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 PGR2021-00024
`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
`
`I.
`II.
`
`B.
`
`C.
`
`PAGE
`INTRODUCTION .......................................................................................... 1
`THE ’576 PATENT ........................................................................................ 2
`A.
`The Alleged Invention .......................................................................... 2
`B.
`The Prosecution History ....................................................................... 4
`III. THIS PETITION MEETS PGR REQUIREMENTS (37 C.F.R.
`§ 42.204) ......................................................................................................... 4
`A. Grounds For Standing (37 C.F.R. § 42.204(a)) ................................... 4
`B.
`Identification Of The Challenged Claims And Statutory
`Grounds (37 C.F.R. § 42.204(b)(1), (2), (4), & (5)) ............................ 4
`Claim Construction (37 C.F.R. § 42.204(b)(3)) ................................... 6
`C.
`Person Of Ordinary Skill In The Art .................................................... 7
`D.
`IV. MUSCLE STIMULATION DEVICES WERE WELL-KNOWN IN
`THE ART ........................................................................................................ 8
`A.
`The Principles Of Bioelectricity For Inducing Muscle
`Contraction Were Well Understood by 2016 ....................................... 8
`Using Magnetic And Electrical Stimulation For Muscle
`Contraction Was Well-Known ............................................................. 9
`Using Stimulation Devices For Toning Muscle Was Also Well-
`Known By 2016 .................................................................................. 12
`V. GROUND 1: THE “CONTROL UNIT” CLAIMS 1-22 AND 24 ARE
`UNPATENTABLE UNDER § 112(f) .......................................................... 14
`A.
`“Control Unit” Is A Means-Plus-Function Term ............................... 14
`B.
`The Specification Fails To Disclose Adequate Structure For
`The “Control Unit” ............................................................................. 17
`VI. GROUNDS 2-5: THE CLAIMS ARE UNPATENTABLE UNDER §
`103 ................................................................................................................ 23
`A. Overview Of The References ............................................................. 23
`1.
`Remed Salus Talent Pop – Two-Applicator Magnetic
`Stimulation Device ................................................................... 23
`Porcari – Electrical Stimulation ............................................... 25
`
`2.
`
`
`
`
`
`-i-
`
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`

`

`B.
`
`TABLE OF CONTENTS
`(Continued)
`
`6.
`
`5.
`
`PAGE
`3. Mo – Ramp Modulation (Trapezoidal Envelope) .................... 25
`4.
`Errico – Mobile Device Nerve Stimulation (Touchscreen) ..... 26
`Ground 2: Claims 1-15, 23, 25-26, And 28-29 Are Obvious
`Over Pop In View Of Porcari ............................................................. 26
`1.
`Independent Claim 1 ................................................................ 29
`2.
`Independent Claim 8 ................................................................ 47
`3.
`Independent Claim 23 .............................................................. 53
`4.
`Claim 2 (holding applicators proximate to left/right
`muscles) (108:6-17) ................................................................. 60
`Claim 3 (simultaneously generate magnetic fields)
`(109:18-22) ............................................................................... 60
`Claim 4 (plurality of pulses, time period of no impulse)
`(109:23-27) ............................................................................... 61
`Claim 5 (inner and outer radii) (109:28-32) ............................ 62
`7.
`Claim 6 (constant pulse repetition rates) (109:33-36) ............. 63
`8.
`Claim 7 (pulse durations) (109:37-45) ..................................... 65
`9.
`10. Claim 9 (synchronously generated magnetic fields)
`(110:35-38) ............................................................................... 66
`11. Claim 10 (equal inductances) (110:39-44) .............................. 66
`12. Claim 11 (plurality of pulses, repetition rate, muscle
`contraction, different areas of body region) (110:45-58) ........ 66
`13. Claim 12 (cooling media, magnetic fields, single
`treatment) (110:59-63) ............................................................. 67
`14. Claim 13 (varying repetition rates) (110:64-66; 111:1-18) ..... 67
`15. Claim 14 (bursts, repetition rates, time with no magnetic
`pulse) (111:19-34) .................................................................... 70
`16. Claim 15 (radiofrequency electrode) (111:35-36) ................... 72
`17. Claim 25 (independently generate magnetic fields)
`(114:17-19) ............................................................................... 73
`
`
`
`
`
`-ii-
`
`
`
`

`

`TABLE OF CONTENTS
`(Continued)
`
`C.
`
`3.
`
`4.
`
`PAGE
`18. Claim 26 (optical waves) (114:20-23) ..................................... 73
`19. Claim 28 (pulse repetition rates) (114:36-45) ......................... 74
`20. Claim 29 (constant repetition rates) (114:46-48) ..................... 77
`Ground 3: Claims 16-19 Are Obvious Over Pop and Mo................. 77
`1.
`Independent Claim 16 .............................................................. 78
`2.
`Claim 17 (holding applicators proximate to left/right
`muscles) (112:33-46) ............................................................... 86
`Claim 18 (independently positioned, inductances)
`(112:47-55) ............................................................................... 86
`Claim 19 (connecting tubes, source of cooling liquid)
`(112:56-61) ............................................................................... 86
`D. Ground 4: Claims 20-22, 27, And 30 Are Obvious Over Pop In
`View Of Porcari And Mo ................................................................... 86
`1.
`Claim 20 (belt, single treatment) (112:62-65) ......................... 86
`2.
`Claim 21 (positioning applicators) (112:66-67; 113:1-4) ........ 87
`3.
`Claim 22 (laterally positioning, dorsal/ventral sides)
`(113:5-10) ................................................................................. 87
`Claim 27 (plurality of bursts, time periods, repetition
`rate, increasing/decreasing amplitude) (114:24-35) ................ 88
`Claim 30 (pulse sequences, varying amplitudes) (114:49-
`65) ............................................................................................ 88
`Ground 5: Claim 24 Is Obvious Over Pop, Porcari, And Errico ...... 88
`1.
`Claim 24 (billing system) (114:12-16) .................................... 88
`Secondary Considerations Of Non-Obviousness ............................... 89
`F.
`VII. GROUNDS 6-7: THE CLAIMS ARE INVALID UNDER § 112(a) .......... 89
`A. Ground 6: All Claims (1-30) Are Invalid For Insufficient
`Written Description ............................................................................ 90
`Ground 7: All Claims (1-30) Are Not Enabled .................................. 96
`B.
`VIII. INSTITUTION IS WARRANTED .............................................................. 97
`
`4.
`
`5.
`
`E.
`
`
`
`
`
`-iii-
`
`
`
`

`

`TABLE OF CONTENTS
`(Continued)
`
`PAGE
`IX. CLAIM LISTING ....................................................................................... 103
`X. Mandatory Notices...................................................................................... 115
`A.
`Real Party In Interest (37 C.F.R. § 42.8(b)(1)) ................................ 115
`B.
`Related Matters (37 C.F.R. § 42.8(b)(2)) ......................................... 115
`C.
`Identification Of Service Information (37 C.F.R. § 42.8(b)(3)
`and (b)(4)) ......................................................................................... 116
`
`
`
`
`
`-iv-
`
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`
`

`

`PGR2021-00024
`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
`
`Abbreviated File History of the ʼ321 patent
`
`1013
`
`Reserved
`
`
`
`
`
`-i-
`
`
`
`

`

`PGR2021-00024
`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
`Stimulation (“Magstim”)
`
`1016
`
`Reserved
`
`1017
`
`U.S. Patent Application Publication No. 2006/0187607 (“Mo”)
`
`1018
`
`Reserved
`
`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
`
`Reserved
`
`1022
`
`Reserved
`
`1023
`
`Declaration of Dr. Pedro Irazoqui
`
`1024
`
`Declaration of Maria P. Garcia
`
`
`
`
`
`-ii-
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`

`

`PGR2021-00024
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`EXHIBIT
`NO.
`1025
`
`Reserved
`
`1026
`
`Reserved
`
`1027
`
`Reserved
`
`1028
`
`Reserved
`
`1029
`
`Reserved
`
`1030
`
`Reserved
`
`1031
`
`Reserved
`
`1032
`
`Reserved
`
`1033
`
`Reserved
`
`1034
`
`Reserved
`
`1035
`
`Reserved
`
`1036
`
`Reserved
`
`1037
`
`Reserved
`
`
`
`
`
`-iii-
`
`
`
`

`

`PGR2021-00024
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`EXHIBIT
`NO.
`1038
`
`Reserved
`
`1039
`
`U.S. Patent Application Publication No. 2003/0158585
`(“Burnett ’585”)
`
`1040
`
`Reserved
`
`1041
`
`U.S. Patent Application Publication No. 2011/0172735 (“Johari”)
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`Declaration of Kyu Tai Joo, Chief of Research and Development at
`Remed Co. Ltd.
`
`Korean Food & Drug Administration (“KFDA”) Approval for Salus
`Talent Pop (2011), certified English translation of Appendix A to
`Declaration of Kyu Tai Joo (EX1042)
`
`KFDA Approval Certificate for Salus Talent Pop, certified English
`translation of Appendix B to Declaration of Kyu Tai Joo (EX1042)
`
`Invoice for 2012 Sale of Salus Talent Pop, certified English
`translation of Appendix C to Declaration of Kyu Tai Joo (EX1042)
`
`Salus Talent Pop User’s Manual (2012), certified English translation
`of Appendix F to Declaration of Kyu Tai Joo (EX1042)
`
`Salus Talent Pop Brochure (2012), certified English translation of
`Appendix G to Declaration of Kyu Tai Joo (EX1042)
`
`
`
`
`
`-iv-
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`

`

`PGR2021-00024
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`TESLA Stym – FMS – Functional Magnetic Stimulation Website
`(2013)
`
`EXHIBIT
`NO.
`1048
`
`1049
`
`Iskra Medical, TESLA Stym Brochure (2013)
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`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)
`
`Geddes, History of Magnetic Stimulation of the Nervous System,
`8(1) Journal of Clinical Neurophysiology (1991)
`
`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)
`
`
`
`
`
`-v-
`
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`
`

`

`PGR2021-00024
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`EXHIBIT
`NO.
`1056 Man et al., Magnetic stimulation for the measurement of respiratory
`and skeletal muscle function, European Respiratory Journal, 24:846-
`860 (2004)
`
`TITLE
`
`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
`
`1064
`
`U.S. Patent No. 5,766,124 (“Polson”)
`
`1065
`
`U.S. Patent Application Publication No. 2014/0046423 (“Rajguru”)
`
`1066
`
`Reserved
`
`
`
`
`
`-vi-
`
`
`
`

`

`PGR2021-00024
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`EXHIBIT
`NO.
`1067
`
`TITLE
`
`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”)
`
`1075
`
`U.S. Patent Application Publication No. 2010/0331603 (“Szecsi”)
`
`1076
`
`Reserved
`
`
`
`
`
`-vii-
`
`
`
`

`

`PGR2021-00024
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`Schaefer et al., Review of Patient Safety in Time-Varying Gradient
`Fields, Journal of Magnetic Resonance Imaging, 12:20-29 (2000)
`
`EXHIBIT
`NO.
`1077
`
`1078
`
`The Oxford Handbook of Transcranial Stimulation, Chapter 3
`(2008)
`
`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
`
`1086 Mogyoros et al., Strength-duration properties of human peripheral
`nerve, Brain 119(2):439-447 (1996)
`
`
`
`
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`-viii-
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`

`PGR2021-00024
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`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
`
`International Application Publication No. WO 2015/179571
`(“Errico”)
`
`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)
`
`EXHIBIT
`NO.
`1087
`
`1088
`
`1089
`
`1090
`
`1091
`
`1092
`
`1093
`
`Declaration of Vladislav Ugryumov (authenticating EX1083,
`EX1088)
`
`1094
`
`Reserved
`
`
`
`
`
`-ix-
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`PGR2021-00024
`Patent 10,695,576 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
`
`Reserved
`
`1098
`
`1099
`
`1100
`
`Barker, The history and basic principles of magnetic nerve
`stimulation (1999)
`
`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-
`
`
`
`

`

`PGR2021-00024
`Patent 10,695,576 B2
`TABLE OF EXHIBITS
`(Continued)
`
`TITLE
`
`EXHIBIT
`NO.
`1105
`
`Reserved
`
`1106
`
`U.S. Patent No. 10,610,696 (“Peled”)
`
`
`
`
`
`
`
`-xi-
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`

`PGR2021-00024
`Patent 10,695,576 B2
`TABLE OF ABBREVIATIONS
`Abbreviation
`
`Term
`U.S. Patent No. 10,695,576
`Analog-to-Digital Converters
`Application Specific Integrated
`Circuits
`BTL Industries, Inc.
`Digital Signal Processors
`Electrical Muscle Stimulation
`International Application Publication
`WO 2015/179571
`Field Programmable Gate Arrays
`Hertz
`Lowest Replaceable Unit
`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.
`Programmable Logic Devices
`Person Of Ordinary Skill In The Art
`Tesla
`
`’576 patent
`ADC
`ASIC
`
`BTL
`DSP
`EMS
`Errico
`
`FPGA
`Hz
`LRU
`Mo
`
`Patent Owner
`Patentee
`Petitioners
`
`PLD
`POSITA
`T
`
`
`
`
`
`
`
`-i-
`
`
`
`

`

`PGR2021-00024
`Patent 10,695,576 B2
`
`I.
`
`INTRODUCTION
`The ’576 patent is precisely the type of patent for which post-grant review is
`
`intended. While the challenged patents recite lengthy device claims that
`
`superficially mix and match device parameters, ranges, components, and parts with
`
`known time-varying magnetic field use parameters in broad ranges, they all suffer
`
`from the same flaw: None recites anything inventive at all. They merely recycle
`
`conventional devices for magnetic stimulation causing muscle contraction that were
`
`well-known in the art. The ranges for the well-known parameters within the claims
`
`are so broad that numerous prior-art devices fall squarely within, and render obvious,
`
`the claims.
`
`During prosecution of the application for the parent to the ’576 patent, the
`
`Examiner labored under the impression that “the prior art sets forth a very limited
`
`number of teachings that set forth magnetic treatments that cause muscle
`
`contraction.” EX1011, 43. But, long before Patent Owner filed for the ’576 patent,
`
`one of the Petitioners, Remed Co. Ltd., sold a magnetic stimulation device that
`
`treated patients by inducing repeated muscle contractions and relaxations, and: (1)
`
`included virtually all of the claimed components; and (2) generated magnetic fields
`
`that fell squarely within the claimed parameters values. While the claims may recite
`
`elements that may formally avoid anticipation, they were obvious and taught in view
`
`of ample references, including those presented here.
`
`
`
`
`
`-1-
`
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`

`

`PGR2021-00024
`Patent 10,695,576 B2
`To the extent Patent Owner argues that the art failed to disclose any
`
`purportedly novel aspect of the claims, the specification does not back that up. The
`
`patent discloses nothing beyond what was already known in the art. It does not even
`
`include a single working example of any claim, much less sufficient disclosure either
`
`demonstrating the Applicant’s possession of the purported inventions or enabling
`
`anyone to practice the claims in any manner purportedly claimed as inventive.
`
`Under each of the Grounds presented in this Petition, the claims should be
`
`held unpatentable. Patent Owner’s attempt to monopolize an obvious combination
`
`of known elements not even sufficiently taught in the specification fails under
`
`Sections 103 and 112. The Board should grant review.
`
`II. THE ’576 PATENT
`A. The Alleged Invention
`The ’576 patent purports to claim magnetic treatments and devices for
`
`aesthetics, or “toning a muscle.” EX1003, 108:13. It claims priority to numerous
`
`applications, the earliest of which was filed May 10, 2016.1 EX1003, 1:47-53. The
`
`patent issued on June 30, 2020, and recites 30 claims. Four claims are independent:
`
`claims 1, 8, 16, and 23.
`
`
`1 Petitioners do not concede the patent is entitled to this priority date.
`
`
`
`
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`PGR2021-00024
`Patent 10,695,576 B2
`Each of the independent claims recites well-known interdependent parameters
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`for 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 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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`PGR2021-00024
`Patent 10,695,576 B2
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`The Prosecution History
`B.
`At the Applicant’s request, the ’576 patent application was examined under
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`the Track One program. EX1010, 3, 20-21. During this expedited review, the
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`Applicant overwhelmed the Examiner with hundreds of prior art documents.
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`EX1010, 32-63.
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`The 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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`Examiner allowed the claims presented in the preliminary amendment without a
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`single rejection. EX1010, 22-31; see EX1023, ¶ 99-101.
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`III. THIS PETITION MEETS PGR REQUIREMENTS (37 C.F.R. § 42.204)
`A. Grounds For Standing (37 C.F.R. § 42.204(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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`Identification Of The Challenged Claims And Statutory Grounds
`(37 C.F.R. § 42.204(b)(1), (2), (4), & (5))
`Petitioners challenge all claims (1-30) of the ’576 patent on these grounds2:
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`2 The remainder of this Petition explains how the claims are unpatentable on
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`these Grounds, and further provides a detailed claim listing (Section IX).
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`Ground
`1
`2
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`3
`4
`5
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`6
`7
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`Claims
`1-22, 24
`1-15, 23, 25-
`26, 28-29
`16-19
`20-22, 27, 30
`24
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`1-30
`1-30
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`PGR2021-00024
`Patent 10,695,576 B2
`Basis for Rejection
`§ 112(f) Indefiniteness: the term “control unit”
`§ 103(a) based on Pop in view of Porcari
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`§ 103(a) based on Pop in view of Mo
`§ 103(a) based on Pop in view of Mo
`§ 103(a) based on Pop in view of Porcari, and
`Errico
`§ 112(a): Lack of Written Description
`§ 112(a): Non-Enablement
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`As demonstrated in the Overview of the Prior Art below:
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`• Pop and Porcari each qualify as prior art under § 102(a)(1); and,
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`• Mo and Errico each qualify as prior art under § 102(a)(1) and
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`(a)(2).
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`Mo, Errico and general documentation regarding Remed’s Salus Talent and
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`Salus Talent Pro products were included in the hundreds of references cited to the
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`Examiner. Patent Owner attempted to submit a one-page document that referenced
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`the Pop, which had different features than the other Remed products, but failed to
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`provide the requisite publication information and the Examiner did not consider it.
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`EX1010, 61. Further, the Examiner never applied Mo, Errico, or any documentation
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`Additional explanation and support for each ground is set forth in the Declaration
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`of Dr. Pedro Irazoqui (EX1023), which is referenced throughout this Petition.
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`PGR2021-00024
`Patent 10,695,576 B2
`for the other Remed products against the claims or even discussed those references
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`during prosecution of the ’576 patent. The Board has consistently held that such
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`circumstances do not favor § 325(d) discretion. Bowtech, Inc. v. MCP IP, LLC,
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`IPR2019-00379, Paper 14 at 18-19 (PTAB July 3, 2019) (distinguishing art the
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`Examiner actually considered from art merely cited to the Examiner).
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`C. Claim Construction (37 C.F.R. § 42.204(b)(3))
`The Board gives claims their ordinary and customary meaning, or “the
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`meaning that the term would have to a [POSITA] at the time of the invention.”
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`Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc).
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`The term “control unit” is an indefinite means-plus-function term, as
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`explained in Section V below. To the extent the term is not held indefinite, the
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`grounds in Sections VI and VII demonstrate that the claims reciting a “control unit”
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`also would have been unpatentable under Sections 103 or 112(a).
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`Another term warranting construction is “toning” (“toned”), which should be
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`given its plain and ordinary meaning as confirmed in the patent: an enhanced visual
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`appearance of a body region or muscle caused by induced muscle contractions that
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`strengthen, firm, volumize, or tighten the muscle. See, e.g., EX1003, Abstract, 2:33-
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`36, 3:57-62, 23:28-37. As the specification explains, “muscle toning” is an effect
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`where “[t]he muscle may gain strength without adipose tissue reduction,” and this
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`PGR2021-00024
`Patent 10,695,576 B2
`“effect may be known as muscle strengthening, muscle toning or muscle firming.”
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`EX1003, 25:36-39.
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`For purposes of this proceeding, Petitioners submit that the remaining claim
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`terms should be interpreted consistent with their ordinary and customary meaning,
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`unless the applicant provided an express definition in the specification. See, e.g.,
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`EX1003, 4:63-6:24. Petitioners submit that such terms should be interpreted
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`consistent with the definition set forth in the specification. 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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`Person Of Ordinary Skill In The Art
`D.
`A person of ordinary skill in the art (“POSITA”) at the time of the alleged
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`invention would include a person (or a group of people) familiar with the design,
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`development, and use of devices that apply electrical energy directly, or indirectly
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`via magnetic fields, to the body to stimulate biological tissue (e.g., brains, spinal
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`cords, nerves, or muscles). The skilled artisan’s group would include: (i) a person
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`with at least a bachelor’s degree in electrical engineering, biomedical engineering,
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`physics, or related field of study, and at least two years’ experience in academia or
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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, and the claim construction process is ongoing.
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`PGR2021-00024
`Patent 10,695,576 B2
`industry researching, designing, or developing such devices, and (ii) a medical
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`doctor, healthcare provider, researcher, or other person having a degree in medicine,
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`physiology, neuroscience, kinesiology, physical therapy, biomechanics, or a related
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`discipline and two or more years of using, researching, designing, or developing
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`such devices. See EX1023, ¶¶ 1-26, 65-68.
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`The prior art cited by the Applicant and the Examiner during prosecution
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`reflects this level of skill. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
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`2001); see, e.g., Section VI below.
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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 by 2016
`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., EX1052, 26-27; 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
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`PGR2021-00024
`Patent 10,695,576 B2
`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 1023, ¶¶ 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; EX1052,
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`26-27. Two well-known and similar modalities were used to induce current in
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`biological tissues: magnetic stimulation and electrical stimulation. Whereas
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`electrical stimulation applies current directly to the body, magnetic stimulation—in
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`particular, the use of “time-varying” magnetic fields—induces a current indirectly
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`by being applied on or near a body region. See EX1069, ¶ [0003]; EX1052, 27-28;
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`EX1051, 39; EX1054, 3, 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. E.g., EX1051, 39 (“The cellular mechanism of
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`stimulation is the same for both [electrical and magnetic] techniques.”); EX1052, 27
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`Patent 10,695,576 B2
`(“The mechanism of stimulation at the neural level is thought to be the same for both
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`magnetic and electrical stimulation . . . .”).
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`Moreover, devices for both modalities were well-known. And, these devices
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`used the same or similar parameters for stimulation. See, e.g., EX1072, 702;
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`EX1050, 59; EX1057, 330. These include: the intensity of the energy stimulus
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`(which, for magnetic stimulation includes the magnetic flux density, in Tesla, the
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`magnetic flux density derivative, in kT/s); the duration of a pulse, measured in units
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`of time; the pulse repetition rate, in hertz; the number of pulses in a group (“train”);
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`and the time from one train to the next (which the ’576 patent describes as a “burst”),
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`in units of time. EX1015, 11-12, 43; EX1003, 34:4-11. The artisan did use
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`knowledge about the two modalities and the parameters interchangeably. The
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`artisan further understood that these parameters are interrelated, for example, shorter
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`impulses require a higher magnetic field or current strength than longer pulses to
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`induce muscle contractions, and that large muscles require more energy to stimulate
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`than small muscles. EX1055, 16. It was also understood that sustained muscle
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`contractio