`Burnett
`
`US 11,224,742 B2
`( 10 ) Patent No .:
`( 45 ) Date of Patent :
`Jan. 18 , 2022
`
`US011224742B2
`
`( 54 )
`
`( * ) Notice :
`
`METHODS AND DEVICES FOR
`PERFORMING ELECTRICAL STIMULATION
`TO TREAT VARIOUS CONDITIONS
`( 71 ) Applicant : EMKinetics , Inc. , San Francisco , CA
`( US )
`( 72 ) Inventor : Daniel R. Burnett , San Francisco , CA
`( US )
`( 73 ) Assignee : EMKinetics , Inc. , San Francisco , CA
`( US )
`Subject to any disclaimer , the term of this
`patent is extended or adjusted under 35
`U.S.C. 154 ( b ) by 145 days .
`( 21 ) Appl . No .: 15 / 665,152
`( 22 ) Filed :
`Jul . 31 , 2017
`( 65 )
`Prior Publication Data
`Dec. 14 , 2017
`US 2017/0354831 A1
`Related U.S. Application Data
`Continuation of application No. 15 / 056,910 , filed on
`Feb. 29 , 2016 , now Pat . No. 9,757,584 , which is a
`( Continued )
`
`( 63 )
`
`( 51 ) Int . Ci .
`A6IN 1/05
`A6IN 1/36
`
`( 52 ) U.S. Ci .
`CPC
`
`( 2006.01 )
`( 2006.01 )
`( Continued )
`A61N 1/0502 ( 2013.01 ) ; A61N 1/0492
`( 2013.01 ) ; A61N 1/36007 ( 2013.01 ) ;
`( Continued )
`( 58 ) Field of Classification Search
`CPC ........ A61N 1/36007 ; A61N 1/36031 ; A61N
`1/0456
`See application file for complete search history .
`
`( 56 )
`
`EP
`GB
`
`References Cited
`U.S. PATENT DOCUMENTS
`2,003,392 A
`2,893,392 A
`
`6/1935 Rucker
`7/1959 Wagner et al .
`( Continued )
`FOREIGN PATENT DOCUMENTS
`
`2493551
`9/2012
`9/1996
`2298370
`( Continued )
`
`OTHER PUBLICATIONS
`Amarenco et al . , " Urodynamic effect of acute transcutaneous pos
`terior tibial nerve stimulation in overactive bladder , " Jun . 2003 ,
`Journal of Urology , vol . 169 , 2210-2215 . ( Year : 2003 ) . *
`( Continued )
`Primary Examiner — Michael W Kahelin
`( 74 ) Attorney , Agent , or Firm — Levine Bagade Han LLP
`-
`( 57 )
`ABSTRACT
`In certain variations , systems and / or methods for electro
`magnetic induction therapy are provided . One or more
`ergonomic or body contoured applicators may be included .
`The applicators include one or more conductive coils con
`figured to generate an electromagnetic or magnetic field
`focused on a target nerve , muscle or other body tissues
`positioned in proximity to the coil . One or more sensors may
`be utilized to detect stimulation and to provide feedback
`about the efficacy of the applied electromagnetic induction
`therapy . A controller may be adjustable to vary a current
`through a coil to adjust the magnetic field focused upon the
`target nerve , muscle or other body tissues based on the
`feedback provide by a sensor or by a patient . In certain
`systems or methods , pulsed magnetic fields may be inter
`mittently applied to a target nerve , muscle or tissue without
`causing habituation .
`13 Claims , 37 Drawing Sheets
`
`136
`
`settembre
`
`*****
`
`The timesta
`
`130
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 1
`
`
`
`US 11,224,742 B2
`Page 2
`
`Related U.S. Application Data
`continuation of application No. 14 / 676,635 , filed on
`Apr. 1 , 2015 , now Pat . No. 9,387,338 , which is a
`continuation of application No. 14 / 085,639 , filed on
`Nov. 20 , 2013 , now Pat . No. 9,002,477 , which is a
`continuation of application No. 13 / 456,016 , filed on
`Apr. 25 , 2012 , now abandoned , which is a continu
`ation of application No. PCT / US2010 / 054167 , filed
`on Oct. 26 , 2010 , said application No. 14 / 085,639 is
`a continuation - in - part of application No. 12 / 508,529 ,
`filed on Jul . 23 , 2009 , now abandoned , which is a
`continuation - in - part of application No. 11 / 866,329 ,
`filed on Oct. 2 , 2007 , now abandoned .
`( 60 ) Provisional application No. 60 / 848,720 , filed on Oct.
`2 , 2006 , provisional application No. 61 / 279,883 , filed
`on Oct. 26 , 2009 .
`( 51 ) Int . Cl .
`A61N 1/40
`A6IN 2/00
`A61N 2/02
`A61N 1/04
`( 52 ) U.S. Ci .
`CPC
`
`( 2006.01 )
`( 2006.01 )
`( 2006.01 )
`( 2006.01 )
`A61N 1/36017 ( 2013.01 ) ; A61N 1/36021
`( 2013.01 ) ; A61N 1/36067 ( 2013.01 ) ; A61N
`1/36071 ( 2013.01 ) ; A61N 1/36075 ( 2013.01 ) ;
`A61N 1/36096 ( 2013.01 ) ; AOIN 1/36107
`( 2013.01 ) ; A61N 1/36139 ( 2013.01 ) ; A61N
`1/40 ( 2013.01 ) ; A61N 2/006 ( 2013.01 ) ; AOIN
`27008 ( 2013.01 ) ; A61N 2/02 ( 2013.01 ) ; A6IN
`1/0456 ( 2013.01 ) ; A61N 1/0484 ( 2013.01 ) ;
`A61N 1/36003 ( 2013.01 )
`References Cited
`U.S. PATENT DOCUMENTS
`3,034,507 A
`3,817,254 A
`3,841,305 A
`4,233,965 A
`4,266,533 A
`4,428,366 A
`4,456,012 A
`4,548,208 A
`4,574,809 A
`4,784,737 A
`4,804,054 A
`4,837,049 A
`4,915,110 A
`4,926,878 A
`4,940,453 A
`4,969,468 A
`4,994,015 A
`5,000,178 A
`5,014,699 A
`5,067,478 A
`5,092,835 A
`5,158,080 A
`5,181,902 A
`5,299,572 A
`5,309,909 A
`5,314,401 A
`5,314,453 A
`5,374,283 A
`5,401,233 A
`5,449,378 A
`5,518,495 A
`5,540,735 A
`5,562,707 A
`5,690,693 A
`
`5/1962 McConnell et al .
`6/1974 Maurer
`10/1974 Hallgren
`11/1980 Fairbanks
`5/1981 Ryaby et al .
`1/1984 Findl et al .
`6/1984 Lattin
`10/1985 Niemi
`3/1986 Talish et al .
`11/1988 Ray et al .
`2/1989 Howson et al .
`6/1989 Byers et al .
`4/1990 Kitov
`5/1990 Snedeker
`7/1990 Cadwell
`11/1990 Byers et al .
`2/1991 Cadwell
`3/1991 Griffith
`5/1991 Pollack et al .
`11/1991 Berlant
`3/1992 Schurig et al .
`10/1992 Kallok
`1/1993 Erickson et al .
`4/1994 Chen et al .
`5/1994 Gadsby et al .
`5/1994 Tepper
`5/1994 Jeutter
`12/1994 Flick
`3/1995 Erickson et al .
`9/1995 Schouenborg
`5/1996 Kolt
`7/1996 Wingrove
`10/1996 Prochazka et al .
`11/1997 Wang et al .
`
`( 56 )
`
`5,715,837 A
`5,725,471 A
`5,749,909 A
`5,766,124 A
`5,792,187 A
`5,792,209 A
`5,833,600 A
`5,857,957 A
`5,978,712 A
`5,984,854 A
`5,995,873 A
`6,009,878 A
`6,024,691 A
`6,029,090 A
`6,032,677 A
`6,066,084 A
`6,086,525 A
`6,088,619 A
`6,123,658 A
`6,132,386 A
`6,143,035 A
`6,155,966 A
`6,179,770 B1
`6,190,893 B1
`6,200,259 B1
`6,213,933 B1
`6,219,575 B1
`6,256,533 B1
`6,261,221 B1
`6,312,612 B1
`6,319,241 B1
`6,334,856 B1
`6,349,233 B1
`6,366,795 B1
`6,379,313 B1
`6,379,324 B1
`6,432,037 B1 *
`6,440,096 B1
`6,443,883 B1
`6,451,240 B1
`6,471,903 B2
`6,473,652 B1
`6,491,620 B1
`6,493,588 B1
`6,500,110 B1
`6,503,231 B1
`6,511,463 B1
`6,527,694 B1
`6,533,949 B1
`6,537,242 B1
`6,553,263 B1
`6,558,361 B1
`6,565,532 B1
`6,582,393 B2
`6,591,124 B2
`6,595,947 B1
`6,603,987 B2
`6,611,707 B1
`6,615,080 B1
`6,622,035 B1
`6,623,457 B1
`6,652,443 B1
`6,652,478 B1
`6,654,636 B1
`6,656,147 B1
`6,663,556 B2
`6,663,820 B2
`6,671,527 B2
`6,678,556 B1
`6,684,106 B2
`6,689,100 B2
`6,690,959 B2
`6,692,444 B2
`6,697,669 B2
`6,701,185 B2
`6,735,474 B1
`6,743,211 B1
`6,767,341 B2
`
`A61B 5/04882
`128/898
`
`2/1998 Chen
`3/1998 Davey et al .
`5/1998 Schroeppel et al .
`6/1998 Polson
`8/1998 Adams
`8/1998 Varner
`11/1998 Young
`1/1999 Lin
`11/1999 Suda et al .
`11/1999 Ishikawa et al .
`11/1999 Rhodes
`1/2000 Weijand et al .
`2/2000 Tepper et al .
`2/2000 Herbst
`3/2000 Blechman et al .
`5/2000 Edrich et al .
`7/2000 Davey et al .
`7/2000 Hein et al .
`9/2000 Schweighofer et al .
`10/2000 Gozani et al .
`11/2000 McDowell
`12/2000 Parker
`1/2001 Mould
`2/2001 Shastri et al .
`3/2001 March
`4/2001 Lin
`4/2001 Nemati
`7/2001 Yuzhakov et al .
`7/2001 Tepper et al .
`11/2001 Sherman et al .
`11/2001 King et al .
`1/2002 Allen et al .
`2/2002 Adams
`4/2002 Bremer et al .
`4/2002 Gozani et al .
`4/2002 Gartstein et al .
`8/2002 Eini
`
`8/2002 Lastovich et al .
`9/2002 Ostrow et al .
`9/2002 Sherman et al .
`10/2002 Sherman et al .
`10/2002 Sarwal et al .
`12/2002 Davey
`12/2002 Malaney et al .
`12/2002 Davey et al .
`1/2003 Prausnitz et al .
`1/2003 Wood et al .
`3/2003 Ishikawa et al .
`3/2003 Yeshurun et al .
`3/2003 Palmer
`4/2003 Meadows et al .
`5/2003 Yeshurun
`5/2003 Yuzhakov et al .
`6/2003 Sage , Jr.
`7/2003 Sherman et al .
`7/2003 Mikszta et al .
`8/2003 Whitson
`8/2003 Prausnitz et al .
`9/2003 Unsworth et al .
`9/2003 Merilainen et al .
`9/2003 Rosenberg
`11/2003 Struppler et al .
`11/2003 Gartstein et al .
`11/2003 Dev et al .
`12/2003 Gertsek et al .
`12/2003 Barker
`12/2003 Arias et al .
`12/2003 Petersson et al .
`1/2004 Nolan et al .
`1/2004 Herbst
`2/2004 Connelly et al .
`2/2004 Thompson
`2/2004 Gozani et al .
`2/2004 Dev et al .
`3/2004 Burnett et al .
`5/2004 Loeb et al .
`6/2004 Prausnitz et al .
`7/2004 Cho
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 2
`
`
`
`US 11,224,742 B2
`Page 3
`
`( 56 )
`
`References Cited
`U.S. PATENT DOCUMENTS
`8/2004 Mechlenburg et al .
`6,770,022 B2
`6,770,480 B1
`8/2004 Canham
`6,782,283 B2
`8/2004 Schmidt et al .
`9/2004 Roy et al .
`6,790,372 B2
`10/2004 Lastovich et al .
`6,808,506 B2
`12/2004 Sage et al .
`6,835,184 B1
`6,866,659 B2
`3/2005 Nemati
`6,881,203 B2
`4/2005 Delmore et al .
`5/2005 Lastovich
`6,899,838 B2
`6,904,614 B2
`6/2005 Yamazaki et al .
`6/2005 Fleming et al .
`6,908,453 B2
`6,926,660 B2
`8/2005 Miller
`6,931,277 B1
`8/2005 Yuzhakov et al .
`9/2005 Geiger
`6,939,311 B2
`6,941,171 B2
`9/2005 Mann et al .
`11/2005 Rosenberg
`6,960,193 B2
`6,962,772 B2
`11/2005 Liu et al .
`12/2005 Zhang et al .
`6,972,013 B1
`6,980,855 B2
`12/2005 Cho
`7,013,179 B2
`3/2006 Carter et al .
`4/2006 Ackley
`7,027,478 B2
`7,032,302 B1
`4/2006 Schmidt et al .
`5/2006 Ozeryansky
`7,045,069 B2
`7,047,070 B2
`5/2006 Wilkinson et al .
`7,048,723 B1
`5/2006 Frazier et al .
`7,079,355 B2
`7/2006 Hsiao et al .
`7,083,592 B2
`8/2006 Lastovich et al .
`7,104,947 B2
`9/2006 Riehl
`7,115,108 B2
`10/2006 Wilkinson et al .
`10/2006 Kronberg
`7,117,034 B2
`7,130,696 B2
`10/2006 Carter et al .
`7,132,054 B1
`11/2006 Kravitz et al .
`7,153,256 B2
`12/2006 Riehl et al .
`7,187,976 B2
`3/2007 Duncan et al .
`7,226,439 B2
`6/2007 Prausnitz et al .
`7,262,068 B2
`8/2007 Roy et al .
`9/2007 Chang et al .
`7,273,474 B2
`7,285,113 B2
`10/2007 Yeshurun
`1/2008 Kwiatkowski et al .
`7,315,758 B2
`7,316,665 B2
`1/2008 Laurent et al .
`1/2008 Riehl et al .
`7,320,664 B2
`7,332,197 B2
`2/2008 Wood et al .
`7,332,339 B2
`2/2008 Canham
`7,344,499 B1
`3/2008 Prausnitz et al .
`5/2008 Myers et al .
`7,367,936 B2
`6/2008 Juliana et al .
`D571,920 S
`7,396,326 B2
`7/2008 Ghiron et al .
`7,410,476 B2
`8/2008 Wilkinson et al .
`7,415,299 B2
`8/2008 Zimmermann et al .
`7,416,541 B2
`8/2008 Yuzhakov et al .
`7,429,333 B2
`9/2008 Chiou et al .
`7,473,244 B2
`1/2009 Frazier et al .
`1/2009 Luharuka et al .
`7,481,337 B2
`7,497,980 B2
`3/2009 Xu et al .
`7,500,911 B2
`3/2009 Johnson et al .
`7,520,848 B2
`4/2009 Schneider et al .
`7,522,061 B2
`4/2009 Rondoni et al .
`7,530,968 B2
`5/2009 Gonnelli
`7,536,226 B2
`5/2009 Williams et al .
`7,556,615 B2
`7/2009 Pettis et al .
`7,556,821 B2
`7/2009 Ameri et al .
`7/2009 Golubovic - Liakopoulos et al .
`7,560,036 B2
`7,570,992 B2
`8/2009 Nolan et al .
`7,572,405 B2
`8/2009 Sherman et al .
`7,574,256 B2
`8/2009 Carter
`7,578,954 B2
`8/2009 Gartstein et al .
`7,582,069 B2
`9/2009 Laurent et al .
`7,588,552 B2
`9/2009 Yeshurun et al .
`7,591,806 B2
`9/2009 Xu
`7,627,938 B2
`12/2009 Kim et al .
`7,628,761 B2
`12/2009 Gozani et al .
`1/2010 Tracey et al .
`7,647,112 B2
`7,648,484 B2
`1/2010 Yeshurun et al .
`7,651,946 B2
`1/2010 Wilke et al .
`7,658,728 B2
`2/2010 Yuzhakov
`
`7,941,201 B2
`8,308,665 B2
`8,430,805 B2
`8,435,166 B2
`8,588,884 B2
`8,660,646 B2
`8,805,510 B2
`8,812,114 B2
`8,818,520 B2
`8,954,153 B2
`9,002,477 B2
`9,005,102 B2
`9,056,194 B2
`9,076,187 B1
`9,245,265 B2
`9,265,941 B2
`9,339,641 B2
`9,387,338 B2
`9,610,459 B2
`9,630,004 B2
`9,757,584 B2
`10,786,669 B2
`2002/0007128 A1
`2002/0028991 Al
`2002/0040233 A1
`2002/0055761 Al
`2002/0082465 A1
`2002/0099323 A1
`2002/0111777 A1
`2002/0133129 A1
`2002/0138116 A1
`2002/0183804 A1
`2662/6183647
`2003/0003968 Al
`2003/0004392 A1
`2003/0028072 Al
`2003/0144625 Al
`2003/0158583 A1
`2003/0158585 A1
`2003/02 16729 A1
`2003/0217754 A1
`2004/0010276 Al
`2004/0015188 A1
`2004/0054393 A1
`2004/0082875 Al
`2004/0092860 A1
`2004/0102819 A1
`2004/0111139 A1
`2004/0122787 Al
`2004/0127939 Al
`2004/0138517 A1
`2004/0146611 A1
`2004/0147964 A1
`2004/0173220 A1
`2004/02 10254 A1
`2004/02 10282 Al
`2004/0237170 A1
`2005/0021104 A1
`2005/0029223 A1
`2005/0033380 A1
`2005/0099290 A1
`2005/0107654 A1
`2005/0143783 A1
`2005/0143789 A1
`2005/0171576 Al
`2005/0203602 A1
`2005/0240230 A1
`2005/0277998 Al
`2005/0283202 Al
`2005/0283204 A1
`2006/0004244 Al
`2006/0015153 Al
`2006/0016452 Al
`2006/0030845 Al
`2006/0047316 A1
`2006/0047326 A1
`2006/0049957 Al
`2006/0052839 Al
`2006/0069415 A1
`
`5/2011 Chiou et al .
`11/2012 Harry et al .
`4/2013 Burnett et al .
`5/2013 Burnett et al .
`11/2013 Hegde et al .
`2/2014 Laing et al .
`8/2014 Chancellor et al .
`8/2014 Van den biggelaar et al .
`8/2014 Laing et al .
`2/2015 Boggs
`4/2015 Burnett
`4/2015 Burnett et al .
`6/2015 Van den biggelaar et al .
`7/2015 Laing et al .
`1/2016 Laing et al .
`2/2016 Van den biggelaar et al .
`5/2016 Rajguru et al .
`7/2016 Burnett
`4/2017 Burnett et al .
`4/2017 Rajguru et al .
`9/2017 Burnett
`9/2020 Rajguru et al .
`1/2002 Ives et al .
`3/2002 Thompson
`4/2002 George et al .
`5/2002 Mann et al .
`6/2002 Bashford et al .
`7/2002 Dev et al .
`8/2002 David
`9/2002 Arias et al .
`9/2002 Bertolucci
`12/2002 Malaney et al .
`12/2002 Gozani et al .
`1/2003 Muraki
`1/2003 Tanner et al .
`2/2003 Fischell et al .
`7/2003 Sherman et al .
`8/2003 Burnett et al .
`8/2003 Burnett
`11/2003 Marchitto et al .
`11/2003 Thomas et al .
`1/2004 Jacobs et al .
`1/2004 Coulter
`3/2004 Stemme et al .
`4/2004 Donoghue et al .
`5/2004 Dev et al .
`5/2004 Zou et al .
`6/2004 McCreery
`6/2004 Avanash et al .
`7/2004 Grey
`7/2004 Osorio et al .
`7/2004 Arias et al .
`7/2004 Nolan et al .
`9/2004 Harry et al .
`10/2004 Burnett et al .
`10/2004 Flock et al .
`12/2004 Yamazaki et al .
`1/2005 Dilorenzo
`2/2005 Yeshurun
`2/2005 Tanner et al .
`5/2005 Govari
`5/2005 Riehl
`6/2005 Boveja et al .
`6/2005 Whitehurst et al .
`8/2005 Williams et al .
`9/2005 Wallace et al .
`10/2005 Preston et al .
`12/2005 Tracey et al .
`12/2005 Gellman
`12/2005 Buhlmann et al .
`1/2006 Phillips et al .
`1/2006 Gliner et al .
`1/2006 Goetz et al .
`2/2006 Leung et al .
`3/2006 Fischell et al .
`3/2006 Wheeler
`3/2006 Surgenor et al .
`3/2006 Kim et al .
`3/2006 Cameron et al .
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 3
`
`
`
`US 11,224,742 B2
`Page 4
`
`A61N 1/36007
`607/41
`
`( 56 )
`
`References Cited
`U.S. PATENT DOCUMENTS
`2006/0084938 Al
`4/2006 Zhang et al .
`2006/0115130 A1
`6/2006 Kozlay
`2006/0122454 Al
`6/2006 Riehl et al .
`2006/0122660 A1
`6/2006 Boveja et al .
`2006/0135844 A1
`6/2006 Alekseyenko
`2006/0155345 A1
`7/2006 Williams et al .
`2006/0161039 Al
`7/2006 Juliana et al .
`2006/0173261 A1
`8/2006 Kall et al .
`2006/0178576 A1
`8/2006 Weber et al .
`2006/0184211 A1
`8/2006 Gaunt et al .
`2006/0199159 Al
`9/2006 Ghiron et al .
`2006/0276702 A1 12/2006 Mcginnis
`2007/0021712 A1
`1/2007 Bernard et al .
`2007/0021803 A1
`1/2007 Deem et al .
`2007/0027353 A1
`2/2007 Ghiron et al .
`2007/0027354 Al
`2/2007 Riehl et al .
`2007/0027355 Al
`2/2007 Riehl et al .
`2007/0142885 A1
`6/2007 Hantash et al .
`2007/0208212 Al
`9/2007 Dilorenzo
`2007/0250162 A1 10/2007 Royalty
`2007/0265489 A1
`11/2007 Fowler et al .
`2007/0265675 A1 * 11/2007 Lund
`2007/0276318 Al
`11/2007 Henley
`2007/0282246 Al 12/2007 Henley
`2008/0004484 Al
`1/2008 Wieraszko et al .
`2008/0033510 A1
`2/2008 Herregraven et al .
`2008/0058874 Al
`3/2008 Westlund et al .
`2008/0063866 A1
`3/2008 Allen et al .
`2008/0065167 Al
`3/2008 Boggs et al .
`2008/0097142 A1
`4/2008 Savage
`2008/0114199 A1
`5/2008 Riehl et al .
`2008/0177128 A1
`7/2008 Riehl et al .
`2008/0177347 Al
`7/2008 Tehrani et al .
`2008/0183070 Al
`7/2008 Unal et al .
`2008/0200748 A1
`8/2008 Testanl et al .
`2008/0224808 A1
`9/2008 Ghiron et al .
`2008/0262287 Al 10/2008 Dussau
`2008/0288035 A1
`11/2008 Gill et al .
`2008/0300655 Al 12/2008 Cholette
`2008/0306325 A1 12/2008 Burnett et al .
`2008/0312725 A1 12/2008 Penner
`2009/0030337 A1
`1/2009 Gozani et al .
`2009/0054950 A1
`2/2009 Stephens
`2009/0073991 A1
`3/2009 Landrum et al .
`2009/0076336 A1
`3/2009 Mazar et al .
`2009/0076340 A1
`3/2009 Libbus et al .
`2009/0076344 A1
`3/2009 Libbus et al .
`2009/0076345 A1
`3/2009 Manicka et al .
`2009/0076363 A1
`3/2009 Bly et al .
`2009/0076364 A1
`3/2009 Libbus et al .
`2009/0076397 A1
`3/2009 Libbus et al .
`2009/0076410 A1
`3/2009 Libbus et al .
`2009/0076559 Al
`3/2009 Libbus et al .
`2009/0076565 A1
`3/2009 Surwit
`2009/0099623 Al
`4/2009 Bentwich
`2009/0118777 A1
`5/2009 Iki et al .
`2009/0132018 A1
`5/2009 DiUbaldi et al .
`2009/0162570 A1
`6/2009 Swenberg et al .
`2009/0171236 Al
`7/2009 Davies
`2009/0198305 A1
`8/2009 Naroditsky et al .
`2009/0227829 A1
`9/2009 Burnett et al .
`2009/0227831 A1
`9/2009 Burnett et al .
`2009/0234179 Al
`9/2009 Burnett et al .
`2009/0234410 A1
`9/2009 Libbus et al .
`2009/0264792 Al 10/2009 Mazar
`2009/0292194 A1 11/2009 Libbus et al .
`2010/0016929 Al
`1/2010 Prochazka
`2010/0022864 Al
`1/2010 Cordero et al .
`2010/0049021 A1
`2/2010 Jina et al .
`2010/0056881 A1
`3/2010 Libbus et al .
`2010/0057147 Al
`3/2010 Fassih et al .
`2010/0057149 Al
`3/2010 Fahey
`2010/0114259 Al
`5/2010 Herregraven et al .
`2010/0119482 Al
`5/2010 Yun et al .
`
`2010/0160712 A1
`2010/0161005 Al
`2010/0168501 Al
`2010/0204538 A1
`2010/0222629 Al
`2010/0222630 A1
`2010/0318009 Al
`2011/0021863 Al
`2011/0144468 A1
`2011/0264163 A1
`2011/0270140 A1
`2011/0295100 Al
`2012/0059432 Al
`2012/0101326 A1
`2012/0302821 A1
`2013/0006322 A1
`2013/0072746 A1
`2013/0072835 Al
`2013/0310909 A1
`2014/0046423 Al
`2014/0148870 A1
`2014/0213842 Al
`2014/0249595 A1
`2014/0288613 A1
`2015/0190648 Al
`2015/0202454 Al
`2015/0227909 Al
`2015/0260471 Al
`2016/0067515 Al
`2016/0067517 Al
`2016/0074671 A1
`2016/0193466 A1
`2018/0050216 A9
`2018/0133472 Al
`2020/0139120 A1
`
`6/2010 Burnett et al .
`6/2010 Wahlgren et al .
`7/2010 Burnett et al .
`8/2010 Burnett et al .
`9/2010 Bumett et al .
`9/2010 Mangrum et al .
`12/2010 Stanley
`1/2011 Burnett et al .
`6/2011 Boggs et al .
`10/2011 Tracey et al .
`11/2011 Israeli
`12/2011 Hegde et al .
`3/2012 Emborg et al .
`4/2012 Simon et al .
`11/2012 Burnett
`1/2013 Tai
`3/2013 Burnett et al .
`3/2013 Harry et al .
`11/2013 Simon et al .
`2/2014 Rajguru et al .
`5/2014 Burnett
`7/2014 Simon et al .
`9/2014 Chancellor et al .
`9/2014 Laing et al .
`7/2015 Fischell et al .
`7/2015 Burnett
`8/2015 Laing et al .
`9/2015 Azhocar
`3/2016 Burnett et al .
`3/2016 Burnett
`3/2016 Bumett et al .
`7/2016 Burnett
`2/2018 Burnett
`5/2018 Tai
`5/2020 Rajguru et al .
`
`FOREIGN PATENT DOCUMENTS
`
`GB
`JP
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`2336544
`2000-254239
`WO 2003/070317
`WO 2006/061688
`WO 2008/032279
`WO 2008/042902
`WO 2008/115426
`WO 2010/047599
`WO 2010/084482
`WO 2011/011748
`WO 2011/011749
`WO 2011/053607
`WO 2011/053661
`WO 2011/150332
`WO 2012/040243
`
`10/1999
`9/2000
`8/2003
`6/2006
`3/2008
`4/2008
`9/2008
`4/2010
`7/2010
`1/2011
`1/2011
`5/2011
`5/2011
`12/2011
`3/2012
`
`OTHER PUBLICATIONS
`“ Tibial Nerve . ” Wikipedia , accessed Oct. 5 , 2020 , https : //en.wikipedia .
`org / wiki / Tibial_nerve . ( Year : 2020 ) . *
`“ Bioflex® RX754P , Single Coated Medical Pressure Sensitive
`Adhesive Tape , ” Technical Data , 2 pages , Dec. 2005 .
`3M Corporation , 3MTM XYZ / Isotropic Electrically Conductive Adhe
`sive Transfer Tape 9707 , 3M Electronics Markets Materials Divi
`sion , 60-5002-0350-4 , 8 pages , 2004 , 3M .
`Aaron , Roy K. et al . , “ Therapeutic Effects of Electromagnetic Fields
`in the Stimulation of Connective Tissue Repair , ” Journal of Cellular
`Biography , 52 ( 1 ) : 42-6 , May 1993 , Wiley - Liss , Inc.
`AmGel Technologies , “ AG603 Sensing Gel , Sensing Gel Designed
`for ECG Applications , ” AG603-3 / 10 , 1 page , 2010 .
`AmGel Technologies , “ AG702 Stimulating Gel , Stimulating Gel
`Designed for carbon film , ” AG702-02 / 06 , 1 page , 2006 .
`AmGel Technologies , “ AG902-184 / 229 Grounding Gel , Grounding
`Gel Designed for Electrosurgical Pads , ” AG902 Series ,
`1 page ,
`2010 .
`AmGel Technologies , “ Release Films , ” 1 Page , Jul . 25 , 2006 ,
`Revision 1 .
`
`>
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 4
`
`
`
`US 11,224,742 B2
`Page 5
`
`>
`
`>
`
`( 56 )
`
`References Cited
`OTHER PUBLICATIONS
`Balmaseda , Marion T. Jr. , et al . , “ Burns in Functional Electric
`Stimulation : Two Case Reports , ” Archives of Physical Medicine and
`Rehabilitation , vol . 38. , pp . 452-453 , Jul . 1987 .
`Biowave Corporation , “ 510 ( k ) Summary for the Biowave Deepwave
`Neuromodulation Pain Therapy Device , ” 6 pages , Appendix B , Dec.
`13 , 2005 .
`Biowave Corporation , “ 510 ( k ) Summary for the Biowave Deepwave
`Neuromodulation Pain Therapy Device , ” 7 pages , Appendix E , Aug.
`15 , 2006 .
`Biowave Corporation , “ Percutaneous Neuromodulation Pain Therapy
`System , ” deepwave , RevB / 080926 , 2008 .
`BlueCross BlueShield of Kansas City , “ Percutaneous Electrical
`Nerve Stimulation ( PENS ) and Percutaneous Neuromodulation
`Therapy ( PNT ) , ” 7 pages , 1988 .
`Bodhale , D.W. et al . , “ Design , fabrication and analysis of silicon
`microneedles for transdermal drug delivery applications , ” Proceed
`ings of the 3rd International Conference on the Development of
`BME in Vietnam , pp . 84-88 , Jan. 11-14 , 2010 .
`Bruce , C.J. et al . , “ Intracardiac Echocardiography , ” European Jour
`nal Echocardiography , vol . 2 , pp . 234-244 , 2001 , The European
`Society of Cardiology .
`Cabodevila , G. et al . ,
`“ An overview on drug delivery usina
`microneedles ” , Institute FEMTO - ST , Dept LPMO , 24 pages , Oct.
`2005 , Workshop Micro Dosing Systems .
`Certified Pulsed Signal Therapy Centers , http : //www.certifiedpst .
`com , 10 pages .
`Choi , S. et al . , “ Microneedle Electrode Array for Electroporation of
`Skin for Gene Therapy , ” 2 pages , 2005 , Controlled Release Society
`32nd Annual Meeting and Exposition Transactions .
`Curley , S. et al . , “ Radiofrequency Ablation of Unresectable Primary
`and Metastatic Hepatic Malignancies , ” Annals of Surgery , vol .
`230 ( 1 ) : 1-8 , 1999 Lippincott Williams & Wilkins , Inc.
`CystoMedix , Inc. ,
`“ Percutaneous Tibial Nerve Stimulation via
`Urgent® PC Neuromodulation System - An Emerging Technology
`for managing Overactive Bladder , ” Business Briefing : Global Sur
`pages , 2004 .
`gery ,
`EBI , L.P. , EBI Bone Healing System , http://www.ebimedical.com/
`products / fracture / bonehealing.html , 5 pages .
`Fallon Community Health Plan , “ Spinal Cord Stimulation , ” 4
`pages , 2006 .
`Grundfest H. et al . , " Stainless Steel Micro - Needle Electrodes Made
`by Electrolytic Pointing , " Review of Scientific Instruments , vol .
`21 ( 4 ) : 2 pages , 1950 , American Institute of Physics .
`Harvinder S. Gil et al . , “ Effect of microneedle design on pain in
`human subjects , ” NIH Public Access Author Manuscript . 24 ( 7 ) :
`585-594 , Sep. 2008 , Clinical Journal of Pain .
`Huber , D.E. et al . , “ Popliteal Vein Compression Under General
`Anaesthesia , ” European Journal of Vascular and Endovascular
`Surgery , vol . 37 , pp . 464-469 , 2009 , Elsevier Ltd.
`Isseroff , Roslyn R. et al . ,
`“ Beta Adrenergic Receptor ( BAR ) Sig
`naling as a novel target for optimizing skin wound healing ” , 5
`pages .
`Jacobson , Jerry I. et al . , “ Low - Amplitude , Extremely Low Fre
`quency Magnetic Fields for the Treatment of Osteoarthritic Knees :
`A Double - Blind Clinical Study , ” Electromagnetic Fields and Human
`Health . Fundamental and Applied Research , pp . 363-364 , Sep.
`17-24 , 2002 , Proceedings of the Third International Conference .
`Jasper , H. et al . , “ Unipolar Electromyograms of Normal and Denervated
`Human Muscle , " pp . 231-244 , Oct. 12 , 1948 , Department of Neu
`rology and Neurosurgery , McGill University , and Montreal Neuro
`logical Institute .
`Kravitz , S. et ai . , Microneedles for In - Situ / In - vivo Electrochemical
`Sensor Applications , 1 page , Sandia National Laboratories .
`Kurtzke , John F. , “ Epidemiology of Spinal Cord injury , ” IV Panamerican
`Congress of Neurology , 18 ( 2-3 ) : 157-90 , 93 , 1975 .
`Lin et al . , “ Magnetic Stimulation of the Bladder in Dogs , ” AAEM
`Annual Meeting 1993 , Muscle & Nerve , Oct. 1993 ( Abstract ) .
`
`Luttge , R. “ Microneedle array electrode for human EEG recording , "
`IFMBE Proceedings 22 , pp . 1246-1249 , 2008 , Springer - Verag Ber
`lin Heidelberg 2009 .
`Maass et al . , “ Contactless Nerve Stimulation and Signal Detection
`by Inductive Transducer , ” Symposium on Application of Magnetism
`in Bioengineering , 1969 .
`McFarlane , J.P. et al . , “ Acute Suppression of Idiopathic Detrusor
`Instability with Magnetic Stimulation of the Sacral Nerve Roots , "
`British Journal of Urology , 80 ( 5 ) : 734-41 , Nov. 1997 .
`Morrison , P.R. et al . “ Radiofrequency Ablation of Thoracic Lesions :
`Part I , Experiments in the Normal Porcine Thorax , ” American
`Journal of Roentgenology , 2005 ; 184 : 375-380 , Feb. 2005 , American
`Roentgen Ray Society .
`NeuroStar TMS Therapy , NeuroStar TMS Therapy® Recipient of
`Medical Design Excellence Award , PRNewswire , 3 pages , Apr.
`2009 .
`Newmark , Inc. , “ Standard Products , Highest Quality Components ,
`Designed & Produced Exclusively for Electrode Manufacturers , "
`Innovation by Design Newmark , 2 pages , www.newmarkine.com/
`std_prods.htm , printed on May 3 , 2010 .
`Noble , J.H. et al . , “ Automatic segmentation of the facial nerve and
`chorda tympani in CT images using spatially dependent features
`values ” , Medical Phsysics , vol . 35 ( 12 ) , pp . 5375-5384 , Dec. 2008 ,
`American Association Physical Medicine .
`Patel , G. et al . , “ Microneedles : The option for painless delivery , "
`www.pharmainfo.net/reviews/microneedles-option-painless
`delivery , 6 pages , printed on Sep. 9 , 2008 .
`6
`Pubmed , U.S. National Library of Medicine National institutes of
`Health , microneedle array electrodePub Med results , www.ncbi .
`nlm.nig.gov/sites/entrez , 2 pages , Search performed on Apr. 22 ,
`2010 .
`Pubmed , U.S. National Library of Medicine National Institutes of
`Health , microneedle electrodePub Med results , www.ncbi.nlm .
`nig.gov/sites/entrez , 7 pages , Search performed on Apr. 22 , 2010 .
`Schaefer , O. et al . , “ CT - guided radiofrequency ablation of a bronchogenic
`carcinoma , ” The British Journal of Radiology , 76 ( 2003 ) , pp .
`268-270 , 2003 , The British Institute of Radiology .
`Shafik , Ahmed , “ Magnetic Stimulation : A Novel Method for Induc
`ing Evacuation of the Neuropathic Rectum and Urinary Bladder in
`a Canine Model , ” Urology 54 ( 2 ) : 368-372 , Aug. 1999 .
`Sheridan . MT . et al . , " Pretreatment apoptosis in carcinoma of the
`cervix correlates with changes in tumour oxygenation during radio
`therapy , ” British Journal of Cancer , 82 ( 6 ) : 1177-1182 , 2000 Cancer
`Research Campaign .
`Sivagangabalan , G. et ai . , “ Comparison of Electroanatomic Contact
`and Noncontact Mapping of Ventricular Scar in a Postinfarct Ovine
`Model With Intramural Needle Electrode Recording and Histologi
`cal Validation , ” Circulation : Arrhythmia and Eiectrophysiology ,
`Journal of the American Heart Association , vol . 1 : 363-369 , 2008 ,
`American Heart Association .
`Solbiati , L. et al . , “ Percutaneous US - guided Radio Frequency Tis
`sue Ablation of Liver Metastases : Treatment and Follow - up in 16
`Patients , ” Radiology , 202 ( 1 ) : 195-203 , 1997 L.S. RSNA .
`The Magstim Company Ltd , “ Air Film Coil , ” Magstim , 4 pages ,
`2007 .
`Thon , W.F. et al . , “ Neuromodulation of voiding dysfunction and
`pelvic pain , ” World Journal of Urology , vol . 9 : pp . 138-141 , 1991 ,
`Springer - Verlag
`Trock , David H. , “ Electromagnetic Fields and Magnets Investiga
`tional Treatment for Musculoskeletal Disorders , ” Rheumatic Dis
`eases Clinics of North America , vol . 26 , No. 1. , Feb. 2000 .
`Trock , David H. , et al . ,
`“ The Effect of Pulsed Electromagnetic
`Fields in the Treatment of Osteoarthritis of the Knee and Cervical
`Spine . Report of Randomized , Double Blind , placebo Controlled
`Trials , ” The Journal of Rheumatology , 1903-1911 , 1994 .
`Tyco Adhesives , “ 2932 Designed Adhesives , ” Specialty Tape Group ,
`1 page .
`van Sonnenberg , E. et al . , “ Radiofrequency Ablation of Thoracic
`Lesions : Part 2 , Initial Clinical Experience — Technical and Multi
`disciplinary Considerations in 30 Patients , ” American Journal of
`Roentgenology , 2005 ; 184 : 381-390 , Feb. 2005 , American Roentgen
`Ray Society .
`
`> >
`
`> >
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 5
`
`
`
`US 11,224,742 B2
`Page 6
`
`( 56 )
`
`References Cited
`OTHER PUBLICATIONS
`“ A Randomized Placebo - Controlled Study To
`Wanich , T. et al ,
`Determine Safety and Efficacy In Terms Of Pain Reduction , Increased
`Range Of Motion , And Reduced Pain Medications , For A Novel
`Percutaneous Neuromodulation Pain Therapy Device ( “ Deepwave? " )
`Following Post - Operative Treatments For Total Knee Replacement
`Procedures , ” American Academy of Orthopaedic Surgeons 2009
`Annual Meeting , 6 pages , Feb. 25-28 , 2008 , Biowave Corporation .
`Warwick , K. et al . , “ The Application of Implant Technology for
`Cybernetic Systems , ” Archives of Neurology , vol . 60 : 1369-1373 ,
`Oct. 2003 , American Medical Association .
`Wijkstrda et al . , “ Selective Stimulation and Blocking of Sacral
`Nerves : Research Setup and Preliminary Results , ” Annual Interna
`tional Conference of the IEEE Engineering in Medicine and Biology
`Society , vol . 13 , No. 2 , 1991 .
`Wilke , N. et al . , “ Fabrication and Characterisation of Microneedle
`Electrode Arrays using Wet Etch Technologies , ” 5 pages , Oct.
`20-21 , 2004 , EMN04 , NMRC , University College .
`Zhao , M. , “ Genetic Analysis of Electric Signal - directed Cell Move
`ment , ” 33 pages , Apr. 8 , 2008 , Modelling Complex Biological
`Systems in the Context of Genomics .
`Zoll Lifecor Corporation , " What is the LifeVest Wearable Defibril
`lator , ” http://www.lifecor.com/about_lifevest/about.asp# , 1 page , printed
`on Jan. 7 , 2011 .
`
`U.S. Appl . No. 12 / 695,087 , filed Jan. 27 , 2010 .
`U.S. Appl . No. 11 / 866,329 , filed Oct. 2 , 2007 .
`U.S. Appl . No. 12 / 508,529 , filed Jul . 23. 2009 .
`U.S. Appl . No. 12 / 469,625 , filed May 20 , 2009 .
`U.S. Appl . No. 12 / 469,358 , filed May 20 , 2009 .
`U.S. Appl . No. 12 / 469,365 , filed May 20 , 2009 .
`U.S. Appl . No. 12 / 606,941 , filed Oct. 27 , 2009 .
`U.S. Appl . No. 12 / 509,304 , filed Jul . 24 , 2009 .
`U.S. Appl . No. 12 / 509,345 , filed Jul . 24 , 2009 .
`U.S. Appl . No. 13 / 457,228 , filed Apr. 26 , 2012 .
`U.S. Appl . No. 14 / 097,568 , filed Dec. 5 , 2013 .
`U.S. Appl . No. 14 / 685,278 , filed Apr. 13. 2015 .
`U.S. Appl . No. 14 / 949,735 , filed Nov. 23 , 2015 .
`U.S. Appl . No. 12 / 509,362 , filed Jul . 24 , 2009 .
`U.S. Appl . No. 15 / 436,538 , filed Feb. 17 , 2017 .
`U.S. Appl . No. 13 / 456,016 , filed Apr. 25 , 2012 .
`U.S. Appl . No. 14 / 085,639 , filed Nov. 20 , 2013 .
`U.S. Appl . No. 14 / 676,635 , filed Apr. 1 , 2015 .
`U.S. Appl . No. 14 / 931,702 , filed Nov. 3 , 2015 .
`U.S. Appl . No. 15 / 056,910 , filed Feb. 29 , 2016 .
`U.S. Appl . No. 12 / 790,619 , filed May 28 , 2010 .
`U.S. Appl . No. 13 / 840,936 , filed Mar. 15 , 2013 .
`U.S. Appl . No. 15 / 084,356 , filed Mar. 29 , 2016 .
`U.S. Appl . No. 15 / 474,875 , filed Mar. 3 , 2017 .
`* cited by examiner
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 6
`
`
`
`U.S. Patent
`
`Jan. 18 , 2022
`
`Sheet 1 of 37
`
`US 11,224,742 B2
`
`22
`
`28
`
`20
`
`32
`
`38 .
`
`42
`
`40
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 7
`
`
`
`U.S. Patent
`
`Jan. 18 , 2022
`
`Sheet 2 of 37
`
`US 11,224,742 B2
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 8
`
`
`
`U.S. Patent
`
`Jan. 18,2022
`
`Sheet 3 of 37
`
`US 11,224,742 B2
`
`30 52
`
`numre
`
`*** H .. * . * . -
`
`60
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 9
`
`
`
`U.S. Patent
`
`Jan. 18 , 2022
`
`Sheet 4 of 37
`
`US 11,224,742 B2
`
`ber
`
`8
`
`22
`
`mo
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 10
`
`
`
`U.S. Patent
`
`Jan. 18 , 2022
`
`Sheet 5 of 37
`
`US 11,224,742 B2
`
`FIG . 7B
`
`FIG . 7A
`
`FIG . 70
`
`1
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 11
`
`
`
`U.S. Patent
`
`Jan. 18 , 2022
`
`Sheet 6 of 37
`
`US 11,224,742 B2
`
`98
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 12
`
`
`
`U.S. Patent
`
`Jan 18 , 2022
`
`Sheet 7 of 37
`
`US 11,224,742 B2
`
`? GO
`
`2. *
`
`gelang
`
`T
`
`? ?
`
`S
`
`? S -
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 13
`
`
`
`U.S. Patent
`
`Jan. 18 , 2022
`
`Sheet 8 of 37
`
`US 11,224,742 B2
`
`potentiam
`
`
`
`opstadt 7166
`
`126
`
`In the season
`
`30
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 14
`
`
`
`U.S. Patent
`
`Jan. 18 , 2022
`
`Sheet 9 of 37
`
`US 11,224,742 B2
`
`om het
`
`SS
`
`FIG . 12
`
`Petitioner - Avation Medical, Inc.
`Ex. 1040, p. 15
`
`
`
`U.S. Patent
`
`Jan. 18 , 2022
`
`Sheet 10 of 37
`
`US 11,224,742 B2
`
`228
`
`229
`
`230
`
`E
`
`FIG . 13
`
`236
`
`235
`
`23