throbber
Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AVATION MEDICAL, INC.,
`Petitioner
`v.
`
`EMKINETICS, INC.,
`Patent Owner
`
`U.S. PATENT NO. 11,844,943
`Case No. PGR2024-00043
`
`EX. 1003 - DECLARATION OF DR. BRETT WINGEIER
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 1
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`Table of Contents
`
`INTRODUCTION .........................................................................................16
`I.
`QUALIFICATIONS ......................................................................................17
`II.
`III. MATERIALS REVIEWED AND CONSIDERED ......................................20
`IV.
`SCOPE OF OPINION ...................................................................................21
`V.
`LEVEL OF ORDINARY SKILL IN THE ART ...........................................22
`VI.
`LEGAL PRINCIPLES ...................................................................................24
`A.
`Anticipation/Obviousness ...................................................................24
`B.
`Enablement ..........................................................................................28
`C.
`Priority Date ........................................................................................28
`VII. BACKGROUND OF THE TECHNOLOGY ................................................29
`A.
`Overactive Bladder (“OAB”) and Incontinence .................................29
`B.
`Treatment of OAB and Incontinence ..................................................30
`VIII. U.S. PATENT NO. 11,844,943 (“’943 patent”)............................................41
`A.
`Overview of the ’943 Patent ................................................................41
`B.
`Prosecution History of the ’943 Patent ...............................................46
`IX. CLAIM CONSTRUCTION ..........................................................................47
`X.
`SPECIFIC GROUNDS OF CHALLENGE ...................................................47
`A.
`Ground 1: Claims 1 and 3-5 Are Anticipated by Svihra (Ex.1004)....47
`1.
`Claim 1: .....................................................................................48
`2.
`Claim 3: The method of claim 1 further comprising
`detecting a muscular response caused by an electrical
`conduction or stimulation of the posterior tibial nerve. ............55
`Claim 4: The method of claim 1 wherein delivering the
`electrical stimulus comprises activating the electrical
`stimulator for a duration of about 30 minutes per week to
`treat the patient. .........................................................................56
`Claim 5: The method of claim 1 further comprising
`displaying physiological parameters detected from the
`patient. .......................................................................................56
`
`3.
`
`4.
`
`2
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 2
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`B.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Ground 2: Claims 2 and 6-13 Are Obvious Over Svihra (Ex.1004) in
`View of the Knowledge of a POSA ....................................................57
`1.
`Claim 2: The method of claim 1 wherein non-invasively
`positioning comprises positioning an electrode patch in
`communication with the electrical stimulator near an
`ankle of the patient. ...................................................................57
`Claim 6: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode migration from
`the first portion. .........................................................................61
`Claim 7: The method of claim 6 wherein detecting for the
`presence of electrical conduction comprises detecting via
`an electrode patch positioned upon the second portion. ...........71
`Claim 8: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode malfunction from
`the first portion. .........................................................................74
`Claim 9: The method of claim 8 wherein detecting for the
`presence of electrical conduction comprises detecting via
`an electrode patch positioned upon the second portion. ...........74
`Claim 10: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of proper electrode placement
`upon the first portion. ................................................................75
`Claim 11: The method of claim 10 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ......................................................................................75
`Claim 12: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`through tissue at a second portion of the patient's body
`distant from the first portion as an indicator of electrode
`placement upon the first porion. ...............................................76
`Claim 13: The method of claim 12 wherein detecting for
`the presence of electrical conduction through tissue
`
`7.
`
`8.
`
`9.
`
`3
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 3
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`C.
`
`D.
`
`3.
`
`4.
`
`5.
`6.
`
`comprises detecting via an electrode patch positioned
`upon the second portion. ...........................................................76
`Ground 3: Claims 14, 16-18, 27, and 29-31 Are Obvious Over Svihra
`(Ex.1004) in View of Johnson (Ex.1007) ...........................................77
`1.
`Claim 14: ...................................................................................77
`2.
`Claim 16: The method of claim 14 further comprising
`detecting a muscular response caused by an electrical
`conduction or stimulation of the posterior tibial nerve. ............80
`Claim 17: The method of claim 14 wherein delivering the
`electrical stimulus comprises activating the electrical
`stimulator for a duration of about 30 minutes per week to
`treat the patient. .........................................................................80
`Claim 18: The method of claim 14 further comprising
`displaying physiological parameters detected from the
`patient. .......................................................................................81
`Claim 27: ...................................................................................81
`Claim 29: The method of claim 27 further comprising
`detecting a muscular response caused by an electrical
`conduction or stimulation of the posterior tibial nerve. ............83
`Claim 30: The method of claim 27 wherein delivering the
`electrical stimulus comprises activating the electrical
`stimulator for a duration of about 30 minutes per week to
`treat the patient. .........................................................................84
`Claim 31: The method of claim 27 further comprising
`displaying physiological parameters detected from the
`patient. .......................................................................................84
`Ground 4: Claims 15, 19-26, 28, and 32-39 Are Obvious Over Svihra
`(Ex.1004) in View of Johnson (Ex.1007) and the Knowledge of a
`POSA ...................................................................................................84
`1.
`Claim 15: The method of claim 14 wherein non-
`invasively positioning comprises positioning an electrode
`patch in communication with the electrical stimulator
`near an ankle of the patient. ......................................................85
`Claim 19: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode migration from
`the first portion. .........................................................................85
`
`7.
`
`8.
`
`2.
`
`4
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 4
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`3.
`
`4.
`
`5.
`
`6.
`
`Claim 20: The method of claim 19 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ......................................................................................86
`Claim 21: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode malfunction from
`the first portion. .........................................................................86
`Claim 22: The method of claim 21 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ......................................................................................87
`Claim 23: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of proper electrode placement
`upon the first portion. ................................................................87
`Claim 24: The method of claim 23 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ......................................................................................88
`Claim 25: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`through tissue at a second portion of the patient's body
`distant from the first portion as an indicator of electrode
`placement upon the first potion.................................................88
`Claim 26: The method of claim 25 wherein detecting for
`the presence of electrical conduction through tissue
`comprises detecting via an electrode patch positioned
`upon the second portion. ...........................................................89
`10. Claim 28: The method of claim 27 wherein non-
`invasively positioning comprises positioning an electrode
`patch in communication with the electrical stimulator
`near an ankle of the patient. ......................................................90
`11. Claim 32: The method of claim 27 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`
`7.
`
`8.
`
`9.
`
`5
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 5
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`first portion as an indicator of electrode migration from
`the first portion. .........................................................................90
`12. Claim 33: The method of claim 32 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ......................................................................................91
`13. Claim 34: The method of claim 27 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode malfunction from
`the first portion. .........................................................................91
`14. Claim 35: The method of claim 34 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ......................................................................................92
`15. Claim 36: The method of claim 27 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of proper electrode placement
`upon the first portion. ................................................................92
`16. Claim 37: The method of claim 36 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ......................................................................................93
`17. Claim 38: The method of claim 27 further comprising
`detecting for a lack of presence of electrical conduction
`through tissue at a second portion of the patient's body
`distant from the first portion as an indicator of electrode
`placement upon the first potion.................................................93
`18. Claim 39: The method of claim 38 wherein detecting for
`the presence of electrical conduction through tissue
`comprises detecting via an electrode patch positioned
`upon the second portion. ...........................................................94
`Ground 5: Claims 1-3 and 5 Are Anticipated by Amarenco (Ex.1005)
` .............................................................................................................94
`1.
`Claim 1: .....................................................................................95
`2.
`Claim 2: The method of claim 1 wherein non-invasively
`positioning comprises positioning an electrode patch in
`
`6
`
`E.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 6
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`3.
`
`4.
`
`F.
`
`communication with the electrical stimulator near an
`ankle of the patient. ...................................................................98
`Claim 3: The method of claim 1 further comprising
`detecting a muscular response caused by an electrical
`conduction or stimulation of the posterior tibial nerve. ............99
`Claim 5: The method of claim 1 further comprising
`displaying physiological parameters detected from the
`patient. .....................................................................................100
`Ground 6: Claims 4 and 6-13 Are Obvious Over Amarenco (Ex.1005)
`in View of the Knowledge of a POSA ..............................................102
`1.
`Claim 4: The method of claim 1 wherein delivering the
`electrical stimulus comprises activating the electrical
`stimulator for a duration of about 30 minutes per week to
`treat the patient. .......................................................................102
`Claim 6: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode migration from
`the first portion. .......................................................................103
`Claim 7: The method of claim 6 wherein detecting for the
`presence of electrical conduction comprises detecting via
`an electrode patch positioned upon the second portion. .........113
`Claim 8: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode malfunction from
`the first portion. .......................................................................115
`Claim 9: The method of claim 8 wherein detecting for the
`presence of electrical conduction comprises detecting via
`an electrode patch positioned upon the second portion. .........116
`Claim 10: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of proper electrode placement
`upon the first portion. ..............................................................116
`Claim 11: The method of claim 10 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ....................................................................................117
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`7
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 7
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`8.
`
`9.
`
`G.
`
`H.
`
`Claim 12: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`through tissue at a second portion of the patient's body
`distant from the first portion as an indicator of electrode
`placement upon the first porion. .............................................117
`Claim 13: The method of claim 12 wherein detecting for
`the presence of electrical conduction through tissue
`comprises detecting via an electrode patch positioned
`upon the second portion. .........................................................118
`Ground 7: Claims 14-16, 18, 27-29, and 31 Are Obvious Over
`Amarenco (Ex.1005) in View of Johnson (Ex.1007) ........................118
`1.
`Claim 14: .................................................................................119
`2.
`Claim 15: The method of claim 14 wherein non-
`invasively positioning comprises positioning an electrode
`patch in communication with the electrical stimulator
`near an ankle of the patient. ....................................................122
`Claim 16: The method of claim 14 further comprising
`detecting a muscular response caused by an electrical
`conduction or stimulation of the posterior tibial nerve. ..........122
`Claim 18: The method of claim 14 further comprising
`displaying physiological parameters detected from the
`patient. .....................................................................................122
`Claim 27: .................................................................................122
`Claim 28: The method of claim 27 wherein non-
`invasively positioning comprises positioning an electrode
`patch in communication with the electrical stimulator
`near an ankle of the patient. ....................................................125
`Claim 29: The method of claim 27 further comprising
`detecting a muscular response caused by an electrical
`conduction or stimulation of the posterior tibial nerve. ..........125
`Claim 31: The method of claim 27 further comprising
`displaying physiological parameters detected from the
`patient. .....................................................................................126
`Ground 8: Claims 17, 19-26, 30, and 32-39 Are Obvious Over
`Amarenco (Ex.1005) in View of Johnson (Ex.1007) and the
`Knowledge of a POSA ......................................................................126
`1.
`Claim 17: The method of claim 14 wherein delivering the
`electrical stimulus comprises activating the electrical
`
`3.
`
`4.
`
`5.
`6.
`
`7.
`
`8.
`
`8
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 8
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`stimulator for a duration of about 30 minutes per week to
`treat the patient. .......................................................................127
`Claim 19: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode migration from
`the first portion. .......................................................................127
`Claim 20: The method of claim 19 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ....................................................................................128
`Claim 21: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode malfunction from
`the first portion. .......................................................................128
`Claim 22: The method of claim 21 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ....................................................................................129
`Claim 23: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of proper electrode placement
`upon the first portion. ..............................................................129
`Claim 24: The method of claim 23 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ....................................................................................130
`Claim 25: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`through tissue at a second portion of the patient's body
`distant from the first portion as an indicator of electrode
`placement upon the first potion...............................................130
`Claim 26: The method of claim 25 wherein detecting for
`the presence of electrical conduction through tissue
`comprises detecting via an electrode patch positioned
`upon the second portion. .........................................................131
`
`9
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 9
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`10. Claim 30: The method of claim 27 wherein delivering the
`electrical stimulus comprises activating the electrical
`stimulator for a duration of about 30 minutes per week to
`treat the patient. .......................................................................131
`11. Claim 32: The method of claim 27 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode migration from
`the first portion. .......................................................................132
`12. Claim 33: The method of claim 32 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ....................................................................................132
`13. Claim 34: The method of claim 27 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode malfunction from
`the first portion. .......................................................................133
`14. Claim 35: The method of claim 34 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ....................................................................................134
`15. Claim 36: The method of claim 27 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of proper electrode placement
`upon the first portion. ..............................................................134
`16. Claim 37: The method of claim 36 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ....................................................................................135
`17. Claim 38: The method of claim 27 further comprising
`detecting for a lack of presence of electrical conduction
`through tissue at a second portion of the patient's body
`distant from the first portion as an indicator of electrode
`placement upon the first potion...............................................135
`18. Claim 39: The method of claim 38 wherein detecting for
`the presence of electrical conduction through tissue
`
`10
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 10
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`I.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`comprises detecting via an electrode patch positioned
`upon the second portion. .........................................................136
`Ground 9: Claims 1-3 and 5-13 Are Anticipated by Burnett (Ex.1006)
` ...........................................................................................................136
`1.
`Claim 1: ...................................................................................137
`2.
`Claim 2: The method of claim 1 wherein non-invasively
`positioning comprises positioning an electrode patch in
`communication with the electrical stimulator near an
`ankle of the patient. .................................................................138
`Claim 3: The method of claim 1 further comprising
`detecting a muscular response caused by an electrical
`conduction or stimulation of the posterior tibial nerve. ..........139
`Claim 5: The method of claim 1 further comprising
`displaying physiological parameters detected from the
`patient. .....................................................................................139
`Claim 6: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode migration from
`the first portion. .......................................................................140
`Claim 7: The method of claim 6 wherein detecting for the
`presence of electrical conduction comprises detecting via
`an electrode patch positioned upon the second portion. .........141
`Claim 8: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode malfunction from
`the first portion. .......................................................................141
`Claim 9: The method of claim 8 wherein detecting for the
`presence of electrical conduction comprises detecting via
`an electrode patch positioned upon the second portion. .........142
`Claim 10: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of proper electrode placement
`upon the first portion. ..............................................................142
`10. Claim 11: The method of claim 10 wherein detecting for
`the presence of electrical conduction comprises detecting
`
`8.
`
`9.
`
`11
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 11
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`J.
`
`via an electrode patch positioned upon the second
`portion. ....................................................................................143
`11. Claim 12: The method of claim 1 further comprising
`detecting for a lack of presence of electrical conduction
`through tissue at a second portion of the patient's body
`distant from the first portion as an indicator of electrode
`placement upon the first porion. .............................................143
`12. Claim 13: The method of claim 12 wherein detecting for
`the presence of electrical conduction through tissue
`comprises detecting via an electrode patch positioned
`upon the second portion. .........................................................144
`Ground 10: Claims 4 and 14-39 Are Obvious Over Burnett (Ex.1006)
`in View of Johnson (Ex.1007) and the Knowledge of a POSA ........144
`1.
`Claim 4: The method of claim 1 wherein delivering the
`electrical stimulus comprises activating the electrical
`stimulator for a duration of about 30 minutes per week to
`treat the patient. .......................................................................144
`Claim 14: .................................................................................146
`Claim 15: The method of claim 14 wherein non-
`invasively positioning comprises positioning an electrode
`patch in communication with the electrical stimulator
`near an ankle of the patient. ....................................................148
`Claim 16: The method of claim 14 further comprising
`detecting a muscular response caused by an electrical
`conduction or stimulation of the posterior tibial nerve. ..........149
`Claim 17: The method of claim 14 wherein delivering the
`electrical stimulus comprises activating the electrical
`stimulator for a duration of about 30 minutes per week to
`treat the patient. .......................................................................149
`Claim 18: The method of claim 14 further comprising
`displaying physiological parameters detected from the
`patient. .....................................................................................150
`Claim 19: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode migration from
`the first portion. .......................................................................150
`Claim 20: The method of claim 19 wherein detecting for
`the presence of electrical conduction comprises detecting
`
`2.
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`12
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 12
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`9.
`
`via an electrode patch positioned upon the second
`portion. ....................................................................................151
`Claim 21: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of electrode malfunction from
`the first portion. .......................................................................152
`10. Claim 22: The method of claim 21 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ....................................................................................152
`11. Claim 23: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`at a second portion of the patient's body distant from the
`first portion as an indicator of proper electrode placement
`upon the first portion. ..............................................................153
`12. Claim 24: The method of claim 23 wherein detecting for
`the presence of electrical conduction comprises detecting
`via an electrode patch positioned upon the second
`portion. ....................................................................................153
`13. Claim 25: The method of claim 14 further comprising
`detecting for a lack of presence of electrical conduction
`through tissue at a second portion of the patient's body
`distant from the first portion as an indicator of electrode
`placement upon the first potion...............................................154
`14. Claim 26: The method of claim 25 wherein detecting for
`the presence of electrical conduction through tissue
`comprises detecting via an electrode patch positioned
`upon the second portion. .........................................................154
`15. Claim 27: .................................................................................155
`16. Claim 28: The method of claim 27 wherein non-
`invasively positioning comprises positioning an electrode
`patch in communication with the electrical stimulator
`near an ankle of the patient. ....................................................158
`17. Claim 29: The method of claim 27 further comprising
`detecting a muscular response caused by an electrical
`conduction or stimulation of the posterior tibial nerve. ..........158
`18. Claim 30: The method of claim 27 wherein delivering the
`electrical stimulus comprises activating the electrical
`
`13
`
`Petitioner - Avation Medical, Inc.
`Ex. 1003, p. 13
`
`

`

`Declaration of Dr. Brett Wingeier, PhD
`
`U.S. Patent No. 11,844,943
`
`stimulator for a duration of about 30 minutes per week to
`treat the patient. .......................................................................158
`19. Claim 31: The method of claim 27 further comprising
`displaying physiological parameters detected f

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