`
`1111111111111111111111111111111q41111)111111111111111i
`
`(12) United States Patent
`Rajguru et al.
`
`(10) Patent No.: US 11,844,943 B2
`(45) Date of Patent:
`*Dec. 19, 2023
`
`METHOD AND APPARATUS FOR
`TRANSDERMAL STIMULATION OVER THE
`PALMAR AND PLANTAR SURFACES
`
`Applicant: EMKinetics, Inc., San Francisco, CA
`(US)
`
`Inventors: Amit Rajguru, Lafayette, CA (US);
`Daniel R. Burnett, San Francisco, CA
`(US); Alexander Vergara, San
`Francisco, CA (US); Michael Hemati,
`San Francisco, CA (US)
`
`Assignee: EMKinetics, Inc., San Francisco, CA
`(US)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 191 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21) Appl. No.: 17/568,276
`
`(22) Filed:
`
`Jan. 4, 2022
`
`(65)
`
`Prior Publication Data
`
`US 2022/0126095 Al
`
`Apr. 28, 2022
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 16/732,706, filed on
`Jan. 2, 2020, now Pat. No. 11,247,053, which is a
`(Continued)
`
`(51) Int. Cl.
`A61N 1/00
`A61N 2/00
`
`(2006.01)
`(2006.01)
`(Continued)
`
`(52) U.S. Cl.
`CPC
`
` A61N 1/36021 (2013.01); A61B 5/388
`(2021.01); A61N 1/0456 (2013.01);
`(Continued)
`
`(58) Field of Classification Search
`CPC .. A61N 1/0456; A61N 1/0484; A61N 1/0492;
`A61N 1/0502; A61N 1/36003;
`(Continued)
`
`(56)
`
`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
`
`CN
`EP
`
`3/1994
`1083402
`5/2012
`2456512
`(Continued)
`
`OTHER PUBLICATIONS
`
`"Bioflex® RX754P, Single Coated Medical Pressure Sensitive
`Adhesive Tape," Technical Data, 2 pages, Dec. 2005.
`(Continued)
`
`Jon Eric C Morales
`Primary Examiner
`(74) Attorney, Agent, or Firm Levine Bagade Han LLP
`
`(57)
`
`ABSTRACT
`
`The disclosure describes devices and methods for providing
`transdermal electrical stimulation therapy to a subject
`including positioning a stimulator electrode over a glabrous
`skin surface overlying a palm of the subject and delivering
`electrical stimulation via a pulse generator transdermally
`through the glabrous skin surface and to a target nerve or
`tissue within the hand to stimulate the target nerve or tissue
`within the hand so that pain felt by the subject is mitigated.
`The pulses generated during the electrical stimulation
`therapy may include pulses of two different magnitudes.
`
`39 Claims, 72 Drawing Sheets
`
`vti
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 1
`
`

`

`US 11,844,943 B2
`Page 2
`
`Related U.S. Application Data
`
`continuation of application No. 15/474,875, filed on
`Mar. 30, 2017, now Pat. No. 10,786,669, which is a
`continuation of application No. 15/084,356, filed on
`Mar. 29, 2016, now Pat. No. 9,630,004, which is a
`continuation of application No. 13/840,936, filed on
`Mar. 15, 2013, now Pat. No. 9,339,641, which is a
`continuation-in-part of application No. PCT/US2011/
`052415, filed on Sep. 20, 2011, said application No.
`15/474,875 is a continuation-in-part of application
`No. 12/508,529, filed on Jul. 23, 2009, which is a
`continuation-in-part of application No. 11/866,329,
`filed on Oct. 2, 2007, now abandoned.
`
`(60) Provisional application No. 62/350,610, filed on Jun.
`15, 2016, provisional application No. 61/403,680,
`filed on Sep. 20, 2010, provisional application No.
`60/848,720, filed on Oct. 2, 2006.
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2021.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`(51) Int. Cl.
`A61N 1/34
`A61N 1/04
`A61N 1/36
`A61N 2/02
`A61B 5/388
`A61N 1/378
`A61B 5/00
`A61N 1/05
`(52) U.S. Cl
` A61N 1/36007 (2013.01); A61N 1/36057
`CPC
`(2013.01); A61N 2/02 (2013.01); A61B 5/4047
`(2013.01); A61N 1/0551 (2013.01); A61N
`1/36017 (2013.01); A61N 1/3787 (2013.01);
`A61N 2/004 (2013.01)
`(58) Field of Classification Search
`CPC
`A61N 1/36007; A61N 1/36017; A61N
`1/36021; A61N 1/36067; A61N 1/36071;
`A61N 1/36075; A61N 1/36096; A61N
`1/36107; A61N 1/36139; A61N 1/40;
`A61N 2/006; A61N 2/008; A61N 2/02
`See application file for complete search history.
`
`(56)
`
`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
`
`5/1962 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.
`
`5,309,909 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
`5,715,837 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
`6,272,383 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
`6,453,204 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
`
`Gadsby et al.
`5/1994
`Tepper
`5/1994
`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.
`2/1998 Chen
`3/1998 Davey et al.
`5/1998 Schroeppel et al.
`6/1998 Poison
`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.
`8/2001
`Grey 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 et al.
`8/2002 Lastovich et al.
`9/2002 Ostrow et al.
`9/2002 Sherman et al.
`9/2002 Rhodes
`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.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 2
`
`

`

`US 11,844,943 B2
`Page 3
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`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
`6,770,022 B2
`6,770,480 B1
`6,782,283 B2
`6,790,372 B2
`6,808,506 B2
`6,835,184 B1
`6,866,659 B2
`6,881,203 B2
`6,899,838 B2
`6,904,614 B2
`6,908,453 B2
`6,926,660 B2
`6,931,277 B1
`6,939,311 B2
`6,941,171 B2
`6,960,193 B2
`6,962,772 B2
`6,972,013 B1
`6,980,855 B2
`7,013,179 B2
`7,027,478 B2
`7,032,302 B1
`7,045,069 B2
`7,047,070 B2
`7,048,723 B1
`7,079,355 B2
`7,083,592 B2
`7,104,947 B2
`7,115,108 B2
`7,117,034 B2
`7,130,696 B2
`7,132,054 B1
`7,153,256 B2
`7,187,976 B2
`7,226,439 B2
`7,262,068 B2
`7,273,474 B2
`7,285,113 B2
`7,315,758 B2
`7,316,665 B2
`7,320,664 B2
`7,332,197 B2
`7,332,339 B2
`7,344,499 B1
`7,367,936 B2
`D571,920 S
`7,396,326 B2
`7,410,476 B2
`7,415,299 B2
`7,416,541 B2
`7,429,333 B2
`7,473,244 B2
`7,481,337 B2
`7,497,980 B2
`7,500,911 B2
`7,520,848 B2
`7,522,061 B2
`7,530,968 B2
`7,536,226 B2
`7,556,615 B2
`7,556,821 B2
`7,560,036 B2
`7,570,992 B2
`7,572,405 B2
`
`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
`8/2004 Mechlenburg et al.
`8/2004 Canham
`8/2004 Schmidt et al.
`9/2004 Roy et al.
`10/2004 Lastovich et al.
`12/2004 Sage et al.
`3/2005 Nemati
`4/2005 Delmore et al.
`5/2005 Lastovich
`6/2005 Yamazaki et al.
`6/2005 Fleming et al.
`8/2005 Miller
`8/2005 Yuzhakov et al.
`9/2005 Geiger
`9/2005 Mann et al.
`11/2005 Rosenberg
`11/2005 Liu et al.
`12/2005 Zhang et al.
`12/2005 Cho
`3/2006 Carter et al.
`4/2006 Ackley
`4/2006 Schmidt et al.
`5/2006 Ozeiyansky
`5/2006 Wilkinson et al.
`5/2006 Frazier et al.
`7/2006 Hsiao et al.
`8/2006 Lastovich et al.
`9/2006 Riehl
`10/2006 Wilkinson et al.
`10/2006 Kronberg
`10/2006 Carter et al.
`11/2006 Kravitz et al.
`12/2006 Riehl et al.
`3/2007 Duncan et al.
`6/2007 Prausnitz et al.
`8/2007 Roy et al.
`9/2007 Chang et al.
`10/2007 Yeshurun
`1/2008 Kwiatkowski et al.
`1/2008 Laurent et al.
`1/2008 Riehl et al.
`2/2008 Wood et al.
`2/2008 Canham
`3/2008 Prausnitz et al.
`5/2008 Myers et al.
`6/2008 Juliana et al.
`7/2008 Ghiron et al.
`8/2008 Wilkinson et al.
`8/2008 Zimmermann et al.
`8/2008 Yuzhakov et al.
`9/2008 Chiou et al.
`1/2009 Frazier et al.
`1/2009 Luharuka et al.
`3/2009 Xu et al.
`3/2009 Johnson et al.
`4/2009 Schneider et al.
`4/2009 Rondoni et al.
`5/2009 Gonnelli
`5/2009 Williams et al.
`7/2009 Pettis et al.
`7/2009 Amen et al.
`7/2009 Golubovic-Liakopoulos et al.
`8/2009 Nolan et al.
`8/2009 Sherman et al.
`
`7,574,256 B2
`7,578,954 B2
`7,582,069 B2
`7,588,552 B2
`7,591,806 B2
`7,627,938 B2
`7,628,761 B2
`7,647,112 B2
`7,648,484 B2
`7,651,946 B2
`7,658,728 B2
`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
`11,224,742 B2
`11,247,053 B2
`11,628,300 B2
`2002/0007128 Al
`2002/0007129 Al
`2002/0028991 Al
`2002/0040233 Al
`2002/0055761 Al
`2002/0082465 Al
`2002/0099323 Al
`2002/0111777 Al
`2002/0133129 Al
`2002/0138116 Al
`2002/0183647 Al
`2002/0183804 Al
`2003/0003968 Al
`2003/0004392 Al
`2003/0028072 Al
`2003/0144625 Al
`2003/0158583 Al
`2003/0158585 Al
`2003/0216729 Al
`2003/0217754 Al
`2004/0010276 Al
`2004/0015188 Al
`2004/0054393 Al
`2004/0082875 Al
`2004/0088036 Al
`2004/0092860 Al
`2004/0102819 Al
`2004/0111139 Al
`2004/0122787 Al
`2004/0127939 Al
`2004/0138517 Al
`2004/0146611 Al
`2004/0147964 Al
`2004/0173220 Al
`2004/0210254 Al
`2004/0210282 Al
`2004/0237170 Al
`2005/0021104 Al
`2005/0029223 Al
`2005/0033380 Al
`2005/0099290 Al
`2005/0107654 Al
`2005/0143783 Al
`
` A61N 2/008
`
` A61N 1/36007
`
`Carter
`8/2009
`Gartstein et al.
`8/2009
`Laurent et al.
`9/2009
`Yeshurun et al.
`9/2009
`9/2009 Xu
`12/2009 Kim et al.
`12/2009 Gozani et al.
`1/2010 Tracey et al.
`1/2010 Yeshurun et al.
`1/2010 Wilke et al.
`2/2010 Yuzhakov
`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.
`1/2022 Burnett
`2/2022 Rajguru et al.
`4/2023 Rajguru et al.
`1/2002 Ives et al.
`1/2002 Marino
`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 Gozani et al.
`12/2002 Malaney et al.
`1/2003 Muraki
`1/2003 Tanner et al.
`2/2003 Fische11 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 Bruce
`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.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 3
`
`

`

`US 11,844,943 B2
`Page 4
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2005/0143789 Al
`2005/0171576 Al
`2005/0203602 Al
`2005/0240230 Al
`2005/0277998 Al
`2005/0283202 Al
`2005/0283204 Al
`2006/0004244 Al
`2006/0015153 Al
`2006/0016452 Al
`2006/0030845 Al
`2006/0047316 Al
`2006/0047326 Al
`2006/0049957 Al
`2006/0052839 Al
`2006/0069415 Al
`2006/0084938 Al
`2006/0115130 Al
`2006/0122454 Al
`2006/0122660 Al
`2006/0135844 Al
`2006/0155345 Al
`2006/0161039 Al
`2006/0173261 Al
`2006/0178576 Al
`2006/0184211 Al
`2006/0199159 Al
`2006/0276702 Al
`2007/0021712 Al
`2007/0021803 Al
`2007/0027353 Al
`2007/0027354 Al
`2007/0027355 Al
`2007/0142885 Al
`2007/0208212 Al
`2007/0250162 Al
`2007/0265489 Al
`2007/0265675 Al
`2007/0276318 Al
`2007/0282246 Al
`2008/0004484 Al
`2008/0033510 Al
`2008/0058874 Al
`2008/0063866 Al
`2008/0065167 Al
`2008/0097142 Al
`2008/0114199 Al
`2008/0177128 Al
`2008/0177347 Al
`2008/0183070 Al
`2008/0200748 Al
`2008/0224808 Al
`2008/0262287 Al
`2008/0288035 Al
`2008/0300655 Al
`2008/0306325 Al
`2008/0312725 Al
`2009/0030337 Al
`2009/0054950 Al
`2009/0073991 Al
`2009/0076336 Al
`2009/0076340 Al
`2009/0076344 Al
`2009/0076345 Al
`2009/0076363 Al
`2009/0076364 Al
`2009/0076397 Al
`2009/0076410 Al
`2009/0076559 Al
`2009/0076565 Al
`2009/0099623 Al
`2009/0118777 Al
`2009/0132018 Al
`2009/0162570 Al
`2009/0171236 Al
`
`6/2005
`8/2005
`9/2005
`10/2005
`12/2005
`12/2005
`12/2005
`1/2006
`1/2006
`1/2006
`2/2006
`3/2006
`3/2006
`3/2006
`3/2006
`3/2006
`4/2006
`6/2006
`6/2006
`6/2006
`6/2006
`7/2006
`7/2006
`8/2006
`8/2006
`8/2006
`9/2006
`12/2006
`1/2007
`1/2007
`2/2007
`2/2007
`2/2007
`6/2007
`9/2007
`10/2007
`11/2007
`11/2007
`11/2007
`12/2007
`1/2008
`2/2008
`3/2008
`3/2008
`3/2008
`4/2008
`5/2008
`7/2008
`7/2008
`7/2008
`8/2008
`9/2008
`10/2008
`11/2008
`12/2008
`12/2008
`12/2008
`1/2009
`2/2009
`3/2009
`3/2009
`3/2009
`3/2009
`3/2009
`3/2009
`3/2009
`3/2009
`3/2009
`3/2009
`3/2009
`4/2009
`5/2009
`5/2009
`6/2009
`7/2009
`
`Whitehurst et al.
`Williams et al.
`Wallace et al.
`Preston et al.
`Tracey et al.
`Gellman
`Buhlmann et al.
`Phillips et al.
`Gliner et al.
`Goetz et al.
`Leung et al.
`Fischell et al.
`Wheeler
`Surgenor et al.
`Kim et al.
`Cameron et al.
`Zhang et al.
`Kozlay
`Riehl et al.
`Boveja et al.
`Alekseyenko
`Williams et al.
`Juliana et al.
`Kall et al.
`Weber et al.
`Gaunt et al.
`Ghiron et al.
`Mcginnis
`Bernard et al.
`Deem et al.
`Ghiron et al.
`Riehl et al.
`Riehl et al.
`Hantash et al.
`Dilorenzo
`Royalty
`Fowler et al.
`Lund et al.
`Henley
`Henley
`Wieraszko et al.
`Herregraven et al.
`Westlund et al.
`Allen et al.
`Boggs et al.
`Savage
`Riehl et al.
`Riehl et al.
`Tehrani et al.
`Unal et al.
`Testani et al.
`Ghiron et al.
`Dussau
`Gill et al.
`Cholette
`Burnett et al.
`Penner
`Gozani et al.
`Stephens
`Landrum et al.
`Mazar et al.
`Libbus et al.
`Libbus et al.
`Manicka et al.
`Bly et al.
`Libbus et al.
`Libbus et al.
`Libbus et al.
`Libbus et al.
`Surwit
`Bentwich
`Iki et al.
`DiUbaldi et al.
`Swenberg et al.
`Davies
`
`2009/0198305 Al
`2009/0227829 Al
`2009/0227831 Al
`2009/0234179 Al
`2009/0234410 Al
`2009/0264792 Al
`2009/0292194 Al
`2010/0016929 Al
`2010/0022864 Al
`2010/0049021 Al
`2010/0056881 Al
`2010/0057147 Al
`2010/0057149 Al
`2010/0114259 Al
`2010/0119482 Al
`2010/0160712 Al
`2010/0161005 Al
`2010/0168501 Al
`2010/0204538 Al
`2010/0222629 Al
`2010/0222630 Al
`2010/0318009 Al
`2011/0021863 Al
`2011/0144468 Al
`2011/0264163 Al
`2011/0270140 Al
`2011/0295100 Al
`2012/0059432 Al
`2012/0101326 Al
`2012/0302821 Al
`2013/0006322 Al
`2013/0072746 Al
`2013/0072835 Al
`2014/0046423 Al
`2014/0148870 Al
`2014/0213842 Al
`2013/0310909 Al
`2014/0249595 Al
`2014/0288613 Al
`2015/0190648 Al
`2015/0202454 Al
`2015/0227909 Al
`2015/0260471 Al
`2016/0067515 Al
`2016/0067517 Al
`2016/0074671 Al
`2016/0193466 Al
`2017/0354831 Al
`2018/0050216 A9
`2018/0133472 Al
`2020/0139120 Al
`2021/0299445 Al
`2022/0088373 Al
`2022/0021007 Al
`2023/0201584 Al
`
`8/2009
`9/2009
`9/2009
`9/2009
`9/2009
`10/2009
`11/2009
`1/2010
`1/2010
`2/2010
`3/2010
`3/2010
`3/2010
`5/2010
`5/2010
`6/2010
`6/2010
`7/2010
`8/2010
`9/2010
`9/2010
`12/2010
`1/2011
`6/2011
`10/2011
`11/2011
`12/2011
`3/2012
`4/2012
`11/2012
`1/2013
`3/2013
`3/2013
`2/2014
`5/2014
`7/2014
`9/2014
`9/2014
`9/2014
`7/2015
`7/2015
`8/2015
`9/2015
`3/2016
`3/2016
`3/2016
`7/2016
`12/2017
`2/2018
`5/2018
`5/2020
`9/2021
`3/2022
`7/2022
`6/2023
`
`Naroditsky et al.
`Burnett et al.
`Burnett et al.
`Burnett et al.
`Libbus et al.
`Mazar
`Libbus et al.
`Prochazka
`Cordero et al.
`Jina et al.
`Libbus et al.
`Fassih et al.
`Fahey
`Herregraven et al.
`Yun et al.
`Burnett et al.
`Wahlgren et al.
`Burnett et al.
`Burnett et al.
`Burnett et al.
`Mangrum et al.
`Stanley
`Burnett et al.
`Boggs et al.
`Tracey et al.
`Israeli
`Hedge et al.
`Emborg et al.
`Simon et al.
`Burnett
`Tai
`Burnett et al.
`Harry et al.
`Raj guru et al.
`Burnett
`Simon et al.
`Simon et al.
`Chancellor et al.
`Laing et al.
`Fische11 et al.
`Burnett
`Laing et al.
`Azhocar
`Burnett et al.
`Burnett
`Burnett et al.
`Burnett
`Burnett
`Burnett
`Tai
`Raj guru et al.
`Raj guru et al.
`Burnett
`Raj guru et al.
`Raj guru et al.
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`EP
`EP
`GB
`GB
`GB
`JP
`JP
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`2456519
`2493551
`2493552
`2618890
`0637560
`2298370
`2336544
`2000-254239
`2009-153904
`WO 2003/070317
`W02004108209 Al '1'
`WO 2006/061688
`WO 2006/092007
`WO 2008/032279
`WO 2008/042902
`WO 2008/115426
`WO 2010/047599
`WO 2010/084482
`WO 2011/011748
`WO 2011/011749
`WO 2011/053607
`
`5/2012
`9/2012
`9/2012
`7/2013
`5/1950
`9/1996
`10/1999
`9/2000
`7/2009
`8/2003
`12/2004
`6/2006
`9/2006
`3/2008
`4/2008
`9/2008
`4/2010
`7/2010
`1/2011
`1/2011
`5/2011
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 4
`
`

`

`US 11,844,943 B2
`Page 5
`
`(56)
`
`References Cited
`
`FOREIGN PATENT DOCUMENTS
`
`WO WO 2011/053661
`WO WO 2011/150332
`WO WO 2011/150502
`WO WO 2012/040243
`WO WO 2014/151431
`
`5/2011
`12/2011
`12/2011
`3/2012
`9/2014
`
`OTHER PUBLICATIONS
`
`"Tibial Nerve." Wikipedia, accessed Oct. 5, 2020, https://en.wikipedia.
`org/wiki/Tibial_nerve. (Year: 2020).
`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.
`Amarenco et al., "Urodynamic effect of acute transcutaneous pos-
`terior tibial nerve stimulation in overactive bladder," Journal of
`Urology, vol. 169, 2210-2215. (Jun. 2003).
`AmGel Technologies, "AG603 Sensing Gel, Sensing Gel Designed
`for ECG Applications," AG603-3/10, 1 p. 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.
`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 using
`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-
`gery, 6 pages, 2004.
`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. Gill 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 ((3AR) 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 al., 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).
`Lunge, R. "Microneedle array electrode for human EEG recording,"
`IFMBE Proceedings 22, pp. 1246-1249, 2008, Springer-Verlag
`Berlin 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.
`PubMed, U.S. National Library of Medicine National Institutes of
`Health, microneedle array electrode Pub 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 electrode Pub Med results, www.ncbi.nlm.
`nig.gov/sites/entrez, 7 pages, Search performed on Apr. 22, 2010.
`Schaefer, 0. 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 al., "Comparison of Electroanatomic Contact
`and Noncontact Mapping of Ventricular Scar in a Postinfarct Ovine
`Model With Intramural Needle Electrode Recording and Histologi-
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 5
`
`

`

`US 11,844,943 B2
`Page 6
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`cal Validation," Circulation: Arrhythmia and Electrophysiology,
`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.
`VanSonnenberg, 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.
`
`Wanich, T. et al, "A Randomized Placebo-Controlled Study to
`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.
`Amarenco et al., "Urodynamic Effect of Acute Transcutaneous
`Posterior Tibial Nerve Stimulation in Overactive Bladder," The
`Journal of Urology, vol. 169, pp. 2210-2215, Jun. 2003.T
`
`* cited by examiner
`cited by third party
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 6
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 1 of 72
`
`US 11,844,943 B2
`
`FIG. 1
`
`44
`
`fitS. 2
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 7
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 2 of 72
`
`US 11,844,943 B2
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 8
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 3 of 72
`
`US 11,844,943 B2
`
`5
`
`F1 4
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 9
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 4 of 72
`
`US 11,844,943 B2
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 10
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 5 of 72
`
`US 11,844,943 B2
`
`--e
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 11
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 6 of 72
`
`US 11,844,943 B2
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 12
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 7 of 72
`
`US 11,844,943 B2
`
`•
`
`i
`
`Siv
`
`0,4
`
`(7).4
`
`ar
`
`40
`
`4
`
`C'
`
`04
`
`•••••6w....40)(t,
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 13
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 8 of 72
`
`US 11,844,943 B2
`
`12
`
`s.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 14
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 9 of 72
`
`US 11,844,943 B2
`
`33
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 15
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 10 of 72
`
`US 11,844,943 B2
`
`•••
`
`V 4
`
`4:
`
`•
`
`4
`
`4
`
`4
`
`•
`
`.
`
`a
`
`4
`
`t
`
`n
`
`0
`
`r
`
`%
`
`v
`
`n
`
`n•
`
`v
`
`Y
`
`a
`
`a
`
`•
`
`•
`
`n
`
`n
`
`n
`
`a
`
`t
`
`> a
`
`'0
`
`a
`
`4
`
`4:
`
`4
`
`•
`
`a
`
`4
`
`9
`
`•
`
`A
`
`v
`
`V
`
`#
`
`n
`
`en
`
`a
`
`ne
`
`.i
`
`nC V
`
`▪
`
`n a
`
`a
`
`a
`
`6
`
`4.
`
`6
`
`6 Y
`
`e. a
`
`IN.
`
`4
`
`t
`
`•
`
`4
`
`4
`
`9
`
`9
`
`f
`
`v
`
`4
`
`•
`
`V
`
`•
`
`4
`
`V o
`
`v
`
`e
`
`n,
`
`4e.
`
`•
`
`•
`
`a
`
`a
`
`a
`
`a
`
`4
`
`V
`
`4
`
`•
`
`4
`
`a
`
`•
`
`t
`
`t
`
`4
`
`4 P
`
`r
`
`•
`
`•
`
`r
`
`I
`
`a
`
`w A
`
`4.
`
`a
`
`4
`
`In a
`
`M1
`
`)
`.
`44.4. 44• 44avannanananfinfivannavv< 440404444444444404444•444444•44
`
`FIG, A
`
`V
`
`x
`
`44
`
`4
`
`4
`
`44
`
`0
`
`•
`
`a
`
`44
`
`4
`
`44
`
`0
`
`fi
`
`4
`
`•
`
`44
`
`a
`
`a
`
`a
`
`»
`
`H
`
`%
`
`a
`
`4
`
`a
`
`n<
`
`0
`
`•
`
`FIG
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 16
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 11 of 72
`
`US 11,844,943 B2
`
`2.3
`
`iY
`
`-77
`
`\--23L
`
`0
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 17
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 12 of 72
`
`US 11,844,943 B2
`
`<>s'* ".*
`,,, 42,
`440, Cs Ch
`„
`44.
` ti
`
`I
`
`0
`
`xn.
`
`x:s
`
`*
`
`ral
`
`,a4
`
`1 ,
`
`O
`wr a
`f0. s2k
`<,
`'
`
`— 240
`
`234
`
`".—.•
`cc
`1;2,
` u"
`.1.,..0
`ir.„, 0
`0
`qw.,
`0,,
`-
`-0i -.p
`A,E)':.- ' ,-."04.°
`0/
`0.> c.,, 4..,,,.2.
`1.... 440. e>
`
`..."
`
`II,
`
`
`
`311
`
`o
`
`--239
`
`R,
`
`„.
`
`p
`P'' *
`
`beN `',,f•Z''
`
`+. ••• 0
`
`*) . -- 4.
`"
`
`V
`
`,
`
`cz,,2 0
`
`*2' 4i.
`p?
`
`38
`
`kz ., r .,,,, vx..(:,:,
`4.(
`
`If 14.4.:V2.}: • s:C ,
`
`A
`
`.
`
`/ -223
`
`-18
`
`Ha 19
`
`Petitioner - Avation Medical, Inc.
`Ex. 1001, p. 18
`
`

`

`U.S. Patent
`
`Dec. 19, 2023
`
`Sheet 13 of 72
`
`US 11,844,943 B2
`
`F
`
`r rik
`
`2v a
`
`iii
`
`r
`
`F
`
`P