`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 IPR2021-01284
`Patent No. 10,709,895
`
`___________
`
`
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`
`
`
`
`
`
`U.S. Patent No. 10,709,895
`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
`III.
`FEES PAYMENT .......................................................................................... 4
`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.
`’895 Patent ............................................................................................ 6
`B.
`Prosecution History .............................................................................. 8
`LEVEL OF ORDINARY SKILL IN THE ART ............................................ 8
`VI.
`VII. CLAIM CONSTRUCTION ........................................................................... 9
`VIII. GROUNDS OF UNPATENTABILITY ......................................................... 9
`A.
`Ground 1: Claims 14-29 are rendered obvious by Simon .................... 9
`1.
`Simon Overview ........................................................................ 9
`2.
`Claim Charts ............................................................................ 15
`a.
`Independent Claims 14, 21 ...................................................... 15
`b.
`Dependent Claims 15-23, 25-29 .............................................. 34
`Ground 2: Claims 14-29 are rendered obvious by Burnett ’870
`in view of Magstim............................................................................. 43
`1.
`Burnett-’870 Overview ............................................................ 43
`2.
`Magstim Overview ................................................................... 46
`3.
`Motivation to Combine ............................................................ 49
`
`B.
`
`i
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`U.S. Patent No. 10,709,895
`Petition for Inter Partes Review
`
`4.
`Claim Charts ............................................................................ 51
`Independent Claims 14, 21 ...................................................... 51
`a.
`Dependent Claims 15-20, 22-29 .............................................. 69
`b.
`A. Ground 3: Claims 14-29 are rendered obvious by Simon in
`view of Burnett ’870 .......................................................................... 77
`IX. SECONDARY CONSIDERATIONS .......................................................... 82
`X.
`CONCLUSION ............................................................................................. 82
`
`
`
`
`
`ii
`
`
`
`
`
`Exhibit
`(Ex-)
`1001
`1002
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
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`U.S. Patent No. 10,709,895
`Petition for Inter Partes Review
`
`LIST OF EXHIBITS
`
`Description
`
`U.S. Patent No. 10,709,895 (“’895”)
`Declaration of Dr. Marom Bikson (“Bikson”)
`Prosecution history of U.S. Application No. 16/567,866, which led to
`the issuance of the ’895 (excerpts) (the “’866 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. 10,709,895
`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. 10,709,895
`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
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`1052
`
`1053
`
`1054
`
`1055
`
`1056
`
`U.S. Patent No. 10,709,895
`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. 10,709,895
`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. 10,709,895
`Petition for Inter Partes Review
`
`I.
`
`INTRODUCTION
`Lumenis Ltd. (“Petitioner”) respectfully requests IPR of Claims 14-29
`
`(“Claims”) of U.S. 10,709,895 (“’895”) pursuant to §§311-319 and §42.100.
`
`ʼ895 is directed to electrical stimulation of body tissues using magnetic field.
`
`ʼ895, 1:66–2:7. Its exemplary device includes two applicators placed on a
`
`patient’s body causing tissues to contract, thereby “toning’ them. ’895, 7:18–25,
`
`28:2–7. Figure 12 (annotated) shows each applicator has a circuit that contains a
`
`capacitor to discharge energy to a magnetic field generating coil. ʼ895, 19:41–
`
`20:16. Bikson, ¶¶92-99.
`
`ʼ895 explains that “magnetic methods” were already in use. ʼ895, 2:45–48.
`
`Its purported novelty is to combine technologies of “magnetic field with
`
`
`
`
`
`
`
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`radiofrequency, light, mechanical or pressure source.” ʼ895, 1:66–2:7, 3:10–13.
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`U.S. Patent No. 10,709,895
`Petition for Inter Partes Review
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`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, ¶¶37-91. Simon
`
`discloses a magnetic device with two applicators for stimulating muscles during
`
`rehabilitation. Simon, Abstract, [0053]-[0054], [0197]. Bikson, ¶¶105-116, 296.
`
`Burnett-’870 discloses a device with multiple applicators comprising coils to
`
`generate magnetic field to stimulate muscle. Burnett-’870, Abstract, Fig. 9B,
`
`[0114]. Bikson, ¶¶297-308. Magstim discloses fundamentals of magnetic field,
`
`including parameters and components recited in Claims. Magstim, 1, 3-4. Bikson,
`
`¶¶309-315, 541.
`
`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 (IPR2021-01279)
`
`challenging claims 1-13 of the ’895 patent. Due to word count constraints and the
`
`2
`
`
`
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`large number of claims, requiring 12,838 words in IPR2021-01279 and 13,991
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`U.S. Patent No. 10,709,895
`Petition for Inter Partes Review
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`words in IPR2021-01284, claims 14-29 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 ’895 patent is not the subject of any other co-pending litigation.
`
`However, the ’895 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-
`00015 (PTAB, Filed Dec. 14, 2020) (“Allergan’s PGR”) (PGR was based on
`§112 grounds and §103 grounds primarily based on on-sale bar and public
`use of a device; Institution denied based on Fintiv factors);
` Allergan, Inc. et al v. BTL Medical Technologies SRO et al, PGR2021-
`00016 (PTAB, Filed Dec. 14, 2020) (“Allergan’s PGR”) (PGR was based on
`a different set of §103 grounds than those presented in this Petition;
`Institution denied based on Fintiv factors).
`
`3
`
`
`
`
`
`C. Lead and Back-Up Counsel
`
`U.S. Patent No. 10,709,895
`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. 116610-0002-653. Any additional
`
`fees are also authorized.
`
`IV. REQUIREMENTS FOR IPR
`A. Grounds for Standing
`Pursuant to §42.104(a), Petitioner certifies the ’895 is available for IPR.
`
`4
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`
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`Petitioner is not barred or estopped from requesting IPR challenging Claims on the
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`U.S. Patent No. 10,709,895
`Petition for Inter Partes Review
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`grounds herein.
`
`B.
`Identification of Challenge
`Pursuant to §§42.104(b), Petitioner requests canceling 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. The Examiner never considered the testimony of
`
`Dr. Bikson (Ex-1002) regarding these documents. Ex-1003.
`
`Although the ’895 was previously litigated in the ITC, Petitioner had no
`
`
`2 The art predates ’895’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) were from the same company, the
`respective disclosures are substantially different—Magstim is a guide that teaches
`stimulation principles, techniques, and applications claimed in ’895, while the
`manuals describe product operations.
`
`5
`
`
`
`
`involvement or input to those proceedings, nor any relationship to any party
`
`U.S. Patent No. 10,709,895
`Petition for Inter Partes Review
`
`challenging the patent therein. Invalidity of the ’895 was not decided in the ITC
`
`before the matter was settled. This petition presents unique grounds not in
`
`Allergan’s PGR2021-00016—neither Simon nor Burnett-’870 was asserted; and
`
`Magstim is not applied the same way as in any prior ground,4 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
`14-29
`Simon
`
`2
`
`3
`
`§103
`
`§103
`
`14-29
`
`14-29
`
`Burnett-’870 in view of Magstim
`
`Simon in view of Burnett-’870
`
`See §VIII.
`
`V. BACKGROUND
`A.
`’895 Patent
`ʼ895 is directed to producing a time-varying magnetic field to remodel or
`
`improve muscles. ʼ895, 3:26–29, 3:40–41, 3:48–48–51. ʼ895 describes a device
`
`
`4 The Board denied Allergan’s PGR based on Fintiv Factors. Moreover, Burnett-
`’870 is a patent publication that came ten years after US2003/0158585 (“Burnett
`’585”) relied upon in the PGR. 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
`
`
`
`
`with applicators, positionable on target body regions using an “adjustable belt.”
`
`U.S. Patent No. 10,709,895
`Petition for Inter Partes Review
`
`ʼ895, 12:39–41; 19:17–19, Figs. 15-16. Bikson, ¶¶92-93.
`
`
`
`
`
`The device has a “control unit” to regulate magnetic field parameters, and
`
`uses a “casing” with a “cooling media” for the applicators. ʼ895, 3:35–37, 11:7–
`
`11, 13:60–62, 16:6–10. Figure 12 above illustrates circuits having capacitors,
`
`discharging energy to coils. ʼ895, 20:7–10. Bikson, ¶¶94-95.
`
`The coils generate “impulses” (i.e., “magnetic stimulus”), causing muscle
`
`contractions. ʼ895, 7:18–20; 13:57–59; 15:14-16. Figure 8 illustrate the impulses
`
`are biphasic and sinusoidal:
`
`7
`
`
`
`
`
`U.S. Patent No. 10,709,895
`Petition for Inter Partes Review
`
`
`
`ʼ895, Fig. 8, 7:18–20, 104:31-34. A “pulse” is defined by the period of treatment
`
`between the beginning of a first impulse and the beginning of a second impulse.
`
`ʼ895, 7:22–25. Bikson, ¶¶96-99.
`
`B.
`Prosecution History
`’895 issued from U.S. Application 16/567,866, filed on September 11, 2019.
`
`Ex-1003, 1–137. Track 1, prioritized status was granted. Ex-1003, 142–143. No
`
`substantive, prior-art based rejections were issued and the claims were allowed on
`
`May 18, 2020. Ex-1003, 286–287. Bikson, ¶¶100-101.
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART
`On or before 5/10/2016, POSITAs 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,
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`U.S. Patent No. 10,709,895
`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 Phillips.
`
`§42.100(b). Petitioner applies plain and ordinary meanings. 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 PGRs of related patents (sharing substantially the same
`
`specification) determining that the term is not indefinite and does not invoke
`
`§112(f). PGR2021-00017-ID, 10-16; PGR2021-00020-ID, 10-16.
`
`VIII. GROUNDS OF UNPATENTABILITY
`A. Ground 1: Claims 14-29 are rendered obvious by Simon
`1.
`Simon Overview
`Simon discloses a magnetic stimulator for muscle “[r]ehabilitation.” Simon,
`
`title, [0002], [0197].
`
`9
`
`
`
`
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`U.S. Patent No. 10,709,895
`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, ¶¶104-106.
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`10
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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, ¶¶107.
`
`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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`11
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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. 10,709,895
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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.
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`Simon’s coils generate consecutive “energy impulses” to stimulate tissue:
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`12
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`Simon, Fig. 2, [0002], [0029], [0035]. Simon teaches adjustable parameters for
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`the stimulation signal including frequency, pulse amplitude, and repetition rate.
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`Simon, [0059], [0063]-[0064], [0104]. Bikson, ¶¶109-110.
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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, POSITAs would have found it
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`obvious to modify Simon to use detached applicators because Simon teaches
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`applicators with varying shapes/configurations for different applications based on
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`“anatomical location of the stimulation and determining the appropriate pulse
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`configuration.” Simon, [0031], [0100]-[0102]; Fig. 4C-4D. Simon leaves the
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`exact configuration of the applicators to POSITAs, who would be motivated to
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`have independently-positioned applicators for muscle “rehabilitation” on muscle
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`groups. Simon, [0035], [0197]. 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, POSITAs would have been motivated and found it obvious to ramp
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`13
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`down the current after it has been ramped-up then “set to a level” (Simon, [0123])
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`to mimic muscle contraction and relaxation as was known in the art. See, e.g.,
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`Belanger, 239 (disclosing applying trapezoidal envelope to mimic “gradual build
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`up and relaxation phases” during a “voluntary muscle contraction” for a “smooth”
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`contraction to increase patient comfort); Herbst [0030]; [0047] (“[s]awtooth” with
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`“rise and fall ramp”; “[a]rbitrary waveform”). Simon teaches applying stimulation
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`in a manner avoiding “discomfort,” and once current is increased, it must either be
`
`ramped down gradually or abruptly cut off, such that POSITAs would have had a
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`finite number of options and would have chosen the ramp-down option to
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`gradually relax the muscle. Simon, [0016]. Bikson, ¶¶114, 83-90.
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`To the extent argued Simon lacks disclosure of first/second connecting tubes
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`for flowing oil to first/second applicators, POSITAs would have found it obvious
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`to modify Simon to use connecting tubes in order to cool first/second applicators
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`to avoid coils “overheat[ing]” when used over an extended period, such as for
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`muscle “rehabilitation.” Simon, [0020], [0197]. Simon leaves the exact cooling
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`details to POSITAs, who would have been motivated to use connecting tubes for
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`oil to flow from a source to the applicator and provide cooling. Bikson, ¶¶115, 78-
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`82.
`
`To the extent argued Simon lacks disclosure of applying a magnetic field to
`
`left/right buttocks causing contraction of left/right buttock muscles, POSITAs
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`14
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`
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`would have found it obvious to use Simon’s device on left/right buttock for a
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`wider range of treatment areas, e.g., for muscle “rehabilitation.” Simon, [0029],
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`[0036], [0105], [0197]. Bikson, ¶¶116, 39-67.
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`Such a routine change in configuration of applicators, signal amplitude (that
`
`Simon discloses as “adjustable” ([0063])), cooling tubes, and applications would
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`predictably work and provide the expected functionality. Bikson, ¶¶105-116.
`
`2.
`
`Claim Charts
`a.
`Independent Claims 14, 21
`Claim Language
`Simon
`[14.pre]5
`Simon discloses a treatment device for toning a muscle
`of a patient.
`Simon discloses “[m]agnetic stimulation devices” for
`muscle “rehabilitation,” which POSITAs would have
`recognized as 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 ¶¶61-67.
`Simon’s device induces a “time-varying magnetic field” to
`apply “energy” to a patient’s body region (“abdomen”) to
`produce an “intended beneficial physiological effect.”
`Simon, Abstract, [0015], [0023]-[0024], 0035]-[0036],
`[0053]. Bikson, ¶¶117-118, 39-67.
`Simon teaches a first applicator (e.g., first applicator of
`“stimulator 30”) comprising a first magnetic field
`generating coil (e.g., “first coil”), the first magnetic field
`generating coil having a first inductance in a range of
`500 nH to 1 mH.
`
`[14.a]
`
`
`5 To the extent the preambles are limiting, they are met by the art of record. See
`also Bikson, §§VII-VIII for claim mapping.
`
`15
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`Claim Language
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`U.S. Patent No. 10,709,895
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`Simon
`Simon discloses a “stimulator 30” containing applicators
`and connected to “circuit control box 38”:
`
`Simon, Fig. 5 (annotated); [0103].
`The stimulator has two applicators “that lie side-by-side,”
`each containing a “coil[]” disposed in “its own housing”:
`
`
`
`16
`
`
`
`
`
`Claim Language
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`U.S. Patent No. 10,709,895
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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 “anatomical location of
`the stimulation.” Simon, [0031], [0100]-[0102], Fig. 4C-
`4D.
`Simon leaves it to POSITAs to choose the “desired coil
`inductance,” and using a coil with the broad range of
`inductance was known in the art. Simon, [0099]; see, e.g.,
`Magstim, Table 1 (describing coils with, e.g.,
`13.5μH/16μH). Bikson, ¶¶119-122, 53.
`Simon discloses the first applicator is configured to be
`coupled to a first area of a body region.
`See [14.pre]-[14.a]—Simon discloses the stimulator
`“positioned…on or near a patient's…abdomen…” and cites
`prior art “abdomen” treatment. Simon, [0035], [0105],
`[0175]. Bikson, ¶¶123-124, 39-67.
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`17
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`[14.b]
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`
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`
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`Claim Language
`[14.c]
`
`[14.d]
`
`[14.e]
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`U.S. Patent No. 10,709,895
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`Simon
`Simon teaches a second applicator (e.g., second applicator
`of “stimulator 30”) comprising a second magnetic field
`generating coil (e.g., “second coil”), the second magnetic
`field generating coil having a second inductance in a
`range of 500 nH to 1 mH, and wherein the first
`inductance is equal to the second inductance.
`See [14.pre]-[14.a]—Figures 3-4 of Simon depict same-
`sized applicators with same-sized coils and same
`configurations such that the inductances generated by the
`two coils would be equal. POSITAS would have
`understood, as was known, that coils with the same
`properties have the same inductance. See, e.g., Magstim,
`Table 1.
`To the extent argued that Simon does not disclose this,
`POSITAs would have been motivated and found it obvious
`to operate Simon with equal-inductance coils,
`advantageously causing both sides of the body to undergo
`similar treatments to have same visual appearance. Bikson,
`¶¶125-127, 53, 91.
`Simon discloses the second applicator is configured to be
`coupled to a second area of the body region.
`See [14.c]—Simon discloses coupling applicators to
`different areas of the body such as one on “forearm” for one
`electrode and another on “abdomen.” Simon, [0175].
`It was known to position applicators in different body
`regions. See, e.g., Belanger, 246 (position applicators on
`“two different muscle groups”); Burnett-’870, Fig. 9B,
`[0114]. Bikson, ¶¶128-130, 69-71.
`
`Simon teaches a belt (e.g., “strap, harnesses”) configured
`to be coupled to the first applicator (e.g., first applicator
`of “stimulator 30”) and the second applicator (e.g., second
`applicator of “stimulator 30”), and to hold the first
`applicator to the first area of the body region and the
`second applicator to the second area of the body region.
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`18
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`Claim Language
`
`[14.f]
`
`[14.g]
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`[14.h]
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`[14.i]
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`U.S. Patent No. 10,709,895
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`Simon
`See [14.d]—Simon discloses fixing a stimulator having two
`applicators to a body region (e.g., “abdomen”) with
`“[s]traps, harnesses” (i.e., belt) to “maintain the stimulator
`in position,” holding coils “against the patient.” Simon,
`[0147], [0154], [0168], [0182], [0194].
`It was known to use a belt to hold applicators to two body
`regions. E.g., Burnett-’870, [0007] (“adjustable belt”);
`[0209]. Bikson, ¶¶131-133, 69-75.
`
`Simon discloses the body region comprises an abdomen.
`See [14.e]—Simon’s stimulator may be fixed to “abdomen.”
`Simon, [0035], [0105]. Bikson, ¶¶134-135.
`Simon teaches a first energy storage device (e.g.,
`“capacitor”) having a capacitance in a range of 5 nF to
`100 mF.
`Simon leaves it to POSITAs to choose a capacitor, and
`using a capacitor with the broad claimed range of
`capacitance in a stimulator was known in the art. For
`example, Simon cites Epstein as an exemplary “magnetic
`stimulator[] circuit,” including capacitors with capacitance
`of “at least 50 uF,” (0.05mF). Epstein, 8:19-22; Burnett-
`’585, [0071] (capacitance of “at least 5,000 microfarads”:
`5mF). Bikson, ¶¶136-137, 41-54, 76-77.
`Simon teaches a second energy storage device (e.g.,
`“capacitor”) having a capacitance in a range of 5 nF to
`100 mF.
`See [14.g]—Simon discloses using “a 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].
`Bikson, ¶¶138-139, 76-77.
`Simon discloses a first switching device (e.g., “on/off
`switch”) configured to be selectively switched in order to
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`19
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`Claim Language
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`U.S. Patent No. 10,709,895
`Petition for Inter Partes Review
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`Simon
`discharge energy from the first energy storage device
`(e.g., “capacitor”) to the first magnetic field generating
`coil (e.g., “first coil”) such that the first magnetic field
`genera

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