U.S. Patent No. 10,695,575
`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 IPR2021-01283
`Patent No. 10,695,575
`
`___________
`
`
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`
`
`
`
`

`

`U.S. Patent No. 10,695,575
`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 
`PAYMENT OF FEES .................................................................................... 4 
`III. 
`IV.  REQUIREMENTS FOR INTER PARTES REVIEW ..................................... 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 ............................................................................................ 7 
`A. 
`The ’575 Patent .................................................................................... 7 
`B. 
`Prosecution History .............................................................................. 9 
`VI.  LEVEL OF ORDINARY SKILL IN THE ART .......................................... 10 
`VII.  CLAIM CONSTRUCTION ......................................................................... 10 
`VIII.  GROUNDS OF UNPATENTABILITY ....................................................... 11 
`A.  Ground 1: Claims 16-29 are rendered obvious by Simon .................. 11 
`1. 
`Simon Overview ...................................................................... 11 
`2. 
`Claim Charts ............................................................................ 15 
`a. 
`Independent Claims 16, 24 ...................................................... 15 
`b. 
`Dependent Claims 17-23, 25-29 .............................................. 29 
`Ground 2: Claims 16-29 are rendered obvious by Burnett ’870
`in view of Magstim............................................................................. 39 
`1. 
`Burnett-’870 Overview ............................................................ 39 
`2.  Magstim Overview ................................................................... 42 
`3.  Motivation to Combine ............................................................ 45 
`
`B. 
`
`i
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`

`

`
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`4. 
`Claim Charts ............................................................................ 47 
`Independent Claims 16, 24 ...................................................... 47 
`a. 
`Dependent Claims 17-23, 25-29 .............................................. 60 
`b. 
`A.  Ground 3: Claims 16-29 are rendered obvious by Simon in
`view of Burnett ’870 .......................................................................... 69 
`IX.  SECONDARY CONSIDERATIONS .......................................................... 73 
`X. 
`CONCLUSION ............................................................................................. 74 
`
`
`
`
`
`ii
`
`

`

`
`
`Exhibit
`(Ex-)
`1001
`1002
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`LIST OF EXHIBITS
`
`Description
`
`U.S. Patent No. 10,695,575 (“’575”)
`Declaration of Dr. Marom Bikson (“Bikson”)
`Prosecution history of U.S. Application No. 16/218,735, which led to
`the issuance of the ’575 (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”)
`
`Gorgey et al., Effects of Electrical Stimulation Parameters on
`Fatigue in Skeletal Muscle, J. Orthop. & Sports Phys. Therapy Vol.
`39: 9 (2009) (“Gorgey”)
`
`1015
`
`Stevens et al., Neuromuscular Electrical Stimulation for Quadriceps
`Muscle Strengthening After Bilateral Total Knee Arthroplasty: A
`
`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-)
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`Description
`
`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,
`Federal State Budgetary Educational Institution of Higher
`Professional Education “Velikiye Luki State Academy of Physical
`Culture and Sport”) (English translation) (“Belyaev”)
`
`1029
`
`Andrey Gennadievich Belyaev, Effect of Magnetic Stimulation on the
`Strength Capacity of Skeletal Muscle (2015) (Ph.D. dissertation,
`
`iv
`
`

`

`
`
`Exhibit
`(Ex-)
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`Description
`
`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”)
`
`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”)
`
`v
`
`

`

`
`
`Exhibit
`(Ex-)
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`1056
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`Description
`
`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”)
`
`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”)
`
`vi
`
`

`

`
`
`Exhibit
`(Ex-)
`1057
`
`1058
`
`1059
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`Description
`
`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. 10,695,575
`Petition for Inter Partes Review
`
`I.
`
`INTRODUCTION
`Lumenis Ltd. (“Petitioner”) respectfully requests IPR of Claims 16-29
`
`(“Claims”) of U.S. 10,695,575 (“’575”) pursuant to §§311-319 and §42.100.
`
`’575 is directed to electrical stimulation of body tissues using magnetic field.
`
`’575, 1:53-61. Its exemplary device includes two applicators placed on a patient’s
`
`body causing tissues to contract, thereby “toning’ them. ’575, 5:34-36, 5:50-57,
`
`20:18-19, 29:14–19. Figure 12 (annotated) shows each applicator has a circuit that
`
`contains a capacitor to discharge energy to a magnetic field generating coil. ’575,
`
`20:48-21:23. Bikson, ¶¶92-99.
`
`’575 explains that “magnetic methods” were already in use. ’575, 2:32-35.
`
`Its purported novelty is to combine technologies of “magnetic field with
`
`
`
`
`
`

`

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`radiofrequency, light, mechanical or pressure source.” ’575, 1:53-61, 2:64-67.
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`However, all Claims are directed to merely using magnetic fields for toning
`
`muscles. Bikson, ¶¶92-99, 37-38.
`
`Although the 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, ¶¶104-113, 236.
`
`Burnett-’870 discloses a device with multiple applicators comprising coils to
`
`generate magnetic field to stimulate muscle. Burnett-’870, Abstract, Fig. 9B,
`
`[0114]. Bikson, ¶¶214-226. Magstim discloses fundamentals of magnetic field,
`
`including the parameters and components recited in the Claims. Magstim, 1, 3-4.
`
`Bikson, ¶¶227-235, 413.
`
`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 (IPR2021-01276)
`
`challenging claims 1-15 of the ’575 patent. Due to word count constraints and the
`
`2
`
`

`

`
`large number of claims, requiring 11,946 words in IPR2021-01276 and 13,211
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`words in IPR2021-01283, claims 16-29 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 ’575 patent is not the subject of any other co-pending litigation.
`
`However, the ’575 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) (settled);
` Allergan, Inc. et al v. BTL Medical Technologies SRO et al, PGR2021-
`00020 (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-
`00021 (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. 10,695,575
`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. PAYMENT OF FEES
`The undersigned authorizes the Office to charge the fee required by
`
`§42.15(a) for this Petition for review to Deposit Account No. 18-1945, under Order
`
`No. 116610-0002-655. Any additional fees that might be due are also authorized.
`
`IV. REQUIREMENTS FOR INTER PARTES REVIEW
`A. Grounds for Standing
`Pursuant to §42.104(a), Petitioner certifies ’575 is available for IPR.
`
`4
`
`

`

`
`Petitioner is not barred or estopped from requesting IPR challenging the Claims on
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`the grounds herein.
`
`B.
`Identification of Challenge
`Pursuant to §§42.104(b), Petitioner requests the Board cancel the Claims as
`
`unpatentable.2
`
`1.
`
`Name
`
`Simon
`
`The Specific Art on Which the Challenge is Based
`Exhibit
`Filed
`Published
`Prior art
`
`6/18/2015
`
`§102(a)(1)-(2)
`
`1004
`
`3/3/2015
`
`Burnett-’870 1005
`
`11/20/2013
`
`5/29/2014
`
`§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 ’575 was previously litigated in the ITC, Petitioner had no
`
`
`2 The art predates ’575’s earliest alleged priority date; Petitioner takes no position
`as to the priority claims.
`3 Although Magstim (not previously cited or 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 ’575, while the
`manuals describe product operations.
`
`5
`
`

`

`
`involvement or input to those proceedings, nor any relationship to any party
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`challenging the patent therein. Invalidity of ’575 was not decided in the ITC before
`
`the matter was settled. This petition presents unique grounds not in Allergan’s
`
`PGR2021-00021—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
`16-29
`Simon
`
`2
`
`3
`
`§103
`
`§103
`
`16-29
`
`16-29
`
`Burnett-’870 in view of Magstim
`
`Simon in view of Burnett-’870
`
`See §VIII.
`
`
`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 as primary for disclosing two
`applicators; in contrast, Magstim is used here as a secondary reference for
`disclosing basic magnetic field parameters and applications.
`
`6
`
`

`

`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`
`V. BACKGROUND
`A. The ’575 Patent
`ʼ575 is directed to producing a time-varying magnetic field to remodel or
`
`improve muscles. ’575, 3:13–16, 3:33–34, 3:41–51. It discloses a device with
`
`applicators that may be positioned on target body regions using an “adjustable
`
`belt.” ʼ575, 11:56–58, 20:18–19, Figs. 15-16. Bikson, ¶¶92-93
`
`
`
`
`
`The device includes a “control unit” to regulate magnetic field parameters
`
`and uses a “casing” with a “cooling media” for the applicators. ʼ575, 3:29–32,
`
`10:23-27, 13:10–12, 15:3-7. The device’s circuits have energy storage devices
`
`(i.e., capacitors) that discharge energy to coils as depicted in Figure 12 (annotated).
`
`ʼ575, 21:14–17. Bikson, ¶¶94-95.
`
`7
`
`

`

`
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`The coils generate “impulses” (i.e., “magnetic stimulus”) to cause muscle
`
`contractions. ʼ575, 5:50–52; 13:7–10; 14:31–33. Figure 8 shows that these
`
`impulses are biphasic and sinusoidal:
`
`
`
`8
`
`

`

`
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`
`
`ʼ575, Fig. 8, 5:50–52, 105:48–51. A “pulse” is defined by the period of treatment
`
`between the beginning of a first impulse and the beginning of a second impulse.
`
`ʼ575, 5:53–57. Bikson, ¶¶96-99.
`
`B.
`Prosecution History
`’575 patent issued from U.S. Application No. 16/218,735, filed on
`
`12/13/2018. Ex-1003, 1–116. Track 1, prioritized status was granted. Ex-1003,
`
`131-132. The Examiner issued two §102 rejections for previously-canceled claims
`
`1-2 over Burnett-’585 (US2003/0158585) and Lin (US6,213,933), and two §103
`
`rejections for the same claims based on combinations of Burnett-’585, Lin, and
`
`Vetanze (US2009/0234423). Ex-1003, 133–143. On 07/29/2019, the Examiner
`
`then issued §112 rejections for the 30 new claims, (Ex-1003, 159–166); the
`
`9
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`

`

`
`Applicant canceled those claims and submitted new claims (id. at 176–193), after
`
`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
`
`which the Examiner issued a Notice of Allowance on 12/23/2019 (id. at 251–252).
`
`Bikson, ¶¶100-101.
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART
`On or before 5/10/2016, a POSITA would have had a bachelor’s degree in
`
`biomedical engineering, electrical engineering, physics, or related field, and two or
`
`more years of professional experience working with the design, development,
`
`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 the plain and
`
`ordinary meanings of terms. Bikson, ¶¶102-103. 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).
`
`10
`
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`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
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`VIII. GROUNDS OF UNPATENTABILITY
`A. Ground 1: Claims 16-29 are rendered obvious by Simon
`1.
`Simon Overview
`Simon discloses a magnetic stimulator for muscle “[r]ehabilitation.” Simon,
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`title, [0002], [0197].
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`Simon, Fig. 5, [0103]. Figures 3A-3D (annotated) show Simon’s stimulator with
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`two applicators situated within a “housing,” each applicator containing a “coil”
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`that generates a time-varying magnetic field when a capacitor is “discharged.”
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`Simon, [0012], [0045], [0047], [0098]. Bikson, ¶¶105-106.
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`U.S. Patent No. 10,695,575
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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]-
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`[0028], [0035], [0053]. Simon’s stimulator may contain more than two
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`applicators, with varying shapes and configurations for different applications
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`based on the “anatomical location of the stimulation and determining the
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`appropriate pulse configuration.” Simon, [0031], [0100]-[0102], Fig. 4C-4D.
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`Bikson, ¶¶105-107.
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`Simon’s device has an “impulse generator,” containing a capacitor and
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`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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`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
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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
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`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 parameters for
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`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
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`the stimulation signal including frequency, pulse amplitude, and repetition rate.
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`Simon, [0059], [0063]-[0064], [0104]. Bikson, ¶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].
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`Simon recognizes magnetic stimulator coils “overheat” during “extended” use, so
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`it discloses solutions such as “cool[ing] the coils” with flowing water, air, or
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`“ferrofluids.” Simon, [0020]. Bikson, ¶¶111-112.
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`To the extent argued Simon lacks explicit disclosure of independently-
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`positioned applicators in its preferred embodiment, a POSITA would have found it
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`obvious to modify Simon to use independently-positioned applicators, e.g.,
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`detached applicators because Simon teaches applicators with varying shapes and
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`configurations for different applications, e.g., based on the “anatomical location of
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`the stimulation and determining the appropriate pulse configuration.” Simon,
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`[0031], [0100]-[0102] (“general” “geometrical configuration”; device design is
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`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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`U.S. Patent No. 10,695,575
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`provide the expected functionality. Bikson, ¶¶113, 69-71.
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`Moreover, to the extent argued Simon lacks disclosure of first/second
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`connecting tubes for flowing oil to first/second applicators, a POSITA would have
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`found it obvious to modify Simon to use connecting tubes in order to cool
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`first/second applicators to avoid coils “overheat[ing]” when used over an extended
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`period of time, such as for muscle “rehabilitation.” Simon, [0020], [0197]. Simon
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`leaves the exact cooling details to a POSITA, who would have been motivated to
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`use connecting tubes for oil to flow from a source to the applicator and provide
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`cooling. Such a routine change in device cooling would predictably work and
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`provide the expected functionality. Bikson, ¶¶114, 78-82.
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`2.
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`Claim Charts
`a.
`Independent Claims 16, 24
`Claim Language
`Simon
`[16.pre]6 A
`Simon discloses a method for toning muscles of a patient.
`method for toning
`Simon discloses “[m]agnetic stimulation devices and
`muscles of a
`methods of therapy” for muscle “rehabilitation,” which a
`patient,
`POSITA would have recognized as muscle toning. Simon,
`comprising:
`title, Abstract, [0197]; AM-100, 3, 5 (device for “muscle
`toning”); HPM-6000, 3 (same device used for
`“muscle...rehabilitative purposes”); Bikson ¶¶115-116, 39-
`67.
`Simon teaches independently positioning a first and a
`[16.a]
`second applicator laterally on at least one body region of
`independently
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`6 To the extent the preambles are limiting, they are met by the art of record.
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`U.S. Patent No. 10,695,575
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`Simon
`the patient, wherein the body region is the patient's
`abdomen, such that the first and second applicators are
`located on left and right sides of the body, respectively.
`Simon discloses a “stimulator” that may have two
`applicators “that lie side-by-side,” each containing a “coil”
`disposed in “its own housing”:
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`
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`Claim Language
`positioning a first
`and a second
`applicator laterally
`on at least one
`body region of the
`patient, wherein
`the body region is
`the patient's
`buttocks or
`abdomen, such that
`the first and second
`applicators are
`located on left and
`right sides of the
`body, respectively;
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`
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`Simon, Fig. 3A-D (annotated), [0031], [0098]. Simon
`further discloses the stimulator “positioned…on or near a
`patient's…abdomen…” and cites prior art
`“abdomen” treatment. Simon, [0035], [0105], [0175].
`Simon is not limited to two applicators; the shapes and
`configurations may vary based on, e.g., “anatomical location
`of the stimulation.” Simon, [0031], [0100]-[0102], Fig. 4C-
`4D.
`Simon discloses it was known in the prior art to have
`independently-positioned applicators, such as a “negative
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`Claim Language
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`[16.b] attaching
`both the first and
`the second
`applicator to the
`body region by a
`belt;
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`[16.c] charging a
`first energy storage
`device and a
`second energy
`storage device;
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`U.S. Patent No. 10,695,575
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`Simon
`electrode” placed on “ulnar edge of the forearm” and a
`“positive electrode” placed on “abdomen.” Simon, [0175].
`A POSITA would have understood and found it obvious that
`Simon’s applicators may be independently positioned—see
`§VIII.A.2. It was known in the art to position applicators
`independently, including laterally on left and right sides of
`the body. See, e.g., Belanger, Fig. 13-16, 241-42, 246;
`Burnett-’870, [0087], [0114], [0209], Fig. 9B (“abdominal
`garment” on left/right buttocks). Bikson, ¶¶117-122, 69-71.
`Simon discloses attaching both the first and the second
`applicator to the body region by a belt (e.g., “strap,
`harnesses”).
`Simon discloses fixing a stimulator having two applicators to
`a body region (e.g., “abdomen”; see [8.a] above) with
`“[s]traps, harnesses, or frames,” i.e., a belt, to “maintain the
`stimulator in position.” Simon, [0147], [0154], [0168],
`[0182]. For example, Simon discloses “using a strap” to
`hold stimulator coils “against the patient.” Simon, [0194].
`Bikson, ¶¶123-124, 72-75.
`Simon discloses charging a first energy storage device
`(e.g., “capacitor”) and a second energy storage device (e.g.,
`“capacitor”).
`Simon discloses a device with “an impulse generator”
`coupled to a “power source” and “control unit”:
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`Simon, Fig. 1, [0054].
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`Claim Language
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`[16.d] discharging
`the first energy
`storage device to a
`first circular
`magnetic field
`generating coil to
`generate a first
`pulse of a first
`time-varying
`magnetic field,
`wherein the first
`pulse comprises a
`first impulse and a
`time of no
`stimulation;
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`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
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`Simon
`The “impulse generator” contains “a capacitor,” which stores
`energy when “[charged]…under the control of a control
`unit.” Simon, [0019].
`Simon discloses using “a bank of capacitors,” i.e., charging
`multiple energy storage devices for “[g]reater flexibility”
`such that they are discharged “at different times” or
`“sequentially” to generate multiple, and serial pulses as
`demanded for varying treatment options. Simon, [0019],
`[0063].
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`Bikson, ¶¶125-129, 76-77.
`Simon discloses discharging the first energy storage
`device (e.g., “capacitor”) to a first circular magnetic field
`generating coil (e.g., “first coil”) to generate a first pulse
`(e.g., “pulse”/“impulse” plus “inter-stimulus interval”) of a
`first time-varying magnetic field (e.g., “first… time-
`varying magnetic field[]”), wherein the first pulse
`comprises a first impulse (e.g., “pulse”/“impulse”) and a
`time of no stimulation (e.g., “inter-stimulus interval”).
`See [16.a], [16.c]—Simon discloses charging multiple
`capacitors including in a “bank of capacitors”—each is
`“discharged through the coil.” Simon, [0019]. 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]. Simon
`discloses a “pulse” (referred to as “impulse” in the language
`of the patent) duration, disclosing each impulse has an “inter-
`stimulus interval,” i.e., space between consecutive impulses
`forming the claimed pulse. Simon, cls. 9-10; [0030], [0033],
`[0059], [0104]; see also Herbst, [0037] (“two…pulses” with
`“adjustable delay between them”). Bikson, ¶¶43.
`Simon’s “apparatus” induces a “time-varying magnetic
`field” to apply “energy” to a target region within a “patient.”
`Simon, Abstract, [0015], [0023]-[0024], [0053]. The
`apparatus is placed, e.g., “on or near a patient’s neck, ankle,
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`Claim Language
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`U.S. Patent No. 10,695,575
`Petition for Inter Partes Review
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`Simon
`and abdomen” in order to produce an “intended beneficial
`physiological effect.” Simon, [0035]-[0036].
`Simon discloses circular coils. Simon, Figs. 3, 4a-4b; [0017]
`(“circular” coil known in prior art).
`Simon further discloses current “passed through the coils in
`bursts of pulses” repeating at 1-5000Hz with “1-20 pulses
`per burst”—accordingly, a first impulse is followed by a
`time of no stimulation. Simon, [0030], Fig. 2 (depicting
`impulses with no stimulation in between):
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`[16.e] discharging
`the second energy
`storage device to a
`second circular
`magnetic field
`generating coil to
`generate a first
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`Simon Fig. 2. Bikson, ¶¶130-134, 43.
`Simon discloses discharging the second energy storage
`device (e.g., “capacitor”) to a second circular magnetic
`field generating coil to generate a first impulse of a
`second time-varying magnetic field (e.g., “second time-
`varying magnetic field[]”) after the first pulse of the first
`time-varying magnetic field (e.g., “first… time-varying
`magnetic field[]”) begins but before the first pulse of the
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`Claim Language
`impulse of a
`second tim