467,003 B2
`7,471,972 B2
`7,494,465 B2
`7,497,827 B2
`7,519,408 B2
`2001/0016682 Al
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`2003/0032874 Al
`2003/0036773 Al
`2003/0065254 Al
`2003/0078481 Al
`2003/0097082 Al
`2003/0100821 Al
`2003/0125612 Al*
`2003/0130616 Al*
`2003/0134347 Al
`2003/0138674 Al
`2003/0143746 Al
`2003/0153821 Al
`2003/0187338 Al
`2003/0188427 Al
`2003/0203498 Al
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`
`5/2007 Sansoucy
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`10/2007 Goode et al.
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`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2017-01051
`Exhibit 1014
`
`
`
`US 8,396,528 B2
`Page 6
`
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`2005/0148832 Al*
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`2008/0086042 Al
`2008/0086043 Al
`2008/0086044 Al
`2008/0086273 Al
`2008/0091094 Al
`2008/0091095 Al
`2008/0108942 Al
`2008/0119703 Al
`2008/0119704 Al
`2008/0119706 Al
`
`4/2006 Goldberger et al.
`5/2006 Kellogg et al.
`5/2006 Brunnberg et al.
`7/2006 Brister et al.
`8/2006 Choy et al.
`8/2006 Dobbles et al.
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`8/2006 Peti see et al.
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`8/2006 Shults et al.
`9/2006 Brister et al.
`10/2006 Branker et al.
`10/2006 Rush et al.
`10/2006 Peti see et al.
`10/2006 Brister et al.
`11/2006 Geismar et al.
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`11/2006 Goode et al.
`11/2006 Ward et al.
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`1/2007 Karnath et al.
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`2/2007 Brister et al.
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`8/2007 Curry
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`9/2007 Simpson et al.
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`10/2007 Brister et al.
`10/2007 Simpson et al.
`10/2007 Robinson et al.
`10/2007 Robinson et al.
`10/2007 Robinson et al.
`10/2007 Pesach et al.
`11/2007 Logan
`1/2008 Goode et al.
`2/2008 Roche
`2/2008 Mao et al.
`2/2008 Karnath et al.
`3/2008 Mcgarraugh et al.
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`5/2008 Brister et al.
`5/2008 Brister et al.
`5/2008 Brister et al.
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2017-01051
`Exhibit 1014
`
`
`
`2008/0125751 Al
`2008/0154101 Al
`2008/0183399 Al
`2008/0188731 Al
`2008/0189051 Al
`2008/0194935 Al
`2008/0194936 Al
`2008/0194937 Al
`2008/0194938 Al
`2008/0195967 Al
`2008/0197024 Al
`2008/0200788 Al
`2008/0200789 Al
`2008/0200791 Al
`2008/0208025 Al
`2008/0214915 Al
`2008/0214918 Al
`2008/0242961 Al
`2008/0262469 Al
`2008/027 5313 Al
`2008/0287764 Al
`2008/0287765 Al
`2008/0287766 Al
`2008/0296155 Al
`2008/0306368 Al
`2008/0306434 Al
`2008/0306435 Al
`2008/0306444 Al
`2009/0012379 Al
`2009/0018424 Al
`2009/00367 58 Al
`2009/0043181 Al
`2009/0043182 Al
`2009/0043525 Al
`2009/0043541 Al
`2009/0043542 Al
`2009/0045055 Al
`2009/0062645 Al
`2009/0076356 Al
`2009/0076360 Al
`2009/0076361 Al
`2009/0099436 Al
`2009/0124877 Al
`2009/0124878 Al
`2009/0124879 Al
`2009/0124964 Al
`2009/0131768 Al
`2009/0131769 Al
`2009/0131776 Al
`2009/0131777 Al
`2009/0137886 Al
`2009/0137887 Al
`2009/0143659 Al
`2009/0143660 Al
`2009/0156924 Al
`
`5/2008 Fjield
`6/2008 Jain et al.
`7/2008 Goode et al.
`8/2008 Brister et al.
`8/2008 Goode et al.
`8/2008 Brister et al.
`8/2008 Goode et al.
`8/2008 Goode et al.
`8/2008 Brister et al.
`8/2008 Goode et al.
`8/2008 Simpson et al.
`8/2008 Brister et al.
`8/2008 Brister et al.
`8/2008 Simpson et al.
`8/2008 Shults et al.
`9/2008 Brister et al.
`9/2008 Brister et al.
`10/2008 Brister et al.
`10/2008 Brister et al.
`11/2008 Brister et al.
`11/2008 Rasdal et al.
`11/2008 Rasdal et al.
`11/2008 Rasdal et al.
`12/2008 Shults et al.
`12/2008 Goode et al.
`12/2008 Dobbles et al.
`12/2008 Karnath et al.
`12/2008 Brister et al.
`1/2009 Goode et al.
`1/2009 Karnath et al.
`2/2009 Branker et al.
`2/2009 Branker et al.
`2/2009 Branker et al.
`2/2009 Branker et al.
`2/2009 Br