`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________
`
`ALLERGAN, INC., ALLERGAN LIMITED, ALLERGAN USA, INC., ZELTIQ
`AESTHETICS, INC., ZELTIQ IRELAND UNLIMITED COMPANY, AND
`REMED CO. LTD.,
`Petitioners
`v.
`BTL MEDICAL TECHNOLOGIES S.R.O.,
`Patent Owner
`
`__________________
`CASE PGR2021-00025
`U.S. PATENT NO. 10,695,576
`Title: Aesthetic method of biological structure treatment by magnetic field
`__________________
`PETITION FOR POST-GRANT REVIEW
`Pursuant to 35 U.S.C. §§ 321-329 and 37 C.F.R. § 42.200 et seq.
`
`
`

`

`TABLE OF CONTENTS
`
`B.
`
`PAGE
`INTRODUCTION .......................................................................................... 1
`I.
`THE ’576 PATENT ........................................................................................ 1
`II.
`III. THIS PETITION MEETS PGR REQUIREMENTS (37 C.F.R. §
`42.204) ............................................................................................................ 3
`A.
`Standing (37 C.F.R. § 42.204(a)) ......................................................... 3
`B.
`The Challenged Claims and Statutory Grounds (37 C.F.R.
`§ 42.204(b)(1), (2), (4), & (5)) ............................................................. 3
`Claim Construction (37 C.F.R. § 42.204(b)(3)) ................................... 4
`C.
`POSITA ................................................................................................ 5
`D.
`IV. MUSCLE STIMULATION DEVICES WERE WELL-KNOWN IN
`THE ART ........................................................................................................ 6
`A.
`The Principles Of Bioelectricity For Inducing Muscle
`Contraction Were Well Understood ..................................................... 6
`Using Magnetic And Electrical Stimulation For Muscle
`Contraction Was Well-Known ............................................................. 7
`Using Stimulation Devices For Toning Muscle Was Also Well-
`Known .................................................................................................. 9
`V. GROUNDS 1-5: THE CHALLENGED CLAIMS ARE
`UNPATENTABLE UNDER § 103 .............................................................. 11
`A.
`REFERENCE OVERVIEWS ............................................................ 12
`1.
`Burnett ’585: Augmenting Abdominal Muscle Size with
`Magnetic Stimulation Device Coupled To Body ..................... 12
`Burnett ’821: Integrating Cooling Into Magnetic
`Stimulation Device Coils ......................................................... 12
`Johari: Ramped Pulse Sequences At Different Repetition
`Rates ......................................................................................... 12
`Errico: Mobile Device Nerve Stimulation ............................... 13
`4.
`5. Magstim: Magnetic Stimulation Devices For Muscle
`Training .................................................................................... 13
`Porcari: Electrical Stimulation For Toning Abdominal
`Muscles .................................................................................... 15
`-i-
`
`
`6.
`
`
`
`
`
`C.
`
`2.
`
`3.
`
`

`

`TABLE OF CONTENTS
`(Continued)
`
`PAGE
`
`7.
`
`B.
`
`3.
`
`4.
`
`5.
`6.
`7.
`8.
`9.
`
`Jalinous: Magnetic Stimulation Using Two Coils
`(Applicators) ............................................................................ 16
`Phillips: Magnetic Coil Liquid Cooling System ..................... 16
`8.
`9. Mo: Ramp Modulation (Trapezoidal Envelope) ..................... 17
`Ground 1: Claims 1-23 And 25-30 Are Obvious Over
`Burnett ’585 In View Of Johari And Burnett ’821 ............................ 18
`1.
`Independent Claim 1 ................................................................ 19
`2.
`Claim 2 (hold applicators proximate to left/right muscles)
`(108:6-17) ................................................................................. 31
`Claim 3 (simultaneously generate magnetic fields)
`(109:18-22) ............................................................................... 32
`Claim 4 (plurality of pulses, time period of no impulse)
`(109:23-27) ............................................................................... 33
`Claim 5 (inner and outer radii) (109:28-32) ............................ 33
`Claim 6 (constant pulse repetition rates) (109:33-36) ............. 34
`Claim 7 (pulse durations) (109:37-45) ..................................... 34
`Independent Claim 8 ................................................................ 34
`Claim 9 (synchronously generated magnetic fields)
`(110:35-38) ............................................................................... 38
`10. Claim 10 (equal inductances) (110:39-44) .............................. 38
`11. Claim 11 (plurality of pulses, repetition rate, muscle
`contraction, different areas of body region) (110:45-58) ........ 38
`12. Claim 12 (cooling media, magnetic fields, single
`treatment) (110:59-63) ............................................................. 38
`13. Claim 13 (varying repetition rates) (110:64-66; 111:1-18) ..... 39
`14. Claim 14 (bursts, repetition rates, time with no magnetic
`pulse) (111:19-34) .................................................................... 39
`15. Claim 15 (radiofrequency electrode) (111:35-36) ................... 40
`16.
`Independent Claim 16 .............................................................. 41
`
`
`
`
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`-ii-
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`

`

`TABLE OF CONTENTS
`(Continued)
`
`PAGE
`
`17. Claim 17 (holding applicators proximate to left/right
`muscles) (112:33-46) ............................................................... 45
`18. Claim 18 (independently positioned, inductances)
`(112:47-55) ............................................................................... 45
`19. Claim 19 (connecting tubes, source of cooling liquid)
`(112:56-61) ............................................................................... 45
`20. Claim 20 (belt, single treatment) (112:62-65) ......................... 45
`21. Claim 21 (positioning applicators) (112:66-67; 113:1-4) ........ 45
`22. Claim 22 (laterally positioning, dorsal/ventral sides)
`(113:5-10) ................................................................................. 45
`Independent Claim 23 .............................................................. 46
`23.
`24. Claim 25 (independently generate magnetic fields)
`(114:17-19) ............................................................................... 48
`25. Claim 26 (optical waves) (114:20-23) ..................................... 48
`26. Claim 27 (plurality of bursts, time periods, repetition
`rate, increasing/decreasing amplitude) (114:24-35) ................ 49
`27. Claim 28 (pulse repetition rates) (114:36-45) ......................... 49
`28. Claim 29 (constant repetition rates) (114:46-48) ..................... 49
`29. Claim 30 (pulse sequence, varying amplitudes) (114:49-
`65) ............................................................................................ 49
`Ground 2: Claim 24 Is Obvious Over Burnett ’585 In View Of
`Johari, Burnett ’821, And Errico ........................................................ 49
`1.
`Claim 24 (billing system) (114:12-16) .................................... 50
`D. Ground 3: Claims 1-15, 23, 25, And 28-29 Are Obvious In
`View Of Magstim, Jalinous, Porcari, And Phillips ............................ 50
`1.
`Independent Claim 1 ................................................................ 55
`2.
`Claim 2 (hold applicators proximate to left/right muscles)
`(108:6-17) ................................................................................. 71
`Claim 3 (simultaneously generate magnetic fields)
`(109:18-22) ............................................................................... 72
`
`C.
`
`3.
`
`
`
`
`
`-iii-
`
`
`
`

`

`TABLE OF CONTENTS
`(Continued)
`
`PAGE
`
`4.
`
`5.
`6.
`7.
`8.
`9.
`
`Claim 4 (plurality of pulses, time period of no impulse)
`(109:23-27) ............................................................................... 72
`Claim 5 (inner and outer radii) (109:28-32) ............................ 72
`Claim 6 (constant pulse repetition rates) (109:33-36) ............. 73
`Claim 7 (pulse durations) (109:37-45) ..................................... 74
`Independent Claim 8 ................................................................ 75
`Claim 9 (synchronously generated magnetic fields)
`(110:35-38) ............................................................................... 79
`10. Claim 10 (equal inductances) (110:39-44) .............................. 79
`11. Claim 11 (plurality of pulses, repetition rate, muscle
`contraction, different areas of body region) (110:45-58) ........ 79
`12. Claim 12 (cooling media, magnetic fields, single
`treatment) (110:59-63) ............................................................. 80
`13. Claim 13 (varying repetition rates) (110:64-66; 111:1-18) ..... 80
`14. Claim 14 (bursts, repetition rates, time with no magnetic
`pulse) (111:19-34) .................................................................... 80
`15. Claim 15 (radiofrequency electrode) (111:35-36) ................... 81
`16.
`Independent Claim 23 .............................................................. 82
`17. Claim 25 (independently generate magnetic fields)
`(114:17-19) ............................................................................... 85
`18. Claim 28 (pulse repetition rates) (114:36-45) ......................... 85
`19. Claim 29 (constant repetition rates) (114:46-48) ..................... 85
`Ground 4: Claims 16-22, 26-27, And 30 Are Obvious In View
`Of Magstim, Jalinous, Porcari, Phillips, And Mo .............................. 85
`1.
`Independent Claim 16 .............................................................. 89
`2.
`Claim 17 (holding applicators proximate to left/right
`muscles) (112:33-46) ............................................................... 93
`Claim 18 (independently positioned, inductances)
`(112:47-55) ............................................................................... 93
`
`E.
`
`3.
`
`
`
`
`
`-iv-
`
`
`
`

`

`TABLE OF CONTENTS
`(Continued)
`
`PAGE
`
`4.
`
`5.
`6.
`7.
`
`8.
`9.
`
`F.
`
`Claim 19 (connecting tubes, source of cooling liquid)
`(112:56-61) ............................................................................... 93
`Claim 20 (belt, single treatment) (112:62-65) ......................... 94
`Claim 21 (positioning applicators) (112:66-67; 113:1-4) ........ 94
`Claim 22 (laterally positioning, dorsal/ventral sides)
`(113:5-10) ................................................................................. 94
`Claim 26 (optical waves) (114:20-23) ..................................... 94
`Claim 27 (plurality of bursts, time periods, repetition
`rate, increasing/decreasing amplitude) (114:24-35) ................ 95
`10. Claim 30 (pulse sequence, varying amplitudes) (114:49-
`65) ............................................................................................ 95
`Ground 5: Claim 24 Is Obvious In View Of Magstim, Jalinous,
`Porcari, Phillips, And Errico .............................................................. 95
`1.
`Claim 24 (billing system) (114:12-16) .................................... 95
`Secondary Considerations .................................................................. 96
`G.
`INSTITUTION IS WARRANTED .............................................................. 96
`VI.
`VII. CLAIM LISTING ....................................................................................... 101
`VIII. MANDATORY NOTICES ........................................................................ 113
`A.
`Real Party In Interest (37 C.F.R. § 42.8(b)(1)) ................................ 113
`B.
`Related Matters (37 C.F.R. § 42.8(b)(2)) ......................................... 113
`C.
`Identification Of Service Information (37 C.F.R. § 42.8(b)(3)
`and (b)(4)) ......................................................................................... 114
`
`
`
`
`
`
`
`-v-
`
`
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`

`

`PGR2021-00025
`Patent 10,695,576 B2
`
`TABLE OF EXHIBITS
`
`TITLE
`
`EXHIBIT
`NO.
`1001
`
`Reserved
`
`1002
`
`Reserved
`
`1003
`
`U.S. Patent No. 10,695,576 (“ʼ576 patent”)
`
`1004
`
`Reserved
`
`1005
`
`Reserved
`
`1006
`
`Reserved
`
`1007
`
`Reserved
`
`1008
`
`Reserved
`
`1009
`
`Reserved
`
`1010
`
`Abbreviated File History of the ʼ576 patent
`
`1011
`
`Reserved
`
`1012
`
`Reserved
`
`1013
`
`Reserved
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`-i-
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`PGR2021-00025
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`EXHIBIT
`NO.
`1014
`
`Reserved
`
`1015
`
`Chris Hovey BSc & Reza Jalinous PhD, The Guide to Magnetic
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`
`1016
`
`U.S. Patent No. 5,718,662 (“Jalinous”)
`
`1017
`
`U.S. Patent Application Publication No. 2006/0187607 (“Mo”)
`
`1018
`
`U.S. Patent No. 7,591,776 (“Phillips”)
`
`1019
`
`1020
`
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`
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`
`1021
`
`Reserved
`
`1022
`
`Reserved
`
`1023
`
`Declaration of Dr. Pedro Irazoqui
`
`1024
`
`Declaration of Maria P. Garcia
`
`-ii-
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`

`

`PGR2021-00025
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`U.S. Patent Application Publication No. 2011/0190569
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`1027
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`
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`
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`
`1033
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`
`1034
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`
`1035
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`
`
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`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
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`1042
`
`Reserved
`
`1043
`
`Reserved
`
`1044
`
`Reserved
`
`
`
`
`
`-iv-
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`PGR2021-00025
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
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`EXHIBIT
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`1045
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`Reserved
`
`1046
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`
`1047
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`Reserved
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`1048
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`
`1049
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`Iskra Medical, TESLA Stym Brochure (2013)
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`
`
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`PGR2021-00025
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
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`Geddes, History of Magnetic Stimulation of the Nervous System,
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`
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`
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`
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`
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`
`
`
`
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`PGR2021-00025
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
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`U.S. Patent No. 5,766,124 (“Polson”)
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`
`1066
`
`Reserved
`
`1067
`
`U.S. Patent No. 10,413,745 (“Riehl”)
`
`1068
`
`U.S. Patent No. 5,725,471 (“Davey”)
`
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`
`
`
`
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`PGR2021-00025
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
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`U.S. Patent Application Publication No. 2010/0331603 (“Szecsi”)
`
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`
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`
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`Schaefer et al., Review of Patient Safety in Time-Varying Gradient
`Fields, Journal of Magnetic Resonance Imaging, 12:20-29 (2000)
`
`The Oxford Handbook of Transcranial Stimulation, Chapter 3
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`
`1079
`
`Reserved
`
`1080
`
`U.S. Patent Application Publication No. 2013/0238061 (“Edoute”)
`
`1081
`
`Reserved
`
`1082
`
`1083
`
`1084
`
`Gorodnichev et al., Magnetic stimulation of muscles as new method
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`
`Belyaev, Andrey Gennadievich, Effect of magnetic stimulation on
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`
`1085
`
`CV of Pedro Irazoqui
`
`
`
`
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`PGR2021-00025
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
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`
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`
`1093
`
`Declaration of Vladislav Ugryumov (authenticating EX1083,
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`
`
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`PGR2021-00025
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
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`Reserved
`
`BTL’s Response to Respondent’s Motion To Compel Corporate
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`
`EXHIBIT
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`
`1095
`
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`
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`
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`
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`
`1098
`
`1099
`
`1100
`
`Barker, The history and basic principles of magnetic nerve
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`Thompson, Inductance Calculation Techniques – Part II:
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`
`1101
`
`Reserved
`
`1102
`
`Reserved
`
`1103
`
`Reserved
`
`
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`PGR2021-00025
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`EXHIBIT
`NO.
`1104
`
`Reserved
`
`1105
`
`Reserved
`
`1106
`
`U.S. Patent No. 10,610,696 (“Peled”)
`
`
`
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`
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`PGR2021-00025
`Patent 10,695,576 B2
`TABLE OF ABBREVIATIONS
`Abbreviation
`
`Term
`U.S. Patent No. 10,695,576
`BTL Industries, Inc.
`U.S. Patent Publication No.
`2003/0158585
`U.S. Patent Publication No.
`2012/0302821
`Electrical Muscle Stimulation
`International Application Publication
`WO 2015/179571
`Hertz
`U.S. Patent 5,718,662
`U.S. Patent Publication No.
`2011/0172735
`U.S. Patent Application Publication
`2006/0187607
`BTL Medical Technologies s.r.o.
`BTL Medical Technologies s.r.o.
`Allergan, Inc., Allergan Limited,
`Allergan USA, Inc., Zeltiq Aesthetics,
`Inc., Zeltiq Ireland Unlimited
`Company, and Remed Co. Ltd.
`U.S. Patent 7,591,776
`Person Of Ordinary Skill In The Art
`Tesla
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`’576 patent
`BTL
`Burnett ’585
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`Burnett ’821
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`EMS
`Errico
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`Hz
`Jalinous
`Johari
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`Mo
`
`Patent Owner
`Patentee
`Petitioners
`
`Phillips
`POSITA
`T
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`PGR2021-00025
`Patent 10,695,576 B2
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`I.
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`INTRODUCTION
`The ’576 patent, which issued under expedited consideration, adds nothing
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`inventive to the field of magnetic stimulation to cause muscle contraction. The
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`patent, which recites only device claims, merely recycles well-known components
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`of conventional devices, with broad ranges of values for well-known magnetic field
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`parameters used in such devices. The “Burnett ’585” patent (Grounds 1-2),
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`“Magstim” publication (Grounds 3-5), and the other references presented here show
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`this. Patent Owner’s attempt to monopolize obvious combinations of components
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`or parameters for magnetic stimulation devices fails under Section 103.
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`The Board should grant review and hold the claims obvious.
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`II. THE ’576 PATENT
`The ’576 patent purports to claim magnetic devices for aesthetics, or “toning
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`a muscle.” EX1003, 108:13. Its earliest claimed priority date is May 10, 2016.1
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`EX1003, 1:37-53. The patent issued on June 30, 2020, and recites 30 device claims.
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`Four claims are independent: claims 1, 8, 16, and 23.
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`The independent claims recite well-known interdependent parameters for
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`specifying a time-varying magnetic field, each of which spans several orders of
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`magnitude:
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`• 0.5 to 7 Tesla (“T”) magnetic flux density (claims 8, 16, 23)
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`1 Petitioners do not concede this priority date.
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`PGR2021-00025
`Patent 10,695,576 B2
`• 1 to 300 kT/s maximal magnetic flux density derivative (claim 23), or 2 to
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`200 kT/s maximal magnetic flux density derivative (claim 16)
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`• 3 μs to 1 ms impulse duration (claims 1, 16, 23)
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`• 1 to 300 Hz pulse repetition rate (claims 8, 11), 10 to 45 Hz pulse repetition
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`rate (claim 13), 30 to 60 Hz pulse repetition rate (claim 13), or 1 to 80 Hz
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`(claim 16)
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`• 1 nH to 50 mH coil inductance (claim 1), or 500 nH to 1 mH coil inductance
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`(claims 8, 23)
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`The specification acknowledges that these parameters are interdependent but
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`provides no detailed guidance as to how they work in concert to achieve muscle
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`contraction much less “toning.” The patent discloses no specific working example,
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`test result, or example of any combination of these parameters that might guide a
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`skilled artisan in choosing among these parameters or in utilizing the entire claimed
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`ranges. See EX1023, ¶¶ 75-98.
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`The patent was reviewed under the Track One program. EX1010, 3, 20-21.
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`During this expedited review, Applicant overwhelmed the Examiner with hundreds
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`of prior art documents, but the claims never received any prior-art rejection.
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`EX1010, 32-63. Applicant amended the claims prior to any action by the Examiner,
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`canceling both original claims and adding 30 new claims. EX1010, 6-17. The
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`application did not receive any substantive rejections. Furthermore, the Examiner
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`PGR2021-00025
`Patent 10,695,576 B2
`did not review 35 of the prior art documents because Applicant failed to provide a
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`copy or a proper date. EX1010, 52-61. The Examiner allowed the claims presented
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`in the preliminary amendment without a single rejection. EX1010, 22-31. See
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`EX1023, 99-101.
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`III. THIS PETITION MEETS PGR REQUIREMENTS (37 C.F.R. § 42.204)
`Standing (37 C.F.R. § 42.204(a))
`A.
`Petitioners certify that the ’576 patent is eligible for PGR. The patent’s
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`effective filing date is after March 16, 2013, and this Petition is being filed within
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`nine months of the patent’s June 30, 2020 issuance. See 35 U.S.C. § 321(c). Further,
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`Petitioners are not barred or estopped from requesting this PGR.
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`B.
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`Ground
`1
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`2
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`3
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`4
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`5
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`The Challenged Claims and Statutory Grounds (37 C.F.R.
`§ 42.204(b)(1), (2), (4), & (5))
`Claims
`1-23, 25-30
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`Basis for Rejection
`§ 103: Burnett ’585 in view of Burnett ’821 and
`Johari
`§ 103: Burnett ’585 in view of Burnett ’821,
`Johari, and Errico
`§ 103: Magstim in view of Jalinous, Porcari, and
`1-15, 23, 25, 28-
`Phillips
`29
`16-22, 26-27, 30 § 103: Magstim in view of Jalinous, Porcari,
`Phillips, and Mo
`§ 103: Magstim in view of Jalinous, Porcari,
`Phillips, and Errico
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`24
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`24
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`As demonstrated in Section V.A below:
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`• Each reference qualifies as prior art under § 102(a)(1).
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`Patent 10,695,576 B2
`• Burnett ’585, Johari, Burnett ’821, Jalinous, Phillips, Mo, and Errico
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`also qualify as prior art under § 102(a)(2).
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`Magstim, Johari, Porcari, and Phillips were not before the Examiner during
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`prosecution. Although Burnett ’585, Burnett ’821, Jalinous, Mo, and Errico were,
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`none were applied against the claims or discussed, which weighs against § 325(d)
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`denial.2 See Bowtech, Inc. v. MCP IP, LLC, IPR2019-00379, Paper 14 at 18 (PTAB
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`July 3, 2019) (distinguishing art the Examiner actually considered from art merely
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`cited to the Examiner).
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`C. Claim Construction (37 C.F.R. § 42.204(b)(3))
`The term “control unit” is an indefinite means-plus-function term, as
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`explained in Petitioners’ related petition challenging the ’576 patent. To the extent
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`the term is not held indefinite, the grounds in Section V demonstrate that the “control
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`unit” claims would have been unpatentable under Section 103.
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`The term “toning” (“toned”) should be given its plain and ordinary meaning
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`as confirmed in the patent: an enhanced visual appearance of a body region or
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`muscle caused by induced muscle contractions that strengthen, firm, volumize, or
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`2 Burnett ’585 and Burnett ’821 were applied during prosecution of
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`applications related to the ’576 patent, but they were not distinguished in ways
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`relevant to the challenges raised here.
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`Patent 10,695,576 B2
`tighten the muscle. See, e.g., EX1003, Abstract, 2:33-36, 3:57-62, 23:28-37. As the
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`specification explains, “muscle toning” is an effect where “[t]he muscle may gain
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`strength without adipose tissue reduction,” and this “effect may be known as muscle
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`strengthening, muscle toning or muscle firming.” EX1003, 25:37-39.
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`For purposes of this proceeding, the remaining claim terms should be
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`interpreted consistent with their ordinary and customary meaning, unless expressly
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`defined in the specification. See, e.g., EX1003, 4:64-6:24. Petitioners do not waive,
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`and expressly reserve, all arguments and evidence it may raise in other proceedings
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`regarding claim construction and scope.3 See EX1023, ¶¶ 69-74.
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`POSITA
`D.
`A POSITA at the time of the alleged invention would include a person (or a
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`group of people) familiar with the design, development, and use of devices that apply
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`electrical energy directly, or indirectly via magnetic fields, to the body to stimulate
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`biological tissue (e.g., brains, spinal cords, nerves, or muscles). The skilled artisan’s
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`group would include: (i) a person with at least a bachelor’s degree in electrical
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`engineering, biomedical engineering, physics, or related field of study, and at least
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`two years’ experience in academia or industry researching, designing, or developing
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`3 Petitioners note that the ITC proceeding involving the ’576 and other
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`patents is still in the early stages.
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`Patent 10,695,576 B2
`such devices, and (ii) a medical doctor, healthcare provider, researcher, or other
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`person having a degree in medicine, physiology, neuroscience, kinesiology, physical
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`therapy, biomechanics, or a related discipline and two or more years of using,
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`researching, designing, or developing such devices. EX1023, ¶¶ 1-26, 65-68.
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`The prior art cited during prosecution reflects this level of skill. See Okajima
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`v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
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`IV. MUSCLE STIMULATION DEVICES WERE WELL-KNOWN IN
`THE ART
`A. The Principles Of Bioelectricity For Inducing Muscle Contraction
`Were Well Understood
`At its core, muscle contraction takes advantage of the body’s bioelectricity—
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`the way in which cells and tissues use electricity to communicate. The artificial
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`application of energy to the nerves of the muscle tissue can achieve a desired
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`therapeutic effect by depolarizing a cell membrane, causing the nerve to “fire” and
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`thereby contract the muscle. See, e.g., EX1098, 3-4; see also EX1068, 1:7-48;
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`EX1056, 847. This mechanism for inducing current in biological tissues was well
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`understood by the time of the alleged invention:
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`In the context of electrical stimulation of the anatomy, certain
`parts of the anatomy (e.g., nerves, tissue, muscle, brain) act as a
`conductor and carry electric current when an electric field is
`presented. The electric field may be presented to these parts of
`the anatomy transcutaneously by applying a time varying (e.g.,
`pulsed) magnetic field to the portion of the body. . . . An impulse
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`of current is then propagated along the axon membrane which
`transmits information to other neurons via modulation of
`neurotransmitters.
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`EX1067, 4:22-37; EX1023, ¶¶ 31-34, 50-52.
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`B. Using Magnetic And Electrical Stimulation For Muscle
`Contraction Was Well-Known
`Well before the ’576 patent, it was known that applying repeated pulses of
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`energy to a nerve can cause sustained muscle contractions. EX1051, 39; EX1098,
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`3-4. Two similar modalities were used to induce current in biological tissues:
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`magnetic stimulation and electrical stimulation. Whereas electrical stimulation
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`applies current directly to the body, magnetic stimulation—in particular, the use of
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`“time-varying” magnetic fields—induces a current indirectly by being applied on or
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`near a body region. See EX1069, ¶ [0003]; EX1098, 3-4; EX1051, 39; EX1054, 3,
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`5.
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`Regardless whether the current is applied directly or indirectly, the “dose” of
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`stimulation to the body is the same; a neuron cannot distinguish the source of its
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`current. EX1023, ¶ 42, 53-56. Thus, artisans used techniques from the two
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`modalities interchangeably. EX1023, ¶¶ 42, 53-57; e.g., EX1051, 39 (“The cellular
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`mechanism of stimulation is the same for both [electrical and magnetic]
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`techniques.”); EX1098, 3 (same).
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`Moreover, devices for both modalities were well-known. And, these devices
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`used