U.S. Patent No. 10,821,295
`Petition for Inter Partes Review
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`LUMENIS BE LTD.,
`Petitioner,
`
`v.
`
`
`BTL HEALTHCARE TECHNOLOGIES A.S.,
`Patent Owner.
`
`___________
`
`
`Case IPR2021-01402
`Patent No. 10,821,295
`
`___________
`
`
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`
`
`
`
`

`

`U.S. Patent No. 10,821,295
`Petition for Inter Partes Review
`TABLE OF CONTENTS
`
`V. 
`
`INTRODUCTION .......................................................................................... 1 
`I. 
`II.  MANDATORY NOTICES UNDER 37 C.F.R. §42.8 ................................... 3 
`A. 
`Real Party-in-Interest ........................................................................... 3 
`B. 
`Related Matters ..................................................................................... 3 
`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. 
`Specific Art on Which the Challenge is Based .......................... 5 
`2. 
`Statutory Grounds on Which the Challenge is based ................ 5 
`BACKGROUND ............................................................................................ 6 
`A. 
`’295 Patent ............................................................................................ 6 
`B. 
`Prosecution History ............................................................................ 10 
`C. 
`§325(d) is inapplicable ....................................................................... 11 
`VI.  LEVEL OF ORDINARY SKILL IN THE ART .......................................... 13 
`VII.  CLAIM CONSTRUCTION ......................................................................... 14 
`VIII.  GROUNDS OF UNPATENTABILITY ....................................................... 14 
`A.  Ground 1: Claims 1-7, 23-30 are rendered obvious by Simon in
`view of Edoute .................................................................................... 14 
`1. 
`Simon Overview ...................................................................... 14 
`2. 
`Edoute Overview ...................................................................... 19 
`3.  Motivation to Combine ............................................................ 21 
`4. 
`Claim Charts ............................................................................ 23 
`a. 
`Independent Claims 1 and 23 ................................................... 23 
`b. 
`Dependent Claims 2-7, 24-30 .................................................. 34 
`Ground 2: Claims 1-7, 23-30 are rendered obvious by Simon in
`view of Edoute and Park .................................................................... 41 
`
`B. 
`
`i
`
`

`

`
`
`U.S. Patent No. 10,821,295
`Petition for Inter Partes Review
`
`C. 
`
`1. 
`Park Overview .......................................................................... 41 
`Discussion ................................................................................ 44 
`2. 
`Ground 3: Claims 1-7, 23-30 are rendered obvious by Burnett-
`’870 in view of Park and Zarsky ........................................................ 45 
`1. 
`Burnett-’870 Overview ............................................................ 45 
`2. 
`Zarsky Overview ...................................................................... 48 
`3.  Motivation to Combine ............................................................ 49 
`4. 
`Claim Charts ............................................................................ 52 
`a. 
`Independent Claims 1 and 23 ................................................... 52 
`b. 
`Dependent Claims 2-7, 24-30 .................................................. 59 
`IX.  SECONDARY CONSIDERATIONS .......................................................... 69 
`X. 
`CONCLUSION ............................................................................................. 69 
`
`
`
`
`
`ii
`
`

`

`
`
`Exhibit
`(Ex-)
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`U.S. Patent No. 10,821,295
`Petition for Inter Partes Review
`
`LIST OF EXHIBITS
`
`Description
`U.S. Patent No. 10,821,295 (“’295”)
`
`Declaration of Dr. Marom Bikson (“Bikson”)
`
`Prosecution history of U.S. Application No. 16/266,570, which led to
`the issuance of the ’295 (excerpts)
`
`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”)
`
`Reserved
`
`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. 10,821,295
`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. 10,821,295
`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-’900”)
`
`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. 10,821,295
`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
`
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`1065
`
`1066
`
`1067
`
`1068
`
`1069
`
`1070
`
`1071
`
`1072
`
`U.S. Patent No. 10,821,295
`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”)
`
`Reserved
`
`Reserved
`
`Reserved
`
`U.S. Patent Application Publication No. 2015/0025299 (“Edoute”)
`
`Reserved
`
`U.S. Patent Application Publication No. 2011/0172735 (“Johari”)
`
`U.S. Patent Application Publication No. 2013/0123765 (“Zarsky”)
`
`Reserved
`
`U.S. Patent Application Publication No. 2020/0155221 (“Marchitto-
`’221”)
`
`Reserved
`
`Reserved
`
`U.S. Patent Application Publication No. 2016/0129274 (“Park”)
`
`U.S. Patent Application Publication No. 2001/0031906 (“Ishikawa”)
`
`U.S. Patent No. 5,766,124 (“Polson”)
`
`Reserved
`
`vii
`
`

`

`
`
`Exhibit
`(Ex-)
`1073
`
`1074
`
`1075
`
`1076
`
`1077
`
`1078
`
`1079
`
`1080
`
`1081
`
`1082
`
`U.S. Patent No. 10,821,295
`Petition for Inter Partes Review
`
`Description
`U.S. Patent Application Publication No. 2009/0284339 (“Choi”)
`
`Javier Ruiz-Esparza & Julio Barba Gomez, The Medical Face Lift: A
`Noninvasive, Nonsurgical Approach to Tissue Tightening in Facial
`Skin Using Nonablative Radiofrequency, Dermatol Surg 29:325-332
`(2003) (“Ruiz-Esparza”)
`
`Nils Krueger et al., Safety and Efficacy of a New Device Combining
`Radiofrequency and Low-Frequency Pulsed Electromagnetic Fields
`for the Treatment of Facial Rhytides, J Drugs Dematol. 11(11):1306-
`1309 (2012) (“Krueger”)
`
`U.S. Patent No. 10,195,454 (“Yamashiro”)
`
`Venus Concept Ltd., Venus Freeze MP2 User Manual International
`(2012) (“Venus Freeze”)
`
`European Patent EP 2069014 B1 (“Hancock”)
`
`U.S. Patent No. 8,204,446 (“Scheer”)
`
`Agilent 33500 Series 30 MHz Function / Arbitrary Waveform
`Generator User’s Guide (“Agilent”)
`
`Jim Turley, Agilent Technologies Announces 30 MHz
`Function/Arbitrary Waveform Generators with Unparalleled Signal
`Accuracy, Elec. Eng’g J. (Aug. 4, 2010),
`https://www.eejournal.com/article/20100804-03/ (“Turley”)
`
`Agilent Announces 30 MHz Function/Arbitrary Waveform
`Generators, Microwave J. (Aug. 3, 2010),
`https://www.microwavejournal.com/articles/9851-agilent-announces-
`30-mhz-function-arbitrary-waveform-generators (“Microwave”)
`
`1083
`
`Declaration of Jonathan Bradford
`
`viii
`
`

`

`U.S. Patent No. 10,821,295
`Petition for Inter Partes Review
`
`I.
`
`INTRODUCTION
`Lumenis Be Ltd. (“Petitioner”) respectfully requests IPR of Claims 1-7, 23-
`
`30 (“Claims”) of U.S. 10,821,295 (“’295”) pursuant to §§311-319 and §42.100.
`
`ʼ295 is directed to treating a patient using a combination of a time-varying
`
`magnetic field and radiofrequency waves, to provide “improved treatment.” ʼ295,
`
`Abstract, 2:1–7, 4:12–15, 6:42–49. Its exemplary device includes two applicators
`
`placed on a patient’s body, which apply radiofrequency waves to heat muscles and
`
`apply magnetic fields to cause the muscles to contract, thereby “ton[ing] the
`
`muscle[, and] providing a more attractive appearance.” ʼ295, 3:53–67, 6:50–52,
`
`28:60–62, see also id., 6:66–7:1; 19:13–14.
`
`Figure 11a shows a treatment device (44) including a magnetic field
`
`generating device (45) and a radiofrequency (RF) means (46). ʼ295, 98:23–26.
`
`Bikson, ¶¶102-105.
`
`
`
`
`
`

`

`ʼ295 explains that both “magnetic methods” a well as “radiofrequency
`
`U.S. Patent No. 10,821,295
`Petition for Inter Partes Review
`
`
`
`treatment” were already in use, but that these “treatment methods…[were] used
`
`separately.” ʼ295, 2:17–27, 2:45–47. Thus, ʼ295’s purported novelty is to
`
`combine technologies of “magnetic field with radiofrequency.” ʼ295, 2:4–7.
`
`Indeed, ʼ295 Claims require both a magnetic field and radiofrequency waves.
`
`ʼ295, cls. 1–30. Bikson, ¶¶41-42.
`
`But the combination of magnetic stimulation and heat treatment using
`
`radiofrequency waves was well-known and the claimed features were merely
`
`conventional. Bikson, ¶¶43-101. Edoute discloses a device for applying RF and
`
`magnetic field simultaneously to target body region for complementary effect
`
`resulting from simultaneous heat (RF) and electromagnetic stimulation on muscles.
`
`Edoute, Abstract, [0200]. Park discloses treating a patient with a combination of
`
`pulsed electromagnetic field and heat energy such as RF for “firming muscles.”
`
`Park, [0004], [0036]. Zarsky discloses circuit components to generate RF for
`
`treating tissues. Zarsky, Abstract, Fig. 1. Bikson, ¶¶122-124, 215-218, 229-230,
`
`323.
`
`2
`
`

`

`U.S. Patent No. 10,821,295
`Petition for Inter Partes Review
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. §42.8
`A. Real Party-in-Interest
`Lumenis Be 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 (IPR2021-01403)
`
`challenging claims 8-22 of the ’295 patent. Due to word-count constraints and the
`
`large number of claims, requiring 12,449 words in IPR2021-01402 and 12,404
`
`words in IPR2021-01403, claims 1-7, 23-30 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 ’295 patent is not the subject of any other litigation.
`
`3
`
`

`

`
`
`C. Lead and Back-Up Counsel
`
`U.S. Patent No. 10,821,295
`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. 116610-0004-651. 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 ’295 is available for IPR.
`
`4
`
`

`

`
`Petitioner is not barred or estopped from requesting IPR challenging the Claims on
`
`U.S. Patent No. 10,821,295
`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.
`
`Specific Art on Which the Challenge is Based
`Exhibit
`Filed
`Published
`Prior art
`1004
`3/3/2015
`6/18/2015
`§102(a)(1)-(2)
`
`1061
`
`1005
`
`1064
`
`1069
`
`9/18/2014
`
`1/22/2015
`
`§102(a)(1)-(2)
`
`11/20/2013
`
`5/29/2014
`
`§102(a)(1)-(2)
`
`11/16/2011
`
`5/16/2013
`
`§102(a)(1)-(2)
`
`11/10/2014
`
`5/12/2016
`
`§102(a)(2)
`
`Name
`Simon
`
`Edoute
`
`Burnett-’870
`
`Zarsky
`
`Park
`
`
`
`2.
`Statutory Grounds on Which the Challenge is based
`Ground Statute Claim(s)
`Prior Art
`1
`§103
`1-7, 23-30
`Simon in view of Edoute
`
`2
`
`3
`
`§103
`
`§103
`
`1-7, 23-30
`
`1-7, 23-30
`
`Simon in view of Edoute and Park
`
`Burnett-’870 in view of Park and Zarsky
`
`See §VIII.
`
`
`2 The art predates ’295’s earliest priority date; Petitioner takes no position as to the
`priority claims.
`
`5
`
`

`

`U.S. Patent No. 10,821,295
`Petition for Inter Partes Review
`
`
`V. BACKGROUND
`A.
`’295 Patent
`ʼ295 is directed to combining application of a time-varying magnetic field
`
`with radiofrequency waves, to remodel or improve muscles and adjacent body
`
`regions. ʼ295, Abstract, 2:1–7, 4:12–15, 6:42–49. ’295 recognizes that
`
`“radiofrequency treatment” was one of the “most common methods used for non-
`
`invasive aesthetic applications” and its effect is known to be “based specifically on
`
`heat production in the biological structure.” ’295, 2:17-27.
`
`Both the magnetic field generating device and the radiofrequency electrode
`
`are in the same device. ʼ295, 98:21-29. As shown in Fig. 11a, device 44 includes
`
`magnetic field generating device 45 and RF means 46 applied to a patient’s body
`
`region 43. Id.; Bikson, ¶102.
`
`
`
`6
`
`

`

`
`ʼ295 uses an RF (radiofrequency) source providing radiofrequency waves to an
`
`U.S. Patent No. 10,821,295
`Petition for Inter Partes Review
`
`electrode, to heat a target body region. ʼ295, 25:51–54, 26:13–46, 98:23–26. The
`
`RF means may be a radiofrequency electrode. ’295, 26:24-29. The radiofrequency
`
`electrode is powered by a high frequency (HF) generator. The HF signal may be
`
`transferred via transmatch. ’295, 25:48-55. A balun transformer may also be used
`
`to transform unbalanced signal to balanced signal. ’295, 25:49-50. Bikson, ¶102.
`
`ʼ295’s device may include two circuits generating two magnetic fields.
`
`’295, 5:28-30. The circuits include energy storage devices (i.e., capacitors)
`
`discharging energy to two magnetic field generating coils. ʼ295, 3:31–33, 19:56-
`
`64, 20:23–26.
`
`The coils generate “impulses” (i.e., “magnetic stimulus”) to cause muscle
`
`
`
`7
`
`

`

`
`contractions. ʼ295, 6:66–7:2. Figure 8 shows that these impulses are biphasic and
`
`U.S. Patent No. 10,821,295
`Petition for Inter Partes Review
`
`sinusoidal. Bikson, ¶103.
`
`
`
`ʼ295, Fig. 8, 6:66–7:2, 105:26–29. A “pulse” is defined by the period of treatment
`
`between the beginning of a first impulse and the beginning of a second impulse.
`
`ʼ295, 7:3–6. The magnetic field is applied by the magnetic field device including
`
`the coil. ʼ295, 3:31–33, 8:4–6. Bikson, ¶103.
`
`The device includes a “control unit” to regulate the magnetic field and
`
`radiofrequency generations, and uses a “casing” with a “cooling media” for the
`
`applicators. ʼ295, 10:21–25, 15:1–6, 20:23–26, 25:51–54. Figure 2 shows a cross-
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`section of a magnetic applicator using a “blower 4” that allows better air flow (as
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`indicated by arrows 6) on the lower and upper sides of magnetic field generative
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`8
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`device and thus more efficient heat dissipation. ’295, 9:57-60, 10:36-47. Bikson,
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`¶104.
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`The ’295 patent further discloses positioning applicators on target body
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`regions using a “length adjustable belt.” ʼ295, 11:16–21, Figs. 15–16. Bikson,
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`¶105.
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`B.
`Prosecution History
`’295 issued from U.S. Application No. 16/266,570, filed 2/4/2019. Ex-
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`1003, 1-126. Applicant filed a Preliminary Amendment 2/25/2019, amending
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`claim 1 and adding 29 other claims. Ex-1003, 127–136. Track 1, prioritized status
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`was granted 2/27/2019. Ex-1003, 141–142.
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`Examiner issued an Office Action on 4/18/2019, rejecting pending claims as
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`anticipated by Edoute (US2011/0130618) (“Edoute-’618”) and obvious over
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`Edoute-’618 in view of Hallgren (US3,841,306). Ex-1003, 152-161. The
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`Examiner indicated that Edoute-’618 taught every limitation of independent
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`claim 1, except for “an energy storage device,” and found that it would have been
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`obvious to combine Edoute-’618 with Hallgren’s signal generator including a
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`capacitor—i.e., “an energy storage device.” Ex-1003, 158. Bikson, ¶¶106-107.
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`On 7/18/2019, in response to the Examiner’s rejection, Applicant argued that
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`the Examiner failed to provide any rationale to modify Edoute-’618 in view of
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`Hallgren to “include such an energy storage device.” Ex-1003, 185. Applicant
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`amended independent claim 1 to further recite values for the magnetic field’s
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`repetition rate and magnetic flux density, and applying magnetic field to cause a
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`muscle to contract, and argued that these features were not disclosed in Edoute-
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`’618. Ex-1003, 175, 186-188. The Examiner allowed the claims 11/20/2019. Ex-
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`1003, 210–216. Subsequently, Applicant amended the claims, specification, and
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`figures on 2/20/2020 and 8/21/2020. Ex-1003, 252–262, 373–389. Bikson, ¶108.
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`The table below summarizes, for each issued independent claim, the features
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`Applicant argued as not taught in the prior art during an amendment, and the
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`features Examiner found to be missing in the prior art in allowing the claims. See
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`Ex-1003, 160, 185-188. Bikson, ¶109.
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`Independent
`Claims
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`1
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`8
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`15
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`23
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`
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`Applicant Arguments in an
`Amendment: Prior Art does
`not teach
`Specific repetition rate, specific
`magnetic field density, causing
`muscles to contract
`--
`
`--
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`Specific coil inductance
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`Reasons for Allowance: Prior
`Art does not teach
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`--
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`Specific magnetic flux density
`derivative
`Specific magnetic flux density
`derivative
`--
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`C.
`§325(d) is inapplicable
`All grounds contain at least one of these references—Simon and Park were
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`not before the Examiner. Burnett-’870 and Zarsky were cited in an IDS, but not
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`otherwise identified or applied to reject claims during prosecution. Ex-1003, 226;
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`see Digital Check Corp. v. E-Imagedata Corp., IPR2017-00178, Pap. 6, 12-13
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`(Apr. 25, 2017) (instituting IPR where references were cited in an IDS but “there is
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`no indication in the record that the Examiner rejected any claims based on either
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`reference or that the Examiner or applicant substantively discussed either reference
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`during prosecution”).
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`Edoute was cited in an IDS. A related patent (Edoute-’618) was applied as
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`the primary reference3 in an obviousness combination with another reference,
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`which Applicant argued Edoute-’618 as lacking disclosure for a capacitor and there
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`was no motivation to combine with another reference that discloses a capacitor.
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`The Applicant further distinguished Edoute-’618 on the basis that it does not teach
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`various magnetic field parameters and applying magnetic field causing muscles to
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`contract. See §V.B. The Examiner never considered the testimony of Dr. Bikson
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`(Ex-1002) regarding these references. Ex-1003.
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`Importantly, the Examiner failed to consider and apply the references and/or
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`combinations presented herein that teach the recited features and rationale
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`Applicant argued, or Examiner found, to be missing in the prior art. Both Simon
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`and Burnett-’870, applied here as primary references in separate grounds, disclose
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`a capacitor (i.e., the recited “energy storage device”), which Applicant argued to be
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`missing in Edoute-’618. See §V.B. Referring to the table in §V.B above, Simon
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`and Burnett-’870 disclose the various magnetic field parameters and applying
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`magnetic field to cause muscles to contract, which Applicant argued to be missing
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`in Edoute-’618. Id. The Examiner erred by (1) applying Edoute-’618 as the
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`3 Here, Edoute is applied as a secondary reference to Simon that was not before
`the Examiner.
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`primary reference, and (2) never combining Simon in view of Edoute-’618. The
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`Examine further erred by failing to consider that the recited very broad range of
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`coil inductance was known and conventional and within a POSITA knowledge.
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`See §VIII. Simon and Burnett-’870 further disclose the recited magnetic flux
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`density derivative, which the Examiner found to be missing in prior art. Id.
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`Moreover, Zarsky discloses a balun transformer and a transmatch recited in
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`dependent claims. Id. Park provides the rationale not before the Examiner on
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`why a POSITA would modify a magnetic device to incorporate the teachings of
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`radiofrequency electrode and application in a combined treatment. Id.
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`Accordingly, the “same or substantially the same art or arguments” were not
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`previously presented to the Office during prosecution. Thorne Research v.
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`Trustees of Dartmouth College, IPR2021-00491, Pap. 18, *8-9 (PTAB Aug. 12,
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`2021) (granting institution; finding first prong of Advanced Bionics not satisfied
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`when prior art reference considered by Examiner was combined with references
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`not cited during prosecution); Advanced Bionics, LLC v. Med-El
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`Elektromedizinische Gerate GMBH, IPR2019-01469, Pap. 6, *8-9.
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`VI. LEVEL OF ORDINARY SKILL IN THE ART
`On or before 7/1/2015, a POSITA would have had a bachelor’s degree in
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`biomedical engineering, electrical engineering, physics, or related field, and two or
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`more years of professional experience working with the design, development,
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`and/or use of devices that apply electromagnetic energy to stimulate biological
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`tissue. Additional graduate education could substitute for professional experience,
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`or significant experience in the field could substitute for formal education. Bikson,
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`¶¶1-40.
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`VII. CLAIM CONSTRUCTION
`Claim terms subject to IPR are to be construed according to the Phillips
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`standard applied in district court. §42.100(b). Petitioner applies the plain and
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`ordinary meanings of terms. Only terms necessary to resolve the controversy must
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`be construed. Nidec Motor v. Zhongshan Broad Ocean Motor, 868 F.3d 1013,
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`1017 (Fed. Cir. 2017). Bikson, ¶¶110-111.
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`VIII. GROUNDS OF UNPATENTABILITY
`A. Ground 1: Claims 1-7, 23-30 are rendered obvious by Simon in
`view of Edoute
`1.
`Simon Overview
`Simon discloses a magnetic stimulator used to deliver “energy” to “target
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`tissue,” e.g., for muscle “[r]ehabilitation.” Simon, Title, Abstract, [0002], [0197].
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`Simon, Fig. 5, [0103]. Figures 3A-3D (annotated) show Simon’s stimulator
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`with two applicators situated within a “housing,” each applicator containing a
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`“coil” that generates a time-varying magnetic field when a capacitor is
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`“discharged.” Simon, [0012], [0045], [0047], [0098]. Bikson, ¶¶112-114.
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`Each coil “induces an electromagnetic field” to apply “electrical impulses”
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`to 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, ¶115.
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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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`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, ¶116.
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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
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`
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`for the stimulation signal including power level, frequency, pulse amplitude, and
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`repetition rate. Simon, [0059], [0063]-[0064], [0104]. Bikson, ¶118. Moreover,
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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, ¶¶117-120.
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`
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`Simon discusses the “Agilent 33522A Function/Arbitrary Waveform
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`Generator,” which is a HF (30MHz) generator—see Simon [0057], Bikson ¶121—
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`but to the extent argued Simon lacks a detailed disclosure of a high-frequency
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`generator and radiofrequency electrode configured to apply radiofrequency waves
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`to a patient, heating tissue, a POSITA would have found it obvious to modify
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`Simon’s device to do so for the reasons discussed below in §VIII.A.3; VIII.D—
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`e.g., as the ’295 patent concedes, RF stimulation was known. ’295, 2:17-27.
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`Indeed, it was also well-known and conventional that RF-and-magnetic treatments
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`provided a complementary effect to increase skin rejuvenation, and may reduce
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`side effects compared to separate treatments. See, e.g., Edoute, [0196]-[0197];
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`Park, [0029]-[0030], [0034]-[0036] (describing benefits when combining
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`radiofrequency-and-magnetic treatment). Such modification would predictably
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`work and provide the expected functionality given that Simon already discloses a
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`device with applicators to provide tissue treatment, and radiofrequency electrodes
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`may be utilized within the applicators. Simon, [0012], [0045], [0047], [0098].
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`Bikson, ¶¶121.
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`2.
`Edoute Overview
`Edoute is directed to a device for “simultaneously emit[ting] RF and
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`magnetic pulses” to target body regions for e.g., “muscle contractions.” Edoute,
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`Abstract, [0328], [0243]. Edoute’s device contains electrodes 41, each containing
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`a “coil” serving as a “pulsed electromagnetic frequency generator (2);” electrodes
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`are adapted both to “provid[e] electromagnetic pulses…[and] apply[] heat” via
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`“RF radiation” to a “region of a patient’s skin”:
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`
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`Edoute, Figs. 1B, 2, [0015]-[0017], [0098]-[0099], [0197]-[0198]; [0129]-[0130]
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`(various pulse frequencies and durations, e.g., 16 or 25Hz; 5ms duration.) Bikson,
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`¶122. RF/heat is applied via the “electrodes”—“Radio Frequency” is defined as
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`frequencies of 3Hz-30GHz. Edoute, [0021]-[0023], [0165].
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`Edoute, Fig. 5 (color-annotated).
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`
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`Edoute describes that RF/heating of tissue via electrodes causes “tissue
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`injury” promoting collagen fibers and resulting in “o