`
`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 IPR2021-00312
`U.S. PATENT NO. 10,478,634 B2
`Title: Aesthetic method of biological structure treatment by magnetic field
`__________________
`PETITION FOR INTER PARTES REVIEW
`Pursuant to 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42.100 et seq.
`
`
`

`

`TABLE OF CONTENTS
`
`
`PAGE
`
`2.
`
`3.
`
`6.
`
`7.
`
`INTRODUCTION .......................................................................................... 1
`THE ’634 PATENT ........................................................................................ 1
`37 C.F.R. § 42.104 REQUIREMENTS .......................................................... 1
`A.
`Standing, Claims, And Grounds ........................................................... 1
`B.
`Claim Construction............................................................................... 2
`C.
`POSITA ................................................................................................ 3
`IV. MUSCLE STIMULATION DEVICES WERE WELL-KNOWN ................ 4
`A.
`The Principles Of Bioelectricity For Inducing Muscle
`Contraction Were Well Understood ..................................................... 4
`B. Magnetic And Electrical Stimulation For Muscle Contraction
`Were Well-Known ............................................................................... 4
`Stimulation Devices For Toning Muscle Were Well-Known .............. 7
`C.
`V. Grounds 1-6: The Challenged Claims Are Obvious ...................................... 8
`A.
`REFERENCES ..................................................................................... 8
`1.
`Burnett ’585: Augmenting Abdominal Muscle Size With
`Magnetic Stimulation Device Coupled To Body ....................... 8
`Burnett ’821: Integrating Cooling Into Magnetic
`Stimulation Device Coils ........................................................... 9
`Johari: Ramped Pulse Sequences At Different Repetition
`Rates ........................................................................................... 9
`Anderson: Skin Cooling Element ............................................. 9
`4.
`5. Magstim: Magnetic Stimulation Devices For Muscle
`Training .................................................................................... 10
`Porcari: Electrical Stimulation For Toning Abdominal
`Muscles .................................................................................... 11
`Jalinous: Magnetic Stimulation Using Two Coils
`(Applicators) ............................................................................ 11
`Phillips: Magnetic Coil Liquid Cooling System ...................... 12
`8.
`B. Ground 1: Claims 1-2, 4, And 6-7 Are Obvious In View Of
`Burnett ’585 ........................................................................................ 13
`-i-
`
`
`
`I.
`II.
`III.
`
`
`
`
`
`

`

`TABLE OF CONTENTS
`(Continued)
`
`PAGE
`
`1.
`2.
`3.
`4.
`
`Independent Claim 1 ................................................................ 13
`Claim 2 (repetitive contraction, muscle group) ....................... 15
`Claim 4 ..................................................................................... 16
`Claim 6 (second applicator with coil, simultaneous time-
`varying magnetic field) ............................................................ 16
`Claim 7 (inductance) ................................................................ 17
`5.
`C. Ground 2: Claims 3, 5, 8-14, And 23-30 Are Obvious In View
`Of Burnett ’585 And Johari ................................................................ 17
`1.
`Claim 3 (bursts comprising first/second time periods) ............ 17
`2.
`Claim 5 (duty cycle) ................................................................. 19
`3.
`Claim 8 (repetition rates) ......................................................... 20
`4.
`Independent Claim 9 ................................................................ 24
`5.
`Claim 10 (repetition rates) ....................................................... 27
`6.
`Claim 11 (number of bursts) .................................................... 27
`7.
`Claim 12 (tetanus contraction) ................................................. 27
`8.
`Claim 13 (relaxation period) .................................................... 28
`9.
`Claim 14 (number of bursts) .................................................... 28
`10.
`Independent Claim 23 .............................................................. 28
`11. Claims 24 (abdominal muscles) ............................................... 31
`12. Claim 25 (gluteus muscles) ...................................................... 32
`13. Claim 26 ................................................................................... 32
`14. Claim 27 (leg, arm muscles) .................................................... 32
`15. Claim 28 (mutually tilted planes) ............................................ 33
`16. Claim 29 (arm, shoulder, and chest muscles) .......................... 34
`17. Claim 30 (adjustable flexible belt) ........................................... 34
`D. Ground 3: Claims 15-22 Are Obvious In View Of Burnett ’585,
`Johari, And Burnett ’821. ................................................................... 34
`
`-ii-
`
`
`
`
`
`
`
`
`
`

`

`E.
`
`F.
`
`TABLE OF CONTENTS
`(Continued)
`
`PAGE
`
`Claim 15 (core area) ................................................................. 34
`1.
`Claim 16 ................................................................................... 35
`2.
`Claim 17 (number of bursts) .................................................... 37
`3.
`Claim 18 ................................................................................... 37
`4.
`Claim 19 (casing and handle) .................................................. 38
`5.
`Claim 20 (magnetic flux density derivative) ........................... 38
`6.
`Claim 21 (thermal treatment) ................................................... 38
`7.
`Claim 22 (cooling element temperature) ................................. 40
`8.
`Ground 4: Claims 21-22 Are Obvious In View of Burnett ’585,
`Burnett ’821, Johari, and Anderson ................................................... 40
`1.
`Claim 21 (thermal treatment) ................................................... 40
`2.
`Claim 22 (cooling element temperature) ................................. 42
`Ground 5: Claims 1-15 And 23-30 Are Obvious In View Of
`Magstim, Jalinous, And Porcari ......................................................... 42
`1.
`Independent Claim 1 ................................................................ 46
`2.
`Claim 2 (repetitive contraction, muscle group) (96:1-9) ......... 51
`3.
`Claim 3 (bursts comprising first/second time periods)
`(96:10-18) ................................................................................. 52
`Claim 4 ..................................................................................... 53
`Claim 5 (duty cycle) ................................................................. 53
`Claim 6 (second applicator with coil, simultaneous time-
`varying magnetic field) ............................................................ 54
`Claim 7 (inductance) ................................................................ 56
`7.
`Claim 8 (repetition rates) ......................................................... 57
`8.
`Independent Claims 9 And 23.................................................. 60
`9.
`10. Claim 10 (repetition rates) ....................................................... 66
`11. Claim 11 (number of bursts) .................................................... 66
`12. Claim 12 (tetanus contraction) ................................................. 66
`-iii-
`
`
`4.
`5.
`6.
`
`
`
`
`
`
`
`

`

`TABLE OF CONTENTS
`(Continued)
`
`PAGE
`
`
`
`13. Claim 13 (relaxation period) .................................................... 67
`14. Claim 14 (number of bursts) .................................................... 67
`15. Claim 15 (core area) ................................................................. 67
`16. Claims 24 (abdominal muscles) ............................................... 67
`17. Claim 25 (gluteus muscles) ...................................................... 67
`18. Claim 26 ................................................................................... 68
`19. Claim 27 (leg, arm muscles) .................................................... 68
`20. Claim 28 (mutually tilted planes) ............................................ 69
`21. Claim 29 (arm, shoulder, and chest muscles) .......................... 69
`22. Claim 30 (adjustable flexible belt) ........................................... 69
`G. Ground 6: Claims 16-22 Are Obvious In View Of Magstim,
`Jalinous, Porcari, And Phillips. .......................................................... 69
`1.
`Claim 16 ................................................................................... 71
`2.
`Claim 17 (number of bursts) .................................................... 73
`3.
`Claim 18 ................................................................................... 73
`4.
`Claim 19 (casing and handle) .................................................. 74
`5.
`Claim 20 (magnetic flux density derivative) ........................... 74
`6.
`Claim 21 (thermal treatment) ................................................... 75
`7.
`Claim 22 (cooling element temperature) ................................. 77
`INSTITUTION IS WARRANTED .............................................................. 77
`VI.
`VII. CLAIM LISTING ......................................................................................... 80
`VIII. MANDATORY NOTICES .......................................................................... 86
`A.
`Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) ................................. 86
`B.
`Related Matters (37 C.F.R. § 42.8(b)(2)) ........................................... 86
`C.
`Identification Of Service Information (37 C.F.R. § 42.8(b)(3)
`And (b)(4)) ......................................................................................... 88
`
`
`
`
`
`-iv-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF EXHIBITS
`
`TITLE
`
`
`
`EXHIBIT
`NO.
`1001
`
`Reserved
`
`1002
`
`Reserved
`
`1003
`
`Reserved
`
`1004
`
`Reserved
`
`1005
`
`Reserved
`
`1006
`
`Reserved
`
`1007
`
`U.S. Patent No. 10,478,634 (“ʼ634 patent”)
`
`1008
`
`Reserved
`
`1009
`
`Reserved
`
`1010
`
`Reserved
`
`1011
`
`Reserved
`
`1012
`
`Reserved
`
`1013
`
`Reserved
`
`
`
`
`
`-i-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF EXHIBITS
`(Continued)
`
`EXHIBIT
`NO.
`1014
`
`TITLE
`
`Abbreviated File History of the ʼ634 patent
`
`1015
`
`Chris Hovey BSc & Reza Jalinous PhD, The Guide to Magnetic
`Stimulation (“Magstim”)
`
`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
`
`John P. Porcari et al., Effects of Electrical Muscle Stimulation on
`Body Composition, Muscle Strength, and Physical Appearance,
`16(2) J. Strength & Conditioning Research 165 (2002) (“Porcari”)
`
`John P. Porcari et al., The Effects of Neuromuscular Electrical
`Stimulation Training on Abdominal Strength, Endurance, and
`Selected Anthropometric Measures, 4 J. Sports Sci. & Med. 66
`(2005) (“Porcari 2005”)
`
`1021
`
`U.S. Patent No. 8,834,547 (“Anderson”)
`
`1022
`
`Reserved
`
`1023
`
`Declaration of Dr. Pedro Irazoqui
`
`1024
`
`Declaration of Maria P. Garcia
`
`
`
`
`
`-ii-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`U.S. Patent Application Publication No. 2011/0190569
`(“Simon ʼ569”)
`
`U.S. Patent Application Publication No. 2011/0152967
`(“Simon ʼ967”)
`
`U.S. Patent Application Publication No. 2011/0125203
`(“Simon ʼ203”)
`
`U.S. Patent Application Publication No. 2011/0046432
`(“Simon ʼ432”)
`
`EXHIBIT
`NO.
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`U.S. Patent No. 9,089,719 (“Simon ʼ719”)
`
`1030
`
`U.S. Patent No. 9,037,247 (“Simon ʼ247”)
`
`1031
`
`U.S. Patent No. 8,868,177 (“Simon ʼ177”)
`
`1032
`
`File History of U.S. Patent Application No. 12/859,568 (excerpts)
`
`1033
`
`File History of U.S. Patent Application No. 12/964,050 (excerpts)
`
`1034
`
`File History of U.S. Patent Application No. 13/005,005 (excerpts)
`
`1035
`
`File History of U.S. Patent Application No. 13/024,727 (excerpts)
`
`
`
`
`
`-iii-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`D. Suarez-Bagnasco et al., The Excitation Functional for Magnetic
`Stimulation of Fibers, 32nd Ann. Int’l Conf. of the IEEE EMBS,
`4829-33 (2010)
`
`Zhi-De Deng et al., Electric field depth-focality tradeoff in
`transcranial magnetic stimulation: simulation comparison of 50 coil
`designs, Brain Stimulation, 6(1):1-13 (2013)
`
`Zhi-De Deng, Electromagnetic Field Modeling of Transcranial
`Electric and Magnetic Stimulation: Targeting, Individualization,
`and Safety of Convulsive and Subconvulsive Applications (2013)
`(Ph.D. dissertation, Columbia University)
`
`U.S. Patent Application Publication No. 2003/0158585
`(“Burnett ’585”)
`
`U.S. Patent Application Publication No. 2012/0302821
`(“Burnett ’821”)
`
`EXHIBIT
`NO.
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`U.S. Patent Application Publication No. 2011/0172735 (“Johari”)
`
`1042
`
`Reserved
`
`1043
`
`Reserved
`
`1044
`
`Reserved
`
`
`
`
`
`-iv-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`EXHIBIT
`NO.
`1045
`
`Reserved
`
`1046
`
`Reserved
`
`1047
`
`Reserved
`
`1048
`
`TESLA Stym – FMS – Functional Magnetic Stimulation Website
`(2013)
`
`1049
`
`Iskra Medical, TESLA Stym Brochure (2013)
`
`1050
`
`1051
`
`1052
`
`1053
`
`Struppler et al., Modulatory effect of repetitive peripheral magnetic
`stimulation on skeletal muscle tone in healthy subjects: stabilization
`of the elbow joint, Experimental Brain Research, 157:59-66 (2004)
`
`Behrens et al., Repetitive peripheral magnetic stimulation (15 hz
`rpms) of the human soleus muscle did not affect spinal excitability,
`Journal of Sports Science and Medicine, 10:39-44 (2011)
`
`Barker et al., An Introduction to the Basic Principles of Magnetic
`Nerve Stimulation, Journal of Clinical Neurophysiology, 8(1):26-37
`(1991)
`
`Szecsi et al., Force-pain relationship in functional magnetic and
`electrical stimulation of subjects with paresis and preserved
`sensation, Clinical Neurophysiology, 121:1589-1597 (2010)
`
`
`
`
`
`-v-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`Geddes, History of Magnetic Stimulation of the Nervous System,
`8(1) Journal of Clinical Neurophysiology (1991)
`
`EXHIBIT
`NO.
`1054
`
`1055
`
`Benton et al., Functional Electrical Stimulation – A Practical
`Clinical Guide, Second Edition, The Professional Staff Association
`of the Rancho Los Amigos Hospital, Inc. (1981) (excerpt)
`
`1056 Man et al., Magnetic stimulation for the measurement of respiratory
`and skeletal muscle function, European Respiratory Journal, 24:846-
`860 (2004)
`
`1057
`
`Abulhasan et al., Peripheral Electrical and Magnetic Stimulation to
`Augment Resistance Training, Journal of Functional Morphology
`and Kinesiology, 1(3):328-342 (2016)
`
`1058 Ward et al., Russian Electrical Stimulation: The Early Experiments,
`82(10) Physical Therapy (2002)
`
`1059
`
`510(k) Summary, No. K163165, AM-100 (2017)
`
`1060
`
`510(k) Summary, No. K030708, Slendertone FLEX (2003)
`
`1061
`
`510(k) Summary, No. K062439, Powertone (2007)
`
`1062
`
`510(k) Summary, No. K131291, Torc Body (2013)
`
`1063
`
`ITC Complaint, Investigation No. 337-TA-1219
`
`
`
`
`
`-vi-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF EXHIBITS
`(Continued)
`
`EXHIBIT
`NO.
`1064
`
`TITLE
`
`U.S. Patent No. 5,766,124 (“Polson”)
`
`1065
`
`U.S. Patent Application Publication No. 2014/0046423 (“Rajguru”)
`
`1066
`
`Reserved
`
`1067
`
`U.S. Patent No. 10,413,745 (“Riehl”)
`
`1068
`
`U.S. Patent No. 5,725,471 (“Davey”)
`
`1069
`
`1070
`
`1071
`
`1072
`
`U.S. Patent Application Publication No. 2014/0148870
`(“Burnett ʼ870”)
`
`U.S. Patent Application Publication No. 2010/0145399
`(“Johari ʼ399”)
`
`Binder-MacLeod et al., Use of a catchlike property of human
`skeletal muscle to reduce fatigue, Muscle & Nerve, 14(9):850-857
`(1991)
`
`Verges et al., Comparison of electrical and magnetic stimulations to
`assess quadriceps muscle function, Journal of Applied Physiology,
`106(2):701-710 (2009)
`
`1073
`
`U.S. Patent Application Publication No. 2016/0129274 (“Park”)
`
`1074
`
`U.S. Patent No. 5,181,902 (“Erickson”)
`
`
`
`
`
`-vii-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`U.S. Patent Application Publication No. 2010/0331603 (“Szecsi”)
`
`EXHIBIT
`NO.
`1075
`
`1076
`
`U.S. Patent Application Publication No. 2014/0277219 (“Nanda”)
`
`1077
`
`Schaefer et al., Review of Patient Safety in Time-Varying Gradient
`Fields, Journal of Magnetic Resonance Imaging, 12:20-29 (2000)
`
`1078
`
`Reserved
`
`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
`to enhance their strength (2016)
`
`Belyaev, Andrey Gennadievich, Effect of magnetic stimulation on
`the strength capacity of skeletal muscles (2015)
`
`Belyaev, Andrey Gennadievich, Effect of magnetic stimulation on
`the strength capacity of skeletal muscles (2015), certified English
`translation of EX1083
`
`1085
`
`CV of Pedro Irazoqui
`
`
`
`
`
`-viii-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF EXHIBITS
`(Continued)
`
`EXHIBIT
`NO.
`1086 Mogyoros et al., Strength-duration properties of human peripheral
`nerve, Brain 119(2):439-447 (1996)
`
`TITLE
`
`1087
`
`1088
`
`1089
`
`Kolin et al., Stimulation of Irritable Tissues by Means of an
`Alternating Magnetic Field (1959)
`
`Belyaev, Andrey Gennadievich, Effect of magnetic stimulation on
`the strength capacity of skeletal muscles (2015), author’s summary
`of EX1083
`
`Belyaev, Andrey Gennadievich, Effect of magnetic stimulation on
`the strength capacity of skeletal muscles (2015), author’s summary
`of EX1083, certified English translation of EX1088
`
`1090
`
`Reserved
`
`1091
`
`1092
`
`Alain-Yvan Bélanger, Therapeutic Electrophysical Agents –
`Evidence Behind Practice, Third Edition, Wolters Kluwer (2015)
`(excerpt)
`
`Declaration of Christopher Buxton (regarding the authenticity of
`EX1048-EX1063, EX1071-EX1072, EX1077-EX1078, EX1086-
`EX1087, EX1084, EX1089, EX1098)
`
`1093
`
`Declaration of Vladislav Ugryumov (authenticating EX1083,
`EX1088)
`
`1094
`
`Reserved
`
`
`
`
`
`-ix-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`BTL’s Response to Respondent’s Motion To Compel Corporate
`Deposition Testimony (Motion No. 1219-002), Investigation No.
`337-TA-1219
`
`EXHIBIT
`NO.
`1095
`
`1096
`
`Reserved
`
`1097
`
`U.S. Patent Application Publication No. 2015/0157873
`(“Sokolowski”)
`
`1098
`
`Reserved
`
`1099
`
`1100
`
`Thompson, Inductance Calculation Techniques – Part I: Classical
`Methods, in Power Control and Intelligent Motion, vol. 25, no. 12,
`December 1999, pp. 40-45
`
`Thompson, Inductance Calculation Techniques – Part II:
`Approximations and Handbook Methods, in Power Control and
`Intelligent Motion, 1999
`
`1101
`
`Reserved
`
`1102
`
`Reserved
`
`1103
`
`Reserved
`
`1104
`
`Reserved
`
`
`
`
`
`-x-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`EXHIBIT
`NO.
`1105
`
`Reserved
`
`1106
`
`Reserved
`
`
`
`
`
`-ii-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`TABLE OF ABBREVIATIONS
`
`Abbreviation
`
`’634 patent
`Anderson
`BTL
`Burnett ’585
`
`Burnett ’821
`
`H
`Hz
`Jalinous
`Johari
`
`Patent Owner
`Petitioners
`
`Porcari
`
`Phillips
`POSITA
`T
`
`Term
`U.S. Patent No. 10,478,634
`U.S. Patent No. 8,834,547
`BTL Industries, Inc.
`U.S. Patent Publication No.
`2003/0158585
`U.S. Patent Publication No.
`2012/0302821
`Henry
`Hertz
`U.S. Patent 5,718,662
`U.S. Patent Publication No.
`2011/0172735
`BTL Medical Technologies S.R.O.
`Allergan, Inc., Allergan Limited,
`Allergan USA, Inc., Zeltiq Aesthetics,
`Inc., Zeltiq Ireland Unlimited
`Company, and Remed Co. Ltd.
`John P. Porcari et al., Effects of
`Electrical Muscle Stimulation on Body
`Composition, Muscle Strength, and
`Physical Appearance, 16(2) J. Strength
`& Conditioning Research 165 (2002)
`U.S. Patent 7,591,776
`Person Of Ordinary Skill In The Art
`Tesla
`
`
`
`
`
`
`
`
`
`
`
`-i-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`
`I.
`
`INTRODUCTION
`The ’634 patent, which received Track One consideration, merely recycles
`
`well-known magnetic-stimulation components and parameters
`
`in obvious
`
`combinations. As the representative references presented here show, the Board
`
`should institute and hold the claims unpatentable.
`
`II. THE ’634 PATENT
`The patent, asserting a July 1, 2015 priority date, purports to claim methods
`
`for “using time-varying magnetic fields” for toning muscle or body shaping by
`
`inducing muscle contractions. 1 EX1007, 95:52-53; EX1023, ¶¶ 71-86. The
`
`Applicant cited nearly 200 prior-art references without providing any guidance about
`
`them. EX1014, 37-39, 110-122, 198-199; EX1023, ¶¶ 87-89.
`
`III. 37 C.F.R. § 42.104 REQUIREMENTS
`Standing, Claims, And Grounds
`A.
`Petitioners are not barred or estopped from requesting IPR, and this Petition
`
`is timely. See No. 1-19-cv-02356 (D. Del.) (served Jan. 7, 2020). Petitioners
`
`challenge claims 1-30, supported by Dr. Irazoqui’s declaration (EX1023):
`
`Ground
`1
`2
`
`Basis
`Claims
`§ 103(a) based on Burnett ’585
`1-2, 4, 6-7
`3, 5, 8-14, 23-30 § 103(a) based on Burnett ’585 in view of Johari
`
`
`
`
`1 Petitioners do not concede this priority date.
`
`
`
`
`
`-1-
`
`
`
`

`

`Ground
`3
`
`4
`
`5
`
`6
`
`Claims
`15-22
`
`21-22
`
`1-15, 23-30
`
`16-22
`
`IPR2021-00312
`Patent 10,478,634 B2
`Basis
`§ 103(a) based on Burnett ’585 in view of
`Burnett ’821 and Johari
`§ 103(a) based on Burnett ’585 in view of
`Burnett ’821, Johari, and Anderson
`§ 103(a) based on Magstim in view of Jalinous
`and Porcari
`§ 103(a) based on Magstim in view of Jalinous
`and Porcari and Phillips
`
`
`
`B. Claim Construction
`“Toning” should be given its plain and ordinary meaning as confirmed in the
`
`patent: an enhanced visual appearance of a body region or muscle caused by induced
`
`muscle contractions that strengthen, firm, volumize, or tighten the muscle. E.g.,
`
`EX1007, Abstract, 2:32-35, 3:55-60, 17:67-18:3, 19:43-20:2; EX1023, ¶¶ 66-69.
`
`“[M]uscle toning” is an effect where “[t]he muscle may gain strength without
`
`adipose tissue reduction,” and this “effect may be known as muscle strengthening,
`
`muscle toning or muscle firming.” EX1007, 19:61-2:2. Body shaping is also said
`
`to be achieved by muscle contraction similarly to toning. EX1007, 19:55-60, 23:46-
`
`57, 30:45-50, 97:27-53.
`
`In this proceeding, the remaining terms should be interpreted consistent with
`
`their ordinary and customary meaning, unless expressly defined in the specification.
`
`EX1007, 4:65-6:7. Petitioners do not waive, and expressly reserve, all arguments
`
`
`
`
`
`-2-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`and evidence they may raise in other proceedings regarding claim construction and
`
`scope.2
`
`POSITA
`C.
`A POSITA at the time of the alleged invention would include a person (or a
`
`group of people) familiar with the design, development, and use of devices that apply
`
`electrical energy directly, or indirectly via magnetic fields, to the body to stimulate
`
`biological tissue (e.g., brains, spinal cords, nerves, or muscles). The skilled artisan’s
`
`group would include: (i) a person with at least a bachelor’s degree in electrical
`
`engineering, biomedical engineering, physics, or related field of study, and at least
`
`two years’ experience in academia or industry researching, designing, or developing
`
`such devices, and (ii) a medical doctor, healthcare provider, researcher, or other
`
`person having a degree in medicine, physiology, neuroscience, kinesiology, physical
`
`therapy, biomechanics, or a related discipline and two or more years of using,
`
`researching, designing, or developing such devices. EX1023, ¶¶ 62-63.
`
`
`
`
`2 Petitioners note that the ITC proceeding involving the ’634 and other
`
`patents is still in the early stages.
`
`
`
`
`
`-3-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`IV. MUSCLE STIMULATION DEVICES WERE WELL-KNOWN
`A. The Principles Of Bioelectricity For Inducing Muscle Contraction
`Were Well Understood
`Muscle contraction takes advantage of the body’s bioelectricity—the way in
`
`which cells and tissues use electricity to communicate. Artificial application of
`
`energy to the nerves of the muscle tissue can achieve a desired therapeutic effect by
`
`depolarizing a cell membrane, causing the nerve to “fire” and thereby contract the
`
`muscle. E.g., EX1052, 26-27; see also EX1068, 1:7-48; EX1056, 847. This
`
`mechanism for inducing current in biological tissues was well understood by the
`
`time of the alleged invention:
`
`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 of current is then propagated along the
`axon membrane which transmits information to other neurons via
`modulation of neurotransmitters.
`
`EX1067, 4:22-37. See EX1023, ¶¶ 27-46.
`
`B. Magnetic And Electrical Stimulation For Muscle Contraction
`Were Well-Known
`Well before the ’634 patent, it was known that applying repeated pulses of
`
`energy to a nerve can cause sustained muscle contractions. EX1051, 39; EX1052,
`
`
`
`
`
`-4-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`26-27. Two similar modalities were used to induce current in biological tissues:
`
`magnetic and electrical stimulation. Whereas electrical applies current directly to
`
`the body, magnetic—in particular, the use of “time-varying” magnetic fields—
`
`induces a current indirectly through application on or near a body region. See
`
`EX1069, ¶ [0003]; EX1052, 27-28; EX1051, 39; EX1054, 3, 5.
`
`Regardless which modality, the stimulation “dose” is the same; a neuron
`
`cannot distinguish the current’s source. EX1023, ¶¶ 50-52. Thus, artisans used
`
`techniques from the two modalities interchangeably. E.g., EX1051, 39 (“cellular
`
`mechanism” is “the same” for electrical and magnetic techniques); EX1052, 27
`
`(same).
`
`Moreover, devices for both modalities were well-known, and they used the
`
`same or similar operating parameters. E.g., EX1072, 702; EX1050, 59; EX1057,
`
`330. These include: intensity of the energy stimulus (which, for magnetic
`
`stimulation, includes magnetic flux density, in Tesla, and magnetic flux density
`
`derivative, in kT/s); duration of a pulse, measured in units of time; pulse repetition
`
`rate, in hertz; number of pulses in a group (“train”); and the time from one train to
`
`the next (described in the ’634 patent as a “burst”), in units of time. EX1015, 11-
`
`12, 43; EX1007, 16:36-52. Artisans used knowledge about the two modalities and
`
`the parameters interchangeably, and further understood these parameters are
`
`interrelated, e.g., shorter impulses require a higher magnetic field or current strength
`
`
`
`
`
`-5-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`than longer pulses to induce muscle contractions, and large muscles require more
`
`energy to stimulate than small muscles. EX1055, 16. Artisans also understood that
`
`sustained muscle contraction of human skeletal muscles occurs with repeated pulses
`
`between 30 and 80 Hz. EX1091, 33.
`
`Numerous prior art references discuss the use of magnetic or electrical
`
`stimulation to contract muscles for a variety of applications. E.g., EX1052, 27-28
`
`(development of magnetic nerve stimulation); EX1053, 1589; EX1050, 5. These
`
`included muscle rehabilitation, strengthening of pelvic floor muscles (for
`
`incontinence treatment) and respiratory muscles, weight loss, pain management,
`
`muscle-atrophy prevention, and osteoporosis and muscle-cramp treatments.
`
`EX1068, 4:16-59; EX1019, 165; EX1015, 39; EX1049, 1, 3; EX1065, ¶ [0121];
`
`EX1056, 853; EX1050, 65-66; EX1051, 43.
`
`It was well-known that magnetic stimulation offered benefits important for
`
`large-muscle contractions. EX1023, ¶¶ 53-57. Magnetic stimulation is not applied
`
`directly to the skin and is “ouchless,” unlike electrical stimulation that often causes
`
`pain and irritation. EX1054, 3; see also EX1068, 1:27-36; EX1056, 847. Magnetic
`
`stimulation can therefore use higher “power levels,” reaching deeper muscle layers.
`
`EX1015, 12-13.
`
`
`
`
`
`-6-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`Stimulation Devices For Toning Muscle Were Well-Known
`C.
`As early as the 1970s, muscle stimulation was used for aesthetic, toning
`
`treatments. EX1058, 1021; EX1084, 25-26. Russian scientists were among the first
`
`to advocate for externally stimulating muscles to “increas[e] muscle force … of elite
`
`athletes.” EX1058, 1021 (describing 1977 presentation). Likewise, by 2001, FDA
`
`had approved an over-the-counter device, Slendertone FLEX, for “improvement of
`
`abdominal muscle tone” and “strengthening.” EX1060, 2. FDA also approved
`
`“Powertone” for “abdominal training” and “toning and firming—bottoms/thighs,”
`
`EX1061, 2; and Torc Body, which “contracts muscles rhythmically to achieve
`
`muscle tone and strength.” EX1062, 3. Published patent applications by Pooja
`
`Johari, designer of Powertone and Torc Body, similarly describe the devices and
`
`their use. EX1070, ¶ [0029].
`
`Since at least the 1990s, it also has been known to use magnetic stimulation
`
`for aesthetic purposes to tone muscles. EX1039, ¶ [0085] (“means of muscular
`
`augmentation outside of the medical field by athletes and those desiring increased
`
`muscle mass”); EX1073, ¶ [0027] (for “firming and toning of skin and muscles”);
`
`EX1068, 4:16-5:5 (for weight loss by stimulating abdominal muscles); EX1057, 330
`
`(increasing athletes’ muscle mass and strength); EX1084, 91 (“additional means of
`
`increasing the strength capabilities of athletes”). See EX1023, ¶¶ 58-60.
`
`
`
`
`
`-7-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`FDA approval substantially equates magnetic and electrical stimulation
`
`devices for toning. BTL, seeking 510(k) approval, substantially equated its magnetic
`
`stimulation device (EMSculpt, purportedly an embodiment of the ’634 patent,
`
`(EX1063, ¶ 177)) with Torc Body, an electrical stimulation device. EX1059, 1.
`
`BTL confirmed: “the mechanism of action of the electrical stimulator and this kind
`
`of magnetic device is the same,” and magnetic stimulation for muscle toning, was
`
`nothing new. EX1059, 5-6.
`
`V. Grounds 1-6: The Challenged Claims Are Obvious
`A. REFERENCES
`Burnett ’585: Augmenting Abdominal Muscle Size With
`1.
`Magnetic Stimulation Device Coupled To Body
`U.S. Patent Publication No. 2003/0158585 (“Burnett ’585”) discloses “[a]n
`
`electromagnetic stimulating system and components configured to provide
`
`stimulation to … muscles.” EX1039, Abstract. The system uses a “body-contoured
`
`… appliance” that couples to the body via a strap or buckle “to deliver pulses of
`
`electromagnetic stimulation to targeted regions of the body,” including the abdomen.
`
`Id. The system is used for “muscular augmentation outside of the medical field by
`
`athletes and those desiring increased muscle mass.” EX1039, ¶ [0085].
`
`
`
`
`
`-8-
`
`
`
`

`

`IPR2021-00312
`Patent 10,478,634 B2
`Burnett ’821: Integrating Cooling Into Magnetic
`Stimulation Device Coils
`U.S. Patent Publication No. 2012/0302821 (“Burnett ’821”) discloses a
`
`2.
`
`similar electromagnetic stimulating system and introduces a cooling element for
`
`reducing the temperature of the coils and applicators, and as a result, the skin’s
`
`temperature. EX1040.
`
`3.
`
`Johari: Ramped Pulse Sequences At Different Repetition
`Rates
`U.S. Patent Publication No. 2011/0172735 (“Johari”) discloses “[a]n
`
`electrotherapy stimulation device” for “muscle strengthening,” and calls out
`
`“abdominal muscles” and “buttocks.” EX1041, Abstract, ¶¶ [0004], [0006].
`
`Johari discloses applyi