U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`LUMENIS LTD.,
`Petitioner,
`
`v.
`
`
`BTL HEALTHCARE TECHNOLOGIES A.S.,
`Patent Owner.
`
`___________
`
`
`Case IPR2021-01282
`Patent No. 10,632,321
`
`___________
`
`
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`
`
`
`
`

`

`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`TABLE OF CONTENTS
`
`V. 
`
`INTRODUCTION .......................................................................................... 1 
`I. 
`II.  MANDATORY NOTICES UNDER 37 C.F.R. §42.8 ................................... 2 
`A. 
`Real Party-in-Interest ........................................................................... 2 
`B. 
`Related Matters ..................................................................................... 2 
`C. 
`Lead and Back-Up Counsel .................................................................. 4 
`FEES PAYMENT ........................................................................................... 4 
`III. 
`IV.  REQUIREMENTS FOR IPR ......................................................................... 4 
`A.  Grounds for Standing ........................................................................... 4 
`B. 
`Identification of Challenge ................................................................... 5 
`1. 
`The Specific Art on Which the Challenge is Based .................. 5 
`a. 
`§§314(a) and 325(d) are inapplicable ........................................ 5 
`2. 
`Statutory Grounds on Which the Challenge is based ................ 6 
`BACKGROUND ............................................................................................ 6 
`A. 
`’321 Patent ............................................................................................ 6 
`B. 
`Prosecution History .............................................................................. 8 
`VI.  LEVEL OF ORDINARY SKILL IN THE ART ............................................ 8 
`VII.  CLAIM CONSTRUCTION ........................................................................... 9 
`VIII.  GROUNDS OF UNPATENTABILITY ......................................................... 9 
`A.  Ground 1: Claims 15-30 are rendered obvious by Simon .................... 9 
`1. 
`Simon Overview ........................................................................ 9 
`2. 
`Claim Charts ............................................................................ 15 
`a. 
`Independent Claims 15, 23 ...................................................... 15 
`b. 
`Dependent Claims 16-22, 24-30 .............................................. 33 
`Ground 2: Claims 15-30 are rendered obvious by Burnett ʽ870
`in view of Magstim............................................................................. 41 
`1. 
`Burnett-’870 Overview ............................................................ 41 
`2.  Magstim Overview ................................................................... 44 
`3.  Motivation to Combine ............................................................ 47 
`
`B. 
`
`i
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`

`

`
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`4. 
`Claim Charts ............................................................................ 49 
`Independent Claims 15, 23 ...................................................... 49 
`a. 
`Dependent Claims 16-22, 24-30 .............................................. 66 
`b. 
`A.  Ground 3: Claims 15-30 are rendered obvious by Simon in
`view of Burnett ’870 .......................................................................... 74 
`IX.  SECONDARY CONSIDERATIONS .......................................................... 79 
`X. 
`CONCLUSION ............................................................................................. 79 
`
`
`
`
`
`ii
`
`

`

`
`
`Exhibit
`(Ex-)
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`LIST OF EXHIBITS
`
`Description
`U.S. Patent No. 10,632,321 (“’321”)
`
`Declaration of Dr. Marom Bikson (“Bikson”)
`
`Prosecution history of U.S. Application No. 16/673,683, which led to
`the issuance of the ’321 (excerpts) (the “’683 Application”)
`
`U.S. Patent Application Publication No. 2015/0165226 (“Simon”)
`
`U.S. Patent Application Publication No. 2014/0148870 (“Burnett-
`’870”)
`
`Chris Hovey et al., The Guide To Magnetic Stimulation, Magstim,
`July 21, 2006, Affidavit (“Magstim”)1
`
`U.S. Patent Application Publication No. US20050216062 (“Herbst”)
`
`U.S. Pat. No. 7,396,326 (“Ghiron”)
`
`U.S. Pat. No. 10,675,819 (“Li”)
`
`U.S. Pat. Pub. No. 2014/0277219A1 (“Nanda”)
`
`Alain-Yvan Belanger, Therapeutic Electrophysical Agents, 3d
`Edition, Wolters Kluwer (2015), Declaration (“Belanger”)
`
`U.S. Pat. Pub. No. 2012/0245483 (“Lundqvist”)
`
`U.S. Patent Application Publication No. 2010/0168501 from
`Application No. 12/508,529 (“Burnett-’529”)
`
`
`1 All pinpoint citations to Magstim, throughout this document and the
`corresponding expert declaration, refer to the page number originally in Magstim
`itself (i.e., in the bottom middle portion of Magstim).
`
`iii
`
`

`

`
`
`Exhibit
`(Ex-)
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`Description
`Gorgey et al., Effects of Electrical Stimulation Parameters on
`Fatigue in Skeletal Muscle, J. Orthop. & Sports Phys. Therapy Vol.
`39: 9 (2009) (“Gorgey”)
`
`Stevens et al., Neuromuscular Electrical Stimulation for Quadriceps
`Muscle Strengthening After Bilateral Total Knee Arthroplasty: A
`Case Series, Journal of Orthopaedic & Sports Physical Therapy,
`34(1):21-29 (2004) (“Stevens”)
`
`Doucet et al., Neuromuscular Electrical Stimulation for Skeletal
`Muscle Function, Yale Journal of Biology & Medicine 85:201-215
`(2012) (“Doucet”)
`
`Abulhasan et al., Peripheral Electrical and Magnetic Stimulation to
`Augment Resistance Training, Journal of Functional Morphology and
`Kinesiology, 1(3):328-342 (2016) (“Abulhasan”)
`
`Remed, Salus Talent Brochure (2010) (“Salus”)
`
`Iskra Medical, TESLA Stym Website (2013) (“TESLA Stym”)
`
`510(k) Summary, No. K163165, AM-100 (2017) (“AM-100”)
`
`510(k) Summary, No. K160992, HPM-6000 (2016) (“HPM-6000”)
`
`U.S. Pat. Pub. No. 2003/0158585 (“Burnett ʼ585”)
`
`U.S. Provisional Patent Application Ser. No. 60/848,720 (“Burnett-
`Provisional-’720”)
`
`U.S. Pat. No. 6,701,185 (“Burnett-’185”)
`
`U.S. Pat. Pub. No. 2008/0306325 (“Burnett-ʼ325”)
`
`U.S. Pat. No. 6,155,966 ( “Parker”)
`
`U.S. Pat. No. 5,344,384 (“Ostrow”)
`
`Andrey Gennadievich Belyaev, Effect of Magnetic Stimulation on the
`Strength Capacity of Skeletal Muscle (2015) (Ph.D. dissertation,
`
`iv
`
`

`

`
`
`Exhibit
`(Ex-)
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`Description
`Federal State Budgetary Educational Institution of Higher
`Professional Education “Velikiye Luki State Academy of Physical
`Culture and Sport”) (English translation) (“Belyaev”)
`
`Andrey Gennadievich Belyaev, Effect of Magnetic Stimulation on the
`Strength Capacity of Skeletal Muscle (2015) (Ph.D. dissertation,
`Federal State Budgetary Educational Institution of Higher
`Professional Education “Velikiye Luki State Academy of Physical
`Culture and Sport”) (Russian)
`
`U.S. Pat. No. 7,024,239 (“George”)
`
`U.S. Pat. No. 5,181,902 (“Erickson”)
`
`U.S. Pat. Pub. No. 2006/0199992 (“Eisenberg”)
`
`U.S. Pat. No. 5,718,662 (“Jalinous”)
`
`U.S. Pat. No. 5,061,234 (“Chaney”)
`
`U.S. Pat. No. 10,271,900 (“Marchitto”)
`
`U.S. Pat. Pub. No. 2016/0184601 (“Gleich”)
`
`Judith Woehrle et al., Dry Needling and its Use in Health Care – A
`Treatment Modality and Adjunct for Pain Management, J. Pain &
`Relief, 4(5):1-3 (2015) (“Woehrle”)
`
`U.S. Patent Publication No. 2015/0157873 (“Sokolowski”)
`
`U.S. Patent No. 7,744,523 (“Epstein”)
`
`U.S. Pat. No. 6,738,667 (“Deno”)
`
`U.S. Pat. No. 6,871,099 (“Whitehurst”)
`
`U.S. Patent Application Publication No. US20050075701 (“Shafer-
`’701”)
`
`v
`
`

`

`
`
`Exhibit
`(Ex-)
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`Description
`U.S. Patent Application Publication No. US20050075702 (“Shafer-
`’702”)
`
`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) (“Suarez-Bagnasco”)
`
`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-
`Electric”)
`
`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) (“Zhi-De-Deng-
`Electromagnetic”)
`
`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”)
`
`U.S. Patent No. 9,089,719 (“Simon-ʼ719”)
`
`U.S. Patent No. 9,037,247 (“Simon-ʼ247”)
`
`U.S. Patent No. 8,868,177 (“Simon-ʼ177”)
`
`File History of U.S. Patent Application No. 12/859,568 (excerpts)
`(“File-history-ʼ568”)
`
`vi
`
`

`

`
`
`Exhibit
`(Ex-)
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`Description
`File History of U.S. Patent Application No. 12/964,050 (excerpts)
`(“File-history-ʼ050”)
`
`File History of U.S. Patent Application No. 13/005,005 (excerpts)
`(“File-history-ʼ005”)
`
`File History of U.S. Patent Application No. 13/024,727 (excerpts)
`(“File-history-ʼ727”)
`
`Allergan, Inc. et al v. BTL Medical Technologies SRO et al,
`PGR2021-00017, Paper 16 (Institution Denial Decision on §112(f))
`(“PGR2021-00017-ID”)
`
`Allergan, Inc. et al v. BTL Medical Technologies SRO et al,
`PGR2021-00020 (PTAB, Filed Dec. 14, 2020), Paper 16 (Institution
`Denial Decision on §112(f)) (“PGR2021-00020-ID”)
`
`1060
`
`Declaration of Jonathan Bradford
`
`vii
`
`

`

`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`I.
`
`INTRODUCTION
`Lumenis Ltd. (“Petitioner”) respectfully requests IPR of Claims 15-30
`
`(“Claims”) of U.S. 10,632,321 (“’321”) pursuant to §§311-319 and §42.100.
`
`’321 is directed to electrical stimulation of body tissues using magnetic field.
`
`’321, 1:21-30. Its exemplary device includes two applicators placed on a patient’s
`
`body causing tissues to contract, thereby “toning’ them. ’321, 6:21-23, 6:37-40,
`
`20:4-5, 28:63–29:1. Figure 12 (annotated) shows each applicator has a circuit that
`
`contains a capacitor to discharge energy to a magnetic field generating coil. ’321,
`
`20:25-67. Bikson, ¶¶92-99.
`
`’321 explains that “magnetic methods” were already in use. ’321, 2:1-4. Its
`
`purported novelty is to combine technologies of “magnetic field with
`
`
`
`
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`

`

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`radiofrequency, light, mechanical or pressure source.” ’321, 1:27-30, 2:33-36.
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`However, Claims are directed to merely using magnetic fields for toning muscles.
`
`Bikson, ¶¶92-99, 37-38.
`
`Although Claims are lengthy, reciting parameters and components, these
`
`elements are conventional features well known in the art. Bikson, ¶¶68-91. Simon
`
`discloses a magnetic device with two applicators for stimulating muscles during
`
`rehabilitation. Simon, Abstract, [0053]-[0054], [0197]. Bikson, ¶¶104-114, 271.
`
`Burnett-’870 discloses a device with multiple applicators comprising coils to
`
`generate magnetic field to stimulate muscle. Burnett-’870, Abstract, Fig. 9B,
`
`[0114]. Bikson, ¶¶272-283. Magstim discloses fundamentals of magnetic field,
`
`including parameters and components recited in the Claims. Magstim, 1, 3-4.
`
`Bikson, ¶¶284-290, 499.
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. §42.8
`A. Real Party-in-Interest
`Lumenis Ltd. is the real party-in-interest. No other party had access to or
`
`control over the present Petition, and no other party funded or participated in
`
`preparation of the present Petition.
`
`B. Related Matters
`Petitioner is concurrently filing another petition (IPR2021-01275)
`
`challenging claims 1-14 (i.e., the “method for toning” claims) of the ’321 patent.
`
`2
`
`

`

`
`Due to word count constraints and the large number of claims, requiring 13,996
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`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`words in IPR2021-01275 and 13,985 words in IPR2021-01282, claims 15-30 (i.e.,
`
`the “treatment device” claims) are presented separately herein. See PTAB
`
`Consolidated Trial Practice Guide, November 2019, 59-61 (permitting parallel
`
`petitions in certain circumstances, such as a large number of claims).
`
`The ’321 patent is not the subject of any other co-pending litigation.
`
`However, the ’321 patent was the subject of the following litigations that were
`
`stayed or resolved and did not involve or relate to the Petitioner:
`
` Certain Non-Invasive Aesthetic Body Contouring Devices, Components
`
`Thereof, and Methods of Using the Same, Inv. No. 337-TA-1219 (ITC,
`
`Filed Aug. 5, 2020) (the “ITC Case”) (settled);
`
` BTL Industries, Inc. v. Allergan Ltd. et al, No. 1-20-cv-01046 (D. Del., Filed
`
`Aug. 5, 2020) (stayed) (settled);
`
` Allergan, Inc. et al v. BTL Medical Technologies SRO et al, PGR2021-
`
`00017 (PTAB, Filed Dec. 14, 2020) (“Allergan’s PGR”) (Institution denied
`
`on §112 grounds and §103 grounds primarily based on on-sale bar and
`
`public use of a device);
`
` Allergan, Inc. et al v. BTL Medical Technologies SRO et al, PGR2021-
`
`00018 (PTAB, Filed Dec. 14, 2020) (“Allergan’s PGR”) (Institution denied
`
`on a different set of §103 grounds than those presented in this Petition).
`
`3
`
`

`

`
`
`C. Lead and Back-Up Counsel
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`Lead Counsel
`Scott A. McKeown
`Reg. No. 42,866
`ROPES & GRAY LLP
`2099 Pennsylvania Avenue, NW
`Washington, D.C. 20006-6807
`Phone: +1-202-508-4740
`Fax: +1-617-235-9492
`scott.mckeown@ropesgray.com
`
`
`Mailing address for all PTAB
`correspondence:
`ROPES & GRAY LLP
`IPRM—Floor 43
`Prudential Tower
`800 Boylston Street
`Boston, Massachusetts 02199-3600
`
`Backup Counsel
`James L. Davis, Jr.
`Reg. No. 57,325 (Back-up)
`Keyna Chow
`Pro Hac Vice (Back-up)
`ROPES & GRAY LLP
`1900 University Avenue, 6th Floor
`East Palo Alto, CA 94303-2284
`Phone: 650-617-4000
`Fax: 617-235-9492
`James.l.davis@ropesgray.com
`Keyna.Chow@ropesgray.com
`
`
`
`Petitioner consents to electronic service of documents to the email addresses
`
`of the counsel identified above.
`
`III. FEES PAYMENT
`Undersigned authorizes the Office to charge the fee required by §42.15(a) to
`
`Deposit Account No. 18-1945, under Order No. 116610-0002-654. Any additional
`
`fees are also authorized.
`
`IV. REQUIREMENTS FOR IPR
`A. Grounds for Standing
`Pursuant to §42.104(a), Petitioner certifies ’321 is available for IPR.
`
`4
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`

`

`
`Petitioner is not barred or estopped from requesting IPR challenging the Claims on
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`the grounds herein.
`
`B.
`Identification of Challenge
`Pursuant to §§42.104(b), Petitioner requests cancelling the Claims as
`
`unpatentable.2
`
`1.
`
`Name
`
`The Specific Art on Which the Challenge is Based
`Exhibit
`Filed
`Published
`Prior art
`
`6/18/2015
`5/29/2014
`
`1004
`Simon
`Burnett-’870 1005
`
`3/3/2015
`11/20/2013
`
`§102(a)(1)-(2)
`§102(a)(1)-(2)
`
`Magstim
`
`1006
`
`--
`
`7/21/2006
`
`§102(a)(1)
`
`a.
`§§314(a) and 325(d) are inapplicable
`Simon and Magstim3 were not before Examiner; Burnett-’870 was cited in
`
`an IDS among hundreds of references, but not otherwise identified or applied to
`
`reject claims during prosecution. Examiner never considered the testimony of Dr.
`
`Bikson (Ex-1002) regarding these documents. Ex-1003.
`
`Although ’321 was previously litigated in ITC, Petitioner had no
`
`
`2 The art predates ’321’s earliest priority date; Petitioner takes no position as to the
`priority claims.
`3 Although Magstim (not previously cited/considered) and the operating manuals
`(cited but not applied to reject claims) are from the same company, the respective
`disclosures are substantially different—Magstim is a guide that teaches stimulation
`principles, techniques, and applications claimed in ’321, while the manuals
`describe product operations.
`
`5
`
`

`

`
`involvement or input to those proceedings, nor relationship to any party therein;
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`’321 Invalidity was not decided before the matter was settled. This petition
`
`presents unique grounds not presented in PGR2021-00018—neither Simon nor
`
`Burnett-’8704 was asserted; and Magstim5 is not applied the same way as in any
`
`prior ground, which prevent application of §§314(a) and 325(d) denial.
`
`2.
`Statutory Grounds on Which the Challenge is based
`Ground Statute Claim(s)
`Prior Art
`1
`§103
`15-30
`Simon
`
`2
`
`3
`
`§103
`
`§103
`
`15-30
`
`15-30
`
`Burnett-’870 in view of Magstim
`
`Simon in view of Burnett-’870
`
`See §VIII.
`
`V. BACKGROUND
`A.
`’321 Patent
`’321 is directed to producing a time-varying magnetic field to remodel or
`
`improve muscles. ’321, 2:49-52, 2:63-65, 3:4-14. It discloses a device with
`
`
`4 The Board denied a set of grounds based on modifying US2003/0158585
`(“Burnett ’585”), which discloses an insulated coil and does not discuss the need
`for cooling, to include liquid/oil cooling from a secondary reference. In contrast,
`here, Burnett-’870, a patent publication that came ten years after, discloses
`cooling a coil that is not insulated.
`5 Magstim served as a primary reference in the PGR for disclosing two
`applicators; in contrast, Magstim is asserted here as a secondary reference for
`disclosing basic magnetic field parameters and applications.
`
`6
`
`

`

`
`applicators positioned on target body regions using an “adjustable belt.” ’321,
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`11:58-60, 20:4-5, Figs. 15-16.
`
`
`
`
`
`The device includes a “control unit” to regulate magnetic field parameters and uses
`
`a “casing” with a “cooling media” for the applicators. ’321, 2:58-62, 10:26-30,
`
`13:13-15, 15:6-10. Its circuits have energy storage devices (i.e., capacitors) that
`
`discharge energy to coils. ’321, 20:58-61. Bikson, ¶¶92-94.
`
`The coils generate “impulses” (i.e., “magnetic stimulus”) to cause muscle
`
`contractions. ’321, 6:37-40; 14:34-36. Figure 8 shows that impulses are biphasic
`
`and sinusoidal:
`
`7
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`

`

`
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`
`
`’321, Fig. 8, 6:37-40, 105:53-56. A “pulse” is defined by the period of treatment
`
`between the beginning of a first impulse and the beginning of a second impulse.
`
`’321, 6:41-44. Bikson, ¶¶95-99.
`
`B.
`Prosecution History
`’321 issued from application No. 16/673,683, filed on 11/4/2019. Ex-1003,
`
`1–173. Track 1, prioritized status was granted, and no art-based rejections were
`
`issued, and on 2/19/2020, Examiner allowed the claims as filed. Ex-1003, 279-
`
`280. Bikson, ¶¶100-101.
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART
`On or before July 1, 2016, a POSITA would have had a bachelor’s degree in
`
`biomedical engineering, electrical engineering, physics, or related field, and two or
`
`8
`
`

`

`
`more years of professional experience working with the design, development,
`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`and/or use of devices that apply electromagnetic energy to stimulate biological
`
`tissue. Additional graduate education could substitute for professional experience,
`
`or significant experience in the field could substitute for formal education. Bikson,
`
`¶¶1-36.
`
`VII. CLAIM CONSTRUCTION
`Claim terms subject to IPR are to be construed according to the Phillips
`
`standard applied in district court. §42.100(b). Petitioner applies plain and ordinary
`
`meanings of terms. Only terms necessary to resolve the controversy must be
`
`construed. Nidec Motor v. Zhongshan Broad Ocean Motor, 868 F.3d 1013, 1017
`
`(Fed. Cir. 2017). Bikson, ¶¶102-103. Pursuant to §42.104(b)(3), regarding the term
`
`“control unit,” the Board has denied institution on Allergan’s PGR determining
`
`that the term is not indefinite and does not invoke §112(f). PGR2021-00017-ID,
`
`10-16.
`
`VIII. GROUNDS OF UNPATENTABILITY
`A. Ground 1: Claims 15-30 are rendered obvious by Simon
`1.
`Simon Overview
`Simon discloses a magnetic stimulator for muscle “[r]ehabilitation.” Simon,
`
`title, [0002], [0197]. Bikson, ¶105.
`
`9
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`

`

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`
`U.S. Patent No. 10,632,321
`Petition for Inter Partes Review
`
`
`
`Simon, Fig. 5, [0103]. Figures 3A-3D (annotated) show Simon’s stimulator with
`
`two applicators situated within a “housing,” each applicator containing a “coil”
`
`that generates a time-varying magnetic field when a capacitor is “discharged.”
`
`Simon, [0012], [0045], [0047], [0098]. Bikson, ¶¶105-106.
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`Each coil “induces an electromagnetic field” to apply “electrical impulses” to
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`muscles within target body regions (e.g., abdomen). Simon, [0024], [0027]-
`
`[0028], [0035], [0053]. Simon’s stimulator may contain more than two
`
`applicators, with varying shapes and configurations for different applications
`
`based on “anatomical location of the stimulation and determining the appropriate
`
`pulse configuration.” Simon, [0031], [0100]-[0102], Fig. 4C-4D. Bikson, ¶¶105-
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`107.
`
`Simon’s device has an “impulse generator,” containing a capacitor and
`
`connected to a “control unit” causing the impulse generator to generate a signal for
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`each coil. Simon, [0019], [0057], Fig. 1. The control unit controls the capacitor
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`via switching. Simon, [0019]. The impulse generator may contain a “bank of
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`capacitors” discharged to coils at different times such that multiple, and serial
`
`pulses may be generated. Simon, [0019], [0063]. Bikson, ¶¶108-109.
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`Simon’s coils generate consecutive “energy impulses” to stimulate tissue:
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`Simon, Fig. 2, [0002], [0029], [0035]. Simon teaches adjustable stimulation
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`parameters including frequency, pulse amplitude, and repetition rate. Simon,
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`[0059], [0063]-[0064], [0104]. Bikson, ¶¶105-110.
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`Simon aims to “significantly less[en] pain or discomfort” during treatment.
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`Simon, [0016], [0123]. Applied current may be “increased gradually, first to a
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`level wherein the patient feels sensation,” then “set to a level.” Simon, [0123].
`
`Simon recognizes coils “overheat” during “extended” use, so it discloses solutions
`
`to “cool the coils” with flowing water or “ferrofluids.” Simon, [0020]. Bikson,
`
`¶¶111-112.
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`To the extent argued Simon lacks explicit disclosure of independently-
`
`positioned applicators in its preferred embodiment, a POSITA would have found it
`
`obvious to modify Simon to use independently-positioned applicators, e.g.,
`
`detached applicators because Simon teaches applicators with varying shapes and
`
`configurations for different applications, e.g., based on the “anatomical location of
`
`the stimulation and determining the appropriate pulse configuration.” Simon,
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`[0031], [0100]-[0102] (“general” “geometrical configuration”; device design is
`
`shaped by “anatomical location of the stimulation”); Fig. 4C-4D. Simon leaves the
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`exact configuration of the applicators to a POSITA, who would have been
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`motivated to have detached, independently-positioned applicators for muscle
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`“rehabilitation” on muscle groups such as the “abdomen.” Simon, [0035], [0197].
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`Such a routine change in configuration of applicators would predictably work and
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`provide the expected functionality. Bikson, ¶¶113, 69-71.
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`To the extent argued that Simon does not explicitly disclose a trapezoidal
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`envelope, a POSITA would have been motivated and found it obvious to ramp
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`down the current after it has been ramped-up then “set to a level,” forming a
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`trapezoidal envelope (Simon, [0123]) to mimic muscle contraction and relaxation
`
`as was known in the art. See, e.g., Belanger, 239 (disclosing to apply trapezoidal
`
`envelope to mimic the “gradual build up and relaxation phases” during “voluntary
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`muscle contraction” for “smooth” contraction to increase patient comfort); Herbst
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`[0030]; [0047] (“[s]awtooth” with “rise and fall ramp”; “[a]rbitrary waveform”).
`
`Simon teaches applying stimulation in a manner avoiding “discomfort,” and once
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`current is increased, it must either be ramped down gradually or abruptly cut off,
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`such that a POSITA would have had a finite number of options to gradually relax
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`the muscle. Simon, [0016]. Such a routine change in signal amplitude, which
`
`Simon discloses is “adjustable,” would predictably work and provide the expected
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`functionality based on the explained teachings. Simon, [0063]. Bikson, ¶¶114, 88-
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`90.
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`2.
`
`Claim Elements
`[15.pre] A
`treatment device
`for toning
`muscles of a
`patient using
`time-varying
`magnetic fields,
`the treatment
`device
`comprising:
`
`[15.a] a control
`unit;
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`U.S. Patent No. 10,632,321
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`Claim Charts
`a.
`Independent Claims 15, 23
`Simon
`Simon discloses a treatment device (e.g., “Magnetic
`stimulation device”) for toning muscles of a patient using
`time-varying magnetic fields.
`Simon discloses “[m]agnetic stimulation devices and methods
`of therapy” for purposes including muscle “rehabilitation,”
`which POSITAs would have recognized is a form of muscle
`toning. Simon, title, Abstract, [0197]; AM-100, 3, 5 (device
`for “muscle toning”); HPM-6000, 3 (same device used for
`“muscle...rehabilitative purposes”); Bikson ¶¶37-67.
`Simon discloses an “apparatus” that induces a “time-varying
`magnetic field” to apply “energy” to a target region within a
`patient”; and it may be placed on “abdomen” to produce
`“intended beneficial physiological effect.” Simon, Abstract,
`[0015], [0023]-[0024], [0035]-[0036], [0053], [0105], [0175].
`Bikson ¶¶115-116, 37-67.
`
`
`Simon discloses a control unit (e.g., “control unit”).
`Simon discloses a device with “an impulse generator” coupled
`to a “power source” and “control unit”:
`
`
`The “control unit” controls the “impulse generator” which
`stores energy by charging a capacitor to “generate a signal for
`each of the device’s magnetic stimulation coils.” Simon,
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`15
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`
`
`Claim Elements
`
`[15.b] a first
`energy storage
`device;
`
`[15.c] a second
`energy storage
`device;
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`Simon
`[0019], [0057]. Control is based on “feedback” from
`“externally supplied physiological or environmental signals.”
`Simon, [0058].
`A user may “operate the system” by typing “instructions” for
`the control unit and may view results on a “monitor.” Simon,
`[0058]. Bikson ¶¶117-119.
`Simon discloses a first energy storage device (e.g.,
`“capacitor”).
`Simon discloses that a “capacitor, after being
`“[charged]…under the control of a control unit” is
`“discharged” through each coil when a user wishes to “apply
`[a] stimulus.” Simon, [0019], [0025], Fig. 3A-D. Bikson
`¶¶120-121, 76-77.
`Simon discloses a second energy storage device (e.g.,
`“capacitor”).
`See [15.b]—Simon discloses using “bank of capacitors,” for
`“[g]reater flexibility” such that they are discharged “at
`different times”/“sequentially” to generate multiple, and serial
`pulses as demanded for varying treatment options. Simon,
`[0019], [0063]. Simon discloses “first and second time-
`varying magnetic fields” are generated by “first and second
`coils.” Simon, [0025]. Simon teaches an implementation
`according to Herbst’s teaching (incorporated) to use “a
`plurality of []signal generators, each producing a signal” for a
`corresponding output. Simon, [0063]; Herbst, [0037], [0070].
`POSITAs would understand that Simon teaches individual
`capacitors may be discharged into corresponding coils such
`that separate pulses may be provided to the two coils.
`POSITAs would have been motivated and found it obvious to
`use a separate capacitor for each coil allowing it to be
`discharged with separate/differential patterns, or at separate
`times to provide versatility in stimulation treatment, and to
`allow separate placement of coils for flexible treatment of
`muscles of different sizes/locations. Bikson ¶¶122-124, 69-77.
`
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`Claim Elements
`[15.d] a first
`applicator, the
`first applicator
`comprising:
`
`Simon
`Simon discloses a first applicator (e.g., first applicator of
`“stimulator 30”).
`Simon discloses a “stimulator 30” containing applicators and
`connected to “a circuit control box 38”:
`
`
`
`Simon, Fig. 5 (annotated); [0103].
`The stimulator 30 may have two applicators “that lie side-by-
`side,” each containing a “coil[] 35” disposed in “its own
`housing 37”:
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`Claim Elements
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`U.S. Patent No. 10,632,321
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`Simon
`
`
`
`Simon, Fig. 3A-D (annotated), [0031], [0098].
`Simon is not limited to two applicators; the shapes and
`configurations may vary based on, e.g., “the anatomical
`location of the stimulation.” Simon, [0031], [0100]-[0102],
`Fig. 4C-4D. Bikson ¶¶125-128, 69-71.
`
`Simon discloses a first casing (e.g., “housing 37”).
`Simon discloses each applicator has “its own housing 37” for
`a “coil[] 35”; and that the “housing” provides “mechanical
`support to the coil and core,” and “electrical[] insulat[ion]”
`from a “neighboring coil.” Simon, [0098], Fig. 3A-D. Bikson
`¶¶129-130.
`Simon discloses a first magnetic field (e.g., “first… magnetic
`field[]”) generating coil (e.g., “first coil”) disposed within
`the first casing (e.g., “housing 37”).
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`[15.e] a first
`casing; and
`
`[15.f] a first
`magnetic field
`generating coil
`disposed within
`the first casing;
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`

`

`
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`Claim Elements
`
`[15.g] a first
`connecting tube
`coupling the first
`applicator to the
`control unit,
`wherein the first
`connecting tube
`includes a first
`fluid conduit
`configured to
`direct cooling
`media to the first
`magnetic field
`generating coil;
`
`[15.h] a second
`applicator, the
`second applicator
`comprising:
`[15.i] a second
`casing; and
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`U.S. Patent No. 10,632,321
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`Simon
`See [15.d]-[15.e]—a “time-varying magnetic field” is induced
`at each “coil” by “passing a time-varying current through [the]
`coil.” Simon, [0015], [0025]. Bikson ¶¶131-132.
`Simon teaches a first connecting tube coupling the first
`applicator (e.g., first applicator of “stimulator 30”) to the
`control unit (e.g., “control unit”), wherein the first
`connecting tube includes a first fluid conduit (e.g.,
`“channel”) configured to direct cooling media (e.g.,
`“[f]errofluid cooling”) to the first magnetic field generating
`coil (e.g., “first coil”).
`See [15.a]—Simon discloses a “control unit” connected to the
`applicators.
`Simon recognizes that “coils…overheat when used over an
`extended period” such that cooling was needed. Simon,
`[0020].
`Simon discloses that known cooling solutions existed—
`“cool[ing] the coils with flowing water”/“ferrofluids,” which
`are generally oil-based. Simon, [0020]; Li, 6:13-14 (“oil-
`based ferrofluid”). Simon references Ghiron as a “solution”
`of “[f]errofluid cooling” to overheating problem. Simon,
`[0020]. Ghiron teaches using “channel 40” to “convey
`ferrofluid 30” to a stimulator’s coil. Ghiron, 5:47-54, 9:1-10.
`POSITAs would have been motivated and found it obvious to
`apply prior art teachings to direct cooling media (e.g.,
`ferrofluid) to the coil of the stimulator as taught in Simon.
`Bikson ¶¶133-136, 78-82.
`Simon discloses a second applicator (e.g., second applicator
`of “stimulator 30”).
`See [15.d]. Bikson ¶¶137-138, 69-71.
`
`Simon discloses a second casing (e.g., “housing 37”).
`See [15.e]. Bikson ¶¶139-140.
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`Claim Elements
`[15.j] a second
`magnetic field
`generating coil
`disposed within
`the second
`casing;
`[