BTL Healthcare Technologies A.S.

Patent Trials and Appeals Board

Feb 8, 2022

IPR2021-01282 (P.T.A.B. Feb. 8, 2022)

Trials@uspto.gov Paper 8 571-272-7822 Entered: February 8, 2022 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD LUMENIS BE LTD.,1 Petitioner, v. BTL HEALTHCARE TECHNOLOGIES A.S., Patent Owner. IPR2021-01282 Patent 10,632,321 B2 Before BARBARA A. PARVIS, ZHENYU YANG, and DAVID COTTA, Administrative Patent Judges. PARVIS, Administrative Patent Judge. DECISION Denying Institution of Inter Partes Review 35 U.S.C. § 314 1 Further to Petitioner’s request, we have changed the case caption to reflect that Lumenis Be Ltd., is the successor-in-interest of Lumenis Ltd. Paper 5. IPR2021-01282 Patent 10,632,321 B2 2 I. INTRODUCTION The predecessor-in-interest of Lumenis Be Ltd. (“Petitioner”), Lumenis Ltd., filed a Petition (Paper 2 (“Pet.”)) requesting inter partes review of claims 15-30 (“challenged claims”) of U.S. Patent No. 10,632,321 B2 (Ex. 1001, “the ’321 patent”), along with the supporting Declaration of Marom Bikson, Ph.D. (Ex. 1002). BTL Healthcare Technologies A.S. (“Patent Owner”), filed a Preliminary Response. Paper 7 (“Prelim. Resp.”). The standard for institution is set forth in 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition and the Preliminary Response shows that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314 (2019); see also 37 C.F.R § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the parties’ contentions and the evidence of record, we conclude Petitioner has not established a reasonable likelihood of prevailing in demonstrating the unpatentability of any challenged claim of the ’321 patent. Accordingly, we do not grant Petitioner’s request and do not institute an inter partes review. II. BACKGROUND A. Real Parties-in-Interest Petitioner names itself, Lumenis Be Ltd., as the real party-in-interest. Pet. 2; Paper 5, 1. Patent Owner names itself and BTL Industries, Inc. as the real parties-in-interest. Paper 4, 1. B. Related Matters As required by 37 C.F.R. § 42.8(b)(2), each party identifies a judicial matter that would affect, or be affected by, a decision in this proceeding. The IPR2021-01282 Patent 10,632,321 B2 3 parties inform us that the ’321 patent was recently, but no longer, involved in the following district court case: BTL Industries, Inc. v. Allergen Ltd., Case No. 1-20-cv-01046 (D. Del.), which was filed August 5, 2020 and is now settled. Pet. 3, Paper 4, 1. The parties additionally identify the following settled proceeding as a related matter: Certain Non-Invasive Aesthetic Body Contouring Devices, Components Thereof, and Methods of Using the Same, Inv. No. 337-TA-1219 (ITC), filed August 5, 2020. Pet. 3; Paper 4, 2. Petitioner further identifies the following post-grant review proceedings: Allergan, Inc. et al v. BTL Medical Technologies SRO et al, PGR2021- 00017 (PTAB, Filed Dec. 14, 2020) (institution denied); and Allergan, Inc. et al v. BTL Medical Technologies SRO et al, PGR2021-00018 (PTAB, Filed Dec. 14, 2020) (institution denied). Pet. 3. The ’321 patent is also the subject of IPR2021-01275. Pet. 2-3; Paper 4, 1. Petitioner challenges claims 1-14 of the ’321 patent in IPR2021-01275 in a separate petition “[d]ue to word-count constraints and the large number of claims.” Pet. 3 (citing Consolidated Trial Practice Guide, 59-61; see also 84 Fed. Reg. 64,280 (Nov. 21, 2019)). Petitioner also has contemporaneously filed petitions for review of related patents as follows: (1) petitions for inter partes review of U.S. Patent No. 10,478,634 B2 (IPR2021-01273 and IPR2021-01280); (2) petitions for inter partes review of U.S. Patent No. 10,709,894 B2 (IPR2021-01278 and IPR2021-01285); (3) petitions for inter partes review of U.S. Patent No. 10,709,895 B2 (IPR2021-01279 and IPR2021-01284); (4) petitions for inter partes review of U.S. Patent No. 10,695,575 B1 (IPR2021-01276 and IPR2021-01283). Paper 4, 1. IPR2021-01282 Patent 10,632,321 B2 4 C. The ’321 Patent The ’321 patent relates to devices and methods using the influence of magnetic and induced electric fields on biological structures. Ex. 1001, 1:22-24. A circuit for providing high power pulses to the stimulating magnetic field generating device is shown in Figure 5b, reproduced below. Figure 5b, above, shows a circuit for providing high power pulses for improved function of a treatment device. Id. at 15:11-12. Figure 5b, above, includes magnetic field generating device 28 and energy storage device 29 connected in series and disposed in parallel to switch 30. Id. at 15:12-15. To provide an energy pulse, controlled shorting of energy source 31 takes place through the switch 30. Id. at 15:16-18. Energy source 31 or switch 30, or alternately both, may be regulated by control unit 115. Id. at 15:23-26. IPR2021-01282 Patent 10,632,321 B2 5 An exemplary embodiment of a magnetic treatment device including two independent magnetic field generating circuits is shown in Figure 12, reproduced below. Figure 12, above, shows an embodiment of the magnetic treatment device including two independent magnetic field generating circuits. Id. at 20:25-27. The circuit shown in Figure 12 above includes magnetic field generating circuit 52 and magnetic field generating circuit 57. Id. at Fig. 12, 20:27-33. Magnetic field generating circuit 52 includes energy source 53, switching device 54, energy storage device 55, and magnetic field generating device 56. Id. at 20:27-30. Magnetic field generating circuit 57 includes energy source 58, switching device 59, energy storage device 60, and magnetic field generating device 61. Id. at 20:30-33. A control unit IPR2021-01282 Patent 10,632,321 B2 6 controls providing energy from the energy storage devices to the coils to generate magnetic impulses by the coils. Id. at 20:58-61. D. Illustrative Claims Petitioner challenges claims 15-30 of the ’321 patent. Pet. 1, 6. Claims 15 and 23 are the independent claims. Claims 16-22 depend, directly or indirectly, from claim 15. Claims 24-30 depend, directly or indirectly, from claim 23. Independent claim 15, reproduced below, is illustrative of the claimed subject matter. 15. [15.pre]2 A treatment device for toning muscles of a patient using time-varying magnetic fields, the treatment device comprising: [15.a] a control unit; [15.b] a first energy storage device; [15.c] a second energy storage device; [15.d] a first applicator, the first applicator comprising: [1.e] a first casing; and [1.f] a first magnetic field generating coil disposed within the first casing; [15.g] a first connecting tube coupling the first applicator to the control unit, wherein the first connecting tube includes a first fluid conduit configured to direct cooling media to the first magnetic field generating coil; [15.h] a second applicator, the second applicator comprising: [1.i] a second casing; [1.j] and a second magnetic field generating coil disposed within the second casing; [15.k] a second connecting tube coupling the second applicator to the control unit, wherein the second connecting tube includes a second fluid conduit configured to direct cooling media to the second magnetic field generating coil; 2 Petitioner’s designations to reference the elements of claim 15 are set forth in brackets. Pet. 15-25. Herein we refer to the elements of claim 15 using Petitioner’s designations. IPR2021-01282 Patent 10,632,321 B2 7 [15.l] a first switching device configured to enable discharge of the first energy storage device to the first magnetic field generating coil; and [15.m] a second switching device configured to enable discharge of the second energy storage device to the second magnetic field generating coil, [15.n] wherein the first and the second switching devices are coupled to the control unit, [15.o] wherein the control unit enables the first and the second switching devices to be synchronously switched, [15.p] wherein the first energy storage device is configured to be discharged to the first magnetic field generating coil such that the first magnetic field generating coil generates an impulse of a first time-varying magnetic field with a magnetic flux density in a range of 0.5 Tesla to 7 Tesla, [15.q] wherein the second energy storage device is configured to be discharged to the second magnetic field generating coil such that the second magnetic field generating coil generates an impulse of a second time-varying magnetic field with a magnetic flux density in a range of 0.5 Tesla to 7 Tesla, [15.r] wherein each impulse of the first and the second time-varying magnetic fields is biphasic, [15.s] wherein the first applicator and the second applicator are configured to be placed in contact with a body region of the patient, the body region comprising a buttocks of the patient or an abdomen of the patient, and [15.t] wherein the first and second time-varying magnetic fields are configured to be applied in trains of magnetic pulses to muscle fibers, neuromuscular plates, or nerves innervating muscle fibers in the body region, the trains of magnetic pulses each having a repetition rate in a range of 1 Hz to 300 Hz, such that muscles of the body region are caused to contract. Ex. 1001, 111:42-112:34. IPR2021-01282 Patent 10,632,321 B2 8 E. Evidence Petitioner relies on the patent document references summarized below. Name Patent Document Exhibit Simon US 2015/0165226 A1 1004 Burnett ’870 US 2014/0148870 A1 1005 Petitioner relies on the non-patent literature reference summarized below. Name Non-Patent Literature Title Author(s) Exhibit Magstim The Guide to Magnetic Stimulation, The Magstim Company (July 2006). Chris Hovey BSc, Reza Jalinous, Ph.D. 1006 F. Asserted Grounds Petitioner asserts that the challenged claims of the ’321 patent are unpatentable based on the following grounds summarized below: Claim(s) Challenged 35 U.S.C. §3 Reference(s)/Basis 15-30 103 Simon 15-30 103 Burnett ’870, Magstim 15-30 103 Simon, Burnett ’870 III. ANALYSIS A. Legal Standards “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is 3 Because the challenged claims of the ’321 patent have an apparent effective filing date on or after March 16, 2013, the 35 U.S.C. §§ 102 and 103 provisions of the Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, §§ 3(b)-3(c), 3(n)(1), 125 Stat. 284, 285-87, 293 (2011) apply and we apply the AIA versions of these statutes. Our application of the AIA law is not an affirmative ruling on the actual effective filing date of this patent. IPR2021-01282 Patent 10,632,321 B2 9 unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) as “requiring [inter partes review] petitions to identify ‘with particularity . . . the evidence that supports the grounds for the challenge to each claim’”); see also 37 C.F.R. § 42.104(b) (requiring a petition for inter partes review to identify how the challenged claim is to be construed and where each element of the claim is found in the prior art patents or printed publications relied upon). That burden never shifts to the patentee. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). Furthermore, Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). A patent claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) when in evidence, objective evidence of nonobviousness.4 Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). B. Level of Ordinary Skill in the Art Petitioner asserts the following: 4 Patent Owner does not present objective evidence of nonobviousness. IPR2021-01282 Patent 10,632,321 B2 10 On or before July 1, 2016, a [person of ordinary skill in the art] POSITA would have had a bachelor’s degree in biomedical engineering, electrical engineering, physics, or [a] 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. Pet. 8-9 (citing Ex. 1002 ¶¶ 1-36). Patent Owner does not provide a response on this issue. See generally Prelim. Resp. On the current record, we find Petitioner’s contentions that the skilled artisan would have had “two or more” years of experience to be too vague as it encompasses skill levels beyond the proposal level without a defined limit. We, therefore, adopt Petitioner’s proposal except we do not adopt the “or more” terminology above. We determine that with our changes Petitioner’s proposal is consistent with the level of skill reflected in the ’321 patent Specification and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). C. Claim Construction We construe the challenged claims by applying the standard used in federal courts, in other words, “the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b),” which is articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). 37 C.F.R. § 42.100(b) (2020). Neither party seeks claim construction other than the plain and ordinary meaning of claim terms. See Pet. 9; see generally Prelim. Resp. Petitioner states “[p]ursuant to §42.104(b)(3), regarding the term ‘control unit,’ the Board has denied institution on Allergan’s PGR IPR2021-01282 Patent 10,632,321 B2 11 determining that the term is not indefinite and does not invoke §112(f).” Pet. 9 (citing Allergan, Inc. et al v. BTL Medical Technologies SRO et al, PGR2021-00017, Paper 16 (PTAB, Filed Dec. 14, 2020) (“Allergan, Paper 16”)). The decision denying institution includes the following: Consistent with Patent Owner’s contentions, the Specification does not treat the “control unit” as simply a black box recitation of any structure capable of performing the claimed function, but rather treats the term as referring to known structures such as a personal computer, a human machine interface includ[ing] or alternatively, a “PD and/or PID controller.” Ex. 1005, 8:57-9:5, 14:34-48, 75:18-20. Consistent with this, Figures 5a and 5b depict control unit 115 as a physical structure positioned between the power supply and switch. Ex. 1005, Figs. 5a, 5b. Because the term “control unit” refers to these known structures it is not a means plus function claim limitation. See Samsung, 948 F.3d at 1354 (finding that claimed “digital processing unit” was not a means plus function limitation where the term referred to “a class of known structures - central processing units - that could be found in any general-purpose computer”). Allergan, Paper 16, 13. Our Decision is consistent with that prior determination. D. Obviousness over Simon-Claims 15-30 Petitioner asserts that claims 15-30 would have been obvious over Simon. Pet. 6. We begin with a summary of Simon, then turn to the parties’ dispute. 1. Simon Simon relates to delivery of energy impulses (and/or fields) to bodily tissues for therapeutic purposes. Ex. 1004 ¶ 2. Simon describes toroidal magnetic stimulation devices, as well as to non-invasive methods for treating medical conditions using energy that is delivered by such devices. Id. IPR2021-01282 Patent 10,632,321 B2 12 Simon’s device is shown in Figure 1, which is reproduced below. Figure 1, above, is a schematic diagram of nerve stimulating/modulating device 300 for delivering impulses of energy to nerves for the treatment of medical conditions. Id. ¶ 54. As shown in Figure 1, stimulating device 300 includes impulse generator 310, power source 320, and control unit 330, respectively. Id. Impulse generator 310 is connected by wires to toroidal-shaped magnetic stimulator coil 340 located within electrically conducting medium 350. Id. ¶¶ 54, 56. Simon illustrates an exemplary electrical voltage/current profile for electrical impulses that are applied to a portion or portions of a nerve in Figure 2, reproduced below. IPR2021-01282 Patent 10,632,321 B2 13 Figure 2, above, illustrates a graph of electrical voltage/current profile 400 with modulating impulse 410 having pulse train 420 shown in the graph with current on the y-axis and time on the x-axis. Id. ¶ 60. Simon describes that pulse generator 310 is implemented using power source 320 and control unit 330 having, for instance, a processor, a clock, a memory. Id. ¶ 60. Pulse generator 310 produces pulse train 420 to stimulator coils(s) 340 that deliver stimulating, blocking and/or modulating impulse 410 to the nerve. Id. Simon’s dual-toroid magnetic stimulator coil is shown in Figures 3A- 3D, which are reproduced below. IPR2021-01282 Patent 10,632,321 B2 14 Figures 3A-3D, above, illustrate dual-toroid magnetic stimulator coil 30 situated within housing 37. Id. ¶¶ 45, 93, 98. Figures 3A-3D, above, illustrate top and bottom views of toroidal magnetic stimulator 30. Id. ¶ 93. Stimulator 30 includes two cylindrical- shaped but interconnected conducting medium chambers 34. Id. ¶ 95, Figs. 3A-3D. Each chamber 34 includes coils of wires 35 wound around toroidal cores 36. Id. at 97. 2. Independent Claim 15 a) Elements 15.g and Element 15.k Elements 15.g and 15.k are reproduced below. [15.g] a first connecting tube coupling the first applicator to the control unit, wherein the first connecting tube includes a first fluid conduit configured to direct cooling media to the first magnetic field generating coil; IPR2021-01282 Patent 10,632,321 B2 15 . . . [15.k] a second connecting tube coupling the second applicator to the control unit, wherein the second connecting tube includes a second fluid conduit configured to direct cooling media to the second magnetic field generating coil; Ex. 1001, 111:52-55, 111:60-64. Petitioner asserts that Simon teaches element 15.g based on Simon’s disclosure that “known cooling solutions existed-‘cool[ing] the coils with flowing water’/‘ferrofluids.’” Pet. 19 (citing Ex. 1004 ¶ 20). Petitioner also provides other evidence of cooling solutions. Id. (citing Ex. 1004 ¶ 20; Ex. 1008, 5:47-54, 9:1-10; Ex. 1009, 6:13-14). Petitioner asserts that a person having ordinary skill in the art “would have been motivated and found it obvious to apply prior art teachings to direct cooling media (e.g., ferrofluid) to the coil of the stimulator as taught in Simon.” Id. (citing Ex. 1002 ¶¶ 133- 136, 78-82). Petitioner’s assertion for element 15.k references and relies on only the assertions for element 15.g with respect to cooling. Pet. 20 (referencing “[15].g]”). Patent Owner responds by contending the following: Simon is directed to “toroidal magnetic stimulation devices, as well as … non-invasive methods for treating medical conditions using energy that is delivered by such devices.” EX1004, ¶2. Toroidal stimulators generate magnetic fields that are confined within its coils and do not penetrate into the patient’s body. EX1004, ¶¶37, 82, 122. Rather, toroidal stimulators produce their effect by generating and applying an electric current at the surface of the patient’s skin, similar to a transcutaneous electrical nerve stimulation (“TENS”) device. EX1004, ¶37. Prelim. Resp. 8. Patent Owner asserts that “Simon explains that a ‘practical disadvantage of [conventional] magnetic stimulator coils is that they IPR2021-01282 Patent 10,632,321 B2 16 overheat when used over an extended period of time, because large coil currents are required to reach threshold electric fields in the stimulated tissue.’” Id. at 15-16 (citing Ex. 1004 ¶ 20). Patent Owner further asserts “[b]y contrast, Simon discloses that toroidal magnetic stimulators require significantly less current than conventional magnetic stimulators, and thus produce little to no heat: ‘[T]oroidal stimulators require only about 0.001-0.1 of the current and produce virtually no heating.’” Id. at 16 (citing Ex. 1004 ¶ 37); see also id. at 38 (citing Ex. 1004 ¶¶ 37, 83) (asserting that Simon “touts that lack of heating is an advantage of [Simon’s] device”). Patent Owner, more specifically, asserts that “Simon discloses two characteristics of stimulator 30 that significantly reduce the current required to operate the stimulator, which, in turn, results in little to no heat generation” including (1) “using toroidal cores/coils” and (2) “using the conducting medium 350.” Id. at 38-39 (citing Ex. 1004 ¶¶ 37, 83). Patent Owner points to Simon’s disclosure that toroidal stimulators “produce virtually no heating” and asserts a person having ordinary skill in the art “would have understood that stimulator 30 is not cooled as described in Simon’s background section, which explains cooling is necessary in conventional stimulators because of heat.” Id. at 39 (citing Ex. 1004 ¶¶ 20, 37). Patent Owner asserts that Petitioner’s arguments as to why a person having ordinary skill in the art would have been motivated to apply known cooling techniques to Simon’s stimulator are deficient because “Petitioner does not address Simon’s express teachings that stimulator 30 produces little to no heat.” Id. (citing Ex. 1004 ¶¶ 37, 56, 83, 184). Simon describes that its “invention is particularly useful for inducing applied electrical impulses that interact with the signals of one or more nerves, or muscles, to achieve a therapeutic result.” Ex. 1004 ¶ 53 (emphasis IPR2021-01282 Patent 10,632,321 B2 17 added). Simon describes that Figure 1 illustrates “a schematic diagram of a nerve stimulating/modulating device 300” (id. ¶ 54) “according to the present invention” (id. ¶ 43). Petitioner relies on Simon’s disclosures relating to its modulating device, rather than prior art devices, for many recitations in claim 15. See, e.g., Pet. 15-16 (relying on Simon’s Figure 1 and stimulating/modulating device 300 for element 15.a), 17-19 (relying on Figures 3A-3D, 4C-4D, and 5 illustrating embodiments of magnetic stimulator coil 340 for element 15.d), 23-24 (relying on Figure 2 for element 15.t). Simon further describes the embodiment shown in Figure 1 as follows: The volume of the container containing electrically conducting medium is labeled in FIG. 1 as 350. Use of the container of conducting medium 350 allows one to generate (induce) electric fields in tissue (and electric field gradients and electric currents) that are equivalent to those generated using current magnetic stimulation devices, but with about 0.0001 to 0.01 of the current conventionally applied to a magnetic stimulation coil. This allows for minimal heating and deeper tissue stimulation. Ex. 1004 ¶ 83. Further, in the Summary of the Invention, Simon describes that its devices “require only about 0.001 - 0.1 of the current and produce virtually no heating.” Id. ¶ 37. We agree with Patent Owner that Simon’s teachings relating to cooling pertain to only commercial available devices described in publications summarized in the Background of the Invention. Ex. 1004 ¶ 20. Simon does not teach cooling the coils with respect to nerve stimulating/modulating device 300 illustrated in Figure 1 or any other embodiment described in accordance with Simon’s invention. IPR2021-01282 Patent 10,632,321 B2 18 We also agree with Patent Owner that Simon’s teachings relating to overheating pertain to only commercial available devices described in publications summarized in the Background of the Invention. Simon distinguishes its devices from those on the basis that Simon’s devices “produce virtually no heating.” Id. ¶ 37. Petitioner’s theory that a person having ordinary skill in the art would have been motivated to apply known cooling techniques to Simonʼs stimulator does not take into account Simon’s disclosures that its stimulators “produce virtually no heating.” Id. We, therefore, determine Petitioner has not shown sufficiently that Simon teaches elements 15.g and 15.k. b) Conclusion-Obviousness of Claim 15 over Simon After consideration of the contentions and the evidence of record, we determine that Petitioner has not shown sufficiently that Simon teaches each recitation of claim 15. Accordingly, we conclude that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing that claim 15 is unpatentable under 35 U.S.C. § 103 as obvious over Simon. 3. Claim 23 Independent claim 23 recites [23.h] a first connecting tube coupling the first applicator to the control unit, wherein the first connecting tube comprises a first fluid conduit coupled to a source of oil, and [23.i] wherein the first fluid conduit is configured to direct the oil to the first magnetic field generating coil such that the first magnetic field generating coil is cooled by the oil; . . . [23.m] a second connecting tube coupling the second applicator to the control unit, IPR2021-01282 Patent 10,632,321 B2 19 [23.n] wherein the second connecting tube comprises a second fluid conduit coupled to the source of oil, and [23.o] wherein the second fluid conduit is configured to direct the oil to the second magnetic field generating coil such that the second magnetic field generating coil is cooled by the oil, Ex. 1001, 113:5-24. For claim 23, Petitioner refers to its arguments and evidence for claim 15. Pet. 26-28. Petitioner’s additional discussion relating to why a person having ordinary skill in the art would have applied known oil-cooling techniques to Simonʼs stimulator pertains to heat dissipation and does not take into account Simon’s disclosures to the contrary, i.e., that its stimulators “produce virtually no heating.” See, e.g., Ex. 1004 ¶ 37. Petitioner’s arguments and evidence for claim 23 do not remedy the deficiencies discussed with respect to claim 15. Accordingly, we conclude that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing that claim 23 is unpatentable under 35 U.S.C. § 103 as obvious over Simon. 4. Dependent Claims16-22 and 24-30 Claims 16-22 depend, directly or indirectly, from claim 15. Claims 24-30 depend, directly or indirectly, from claim 23. Petitioner’s arguments and evidence for dependent claims 16-22 and 24-30 do not remedy the deficiencies discussed with respect to claim 15. Pet. 33-41. Accordingly, we conclude that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing that claims 16-22 and 24-30 are unpatentable under 35 U.S.C. § 103 as obvious over Simon. IPR2021-01282 Patent 10,632,321 B2 20 E. Obviousness over Burnett ’870 and Magstim-Claims 15-30 Petitioner asserts that claims 15-30 would have been obvious over Burnett ’870 and Magstim. Pet. 6. We begin with summaries of Burnett ’870 and Magstim, and then turn to the parties’ dispute. 1. Burnett ’870 Burnett ’870 describes a system for electromagnetic induction therapy that generates a magnetic field focused on a target nerve, muscle, or other body tissue. Ex. 1005 ¶ 21. An embodiment of Burnett ’870’s system is shown in Figure 34 reproduced below. Figure 34 illustrates a schematic view of a system including multiple back applicators placed on a human back, a sensor, and a logic controller. Id. ¶ 56. Figure 34, above, illustrates a profile view of the upper half of a human body with one or more back applicators 350 and sensor 352. Id. ¶ 209. Back applicators 350 and sensor 352 are connected by wires to logic controller 354. See id. Referring to Figure 34, Burnett ’870 discloses that applicators 350 may include multiple coils that are fired sequentially. Id. ¶ 209. Burnett ’870 IPR2021-01282 Patent 10,632,321 B2 21 discloses another variation of back applicator 360 with several coils that are pulsed intermittently. Id. ¶ 210. The applicator may be held on a patient by an ergonomic position element, e.g., a belt. Id. Additionally, coil power line 365 for supplying power or current from logic controller 364 may include “fluid cooling, e.g., air or liquid cooling.” Id. Burnett ’870 discloses a variation of the system, shown in Figure 9B, in which coils 106 are disposed within an abdominal garment. Id. ¶ 114. Figure 9B, above, illustrates shorts 108, including two separate sets of 3 interlocking rings labelled coils 106 that connected to a logic controller (not shown) by connector 110. Id. ¶ 114, Fig. 9B. Burnett ’870’s shorts 108 includes one or more sensors (not shown) that provide feedback to the logic controller. Id. ¶ 113. Marking 112 may be added to one side of shorts 108 to indicate wrap orientation. Id. ¶ 114. 2. Magstim Magstim describes techniques of magnetic stimulation for clinical applications. Ex. 1006, 1.5 Magstim illustrates its magnetic stimulator in Figure 2, reproduced below. 5 Magstim includes two sets of page numbers, specifically, original page numbers and page numbers added by Petitioner. We refer to the original page numbers in Magstim. IPR2021-01282 Patent 10,632,321 B2 22 Figure 2, above, illustrates a block diagram of the Magstim Model 2006 monophasic stimulator including a transformer, charging circuitry, a capacitor, an electronic switch, and a coil. See id. at 4. Magstim discloses that the transformer charges the capacitor under the control of a microprocessor. Id. The capacitor is connected to the coil via an electronic switch when the user wishes to apply the stimulus. Id. Magstim’s coil is illustrated in Figure 3, reproduced below. 6 Magstim describes its Magstim Model 200 or Magstim 200 as a stimulator that was launched in 1986. Id. at 3. IPR2021-01282 Patent 10,632,321 B2 23 Figure 3, above, illustrates a circular coil winding showing the lines of force generated when current flows through the winding. Id. at 5. Magstim discloses that the Magstim 200 is supplied with a single circular coil or a double coil shaped as a butterfly or figure of eight. Id. at 5, 9. Double coils use two windings, normally placed side by side. Id. 3. Independent claim 15 a) Elements 15.b and 15.c: “a first energy storage device” and “a second energy storage device” Petitioner provides a mapping for element 15.b in its claim chart that pertains to elements 15.b and 15.c. Pet. 50-51. For element 15.c, Petitioner refers to its mapping for element 15.b. Id. at 51 (stating “See [15.b]”). We treat Petitioner’s mapping for element 15.b as a mapping for both elements 15.b and 15.c. Patent Owner disputes Petitioner’s mapping asserting that the combination of Burnett ’870 and Magstim lacks two energy storage devices. Prelim. Resp. 44. IPR2021-01282 Patent 10,632,321 B2 24 For completeness, we review each of the assertions in Petitioner’s mapping of elements 15.b and 15.c in sequence. Petitioner starts by pointing to two patents described in the background section of Burnett ’870. Pet. 50 (citing Ex. 1005 ¶¶ 13, 14). One of those patents describes “a magnetic stimulation device which consists of a stimulation coil, a high-voltage capacitor, and a controllable network part.” 1005 ¶ 14 (emphases added). The other patent describes a coil, a body applicator, and “[a] reserve capacitor.” Id. ¶ 13 (emphasis added). Consistent with Patent Owner’s assertions, both patents cited by Petitioner from the background section of Burnett ’870 describe a stimulator with a single capacitor. Next Petitioner asserts that Burnett ’870’s “provisional application[7] discloses using a LoFIT system described in Burnett-’185[8] in its invention.” Pet. 50 (citing Ex. 1023 ¶¶ 1, 2, 20). Consistent with Petitioner’s contentions, the ’720 provisional describes the Low Frequency Induction Therapy (“LoFIT”) system. Ex. 1023 ¶¶ 1-2 (describing treatment “with the use of Low Frequency Induction Therapy (LoFIT)”), 20 (“The LoFIT™ System is currently protected by 3 patents pending and one issued patent: U.S. Pat. No. 6,701,185 entitled ‘Method and apparatus for electromagnetic stimulation of nerve, muscle, and body tissues.’”). The ’720 provisional references U.S. Patent No, 6,701,185 B2 (“Burnett ’185,” Ex. 1024). The portions of the ’720 provisional relied on do not describe details of the LoFIT system. 7 Petitioner references provisional application No. 60/848,720 (“the ’720 provisional,” Ex. 1023). 8 Petitioner references U.S. Patent No, 6,701,185 B2 (“Burnett ’185,” Ex. 1024). IPR2021-01282 Patent 10,632,321 B2 25 Petitioner next asserts “Burnett-’185 discloses incorporating a capacitor in the circuitry of the device, allowing it to be charged, and using a switch to discharge it to the coil.” Pet. 50 (citing Ex. 1024, 6:66-7:2, 7:27- 8:26). Burnett ’185 describes that “[t]he internal circuitry of the logic controller 20 comprises or alternatively consists of a transformer, a capacitor, an inducting coil, a diode, and a switch.” Ex. 1024, 6:66-7:1 (emphasis added). Burnett ’185 further describes “[a] capacitor and a stimulating coil (not shown) are provided in parallel.” Id. at 7:27-28 (emphases added). Throughout the portions of Burnett ’185 relied on by Petitioner, Burnett ’185’s disclosure is limited to a single capacitor. Id. at 7:27-8:26 (describing embodiments having describes “a capacitor” or referring to “the capacitor”). In contrast, Burnett ’185 describes alternative embodiments with multiple coils. See id. at 7:53-54 (describing “[o]ne or more coils or arrays of coils”). In one embodiment, Burnett ’185 describes having a single capacitor and an array of coils 32, which are activated sequentially or simultaneously. Ex. 1024, 7:60-67. Burnett ’185 describes that the sequential activation is accomplished by a switching mechanism. Id. Burnett ’185, more specifically, describes the following: In the other position, the switch prevents the capacitor from discharging to ground and allows the capacitor to be charged. Each coil 32 attached to the logic controller 20 may have its own internal switching mechanism to allow firing of the coil 32 in sequence or to allow the firing of multiple coils simultaneously. Ex. 1024, 7:64-67. Regardless of the number of coils, consistent with Patent Owner’s assertions (Prelim. Resp. 44-50), Burnett ’185’s disclosure is limited to a single capacitor. Id. at 6:66-7:2, 7:27-8:26. Petitioner next asserts that: IPR2021-01282 Patent 10,632,321 B2 26 POSITAs would have been motivated and found it obvious to incorporate capacitors in Burnett-’870’s device based on its reference to the LoFIT system, and its guidance to store energy for the coils, and would have understood to charge the capacitors such that they would be discharged to the coils as was known in the art. Pet. 50 (citing pages 3-4 and Figure 2 of Magstim (Ex. 1006) as supporting evidence). Petitioner’s annotated Figure 2 of Magstim is reproduced below. Figure 2, above, illustrates a block diagram of the Magstim Model 200 monophasic stimulator (Ex. 1006, 4, Fig. 2), which includes Petitioner’s yellow annotation highlighting the capacitor, the electronic switch, and the coil, as well as the flow from the capacitor to the coil via the electronic switch (Pet. 53). Magstim describes that the transformer of Magstim charges the capacitor under the control of a microprocessor. Ex. 1006, 4. Magstim further describes that the capacitor is connected to the coil via the electronic IPR2021-01282 Patent 10,632,321 B2 27 switch that delivers energy to the coil when the user wishes to apply the stimulus. Id. Magstim discloses that the Magstim 200 is supplied with a single circular coil or a double coil shaped as a butterfly or figure of eight. Id. at 5, 9. Below is a picture of the Magstim with a double coil. Figure 13 of Magstim, above, is a photograph of a Magstim 200 magnetic stimulator with a double coil. Id. at 9. Consistent with Patent Owner’s arguments (Prelim. Resp. 44-50), Magstim describes the Magstim 200 as having a single capacitor. Ex. 1006, 4, Fig. 2. The Magstim 200 may operate with a double coil. Id. at 5, 9. Petitioner’s mapping in its claim chart concludes with a list of citations, i.e., “See VIII.B.3. Bikson, ¶¶304-312,” (Pet. 50-51), which refer to a section of the Petition entitled “Motivation to Combine” (id. at 47 (§ VIII.B.3)) and Dr. Bikson’s Declaration, respectively. We turn to the “Motivation to Combine” discussion in the Petition that is cited at the end of Petitioner’s mapping. Pet. 47. Petitioner asserts the following: Because Burnett- ’870 discloses using activating two coils “differentially,” and in view of known teachings to use a capacitor for storing energy for a coil, a POSITA would have recognized Burnett- ’870 as teaching separate energy storage per coil that would allow for independent control of separate IPR2021-01282 Patent 10,632,321 B2 28 coils to provide programmable discharge patterns of pulse channels. It would have been an obvious, “typical,” implementation to double the capacitor and switch for a two- coiled design such that each coil has its own circuitry. A POSITA would have been motivated and found it obvious to apply Magstim’s teaching in implementing Burnett-’870’s stimulation device to charge and discharge the capacitors using switches such that energy would be stored in the capacitors and that the discharge of the capacitors would be controlled to provide power to the coils to generate the time-varying magnetic fields. Bikson, ¶¶292-294. Pet. 47-48. Dr. Bikson’s declaration includes similar testimony. Ex. 1002 ¶ 294. Petitioner is correct that Burnett ’870 describes activating coils “differentially.” Ex. 1005 ¶ 87. In particular, Burnett ’870 describes “[w]hen multiple coils 26 are present, coils 26 may be activated simultaneously or differentially to generate the desired magnetic field.” Id. Burnett ’870, more specifically, describes activating coils differentially as a “firing sequence.” Id. However, the evidence of record does not support that the disclosure of “differential” activation of coils requires separate energy storage per coil. In that regard, we note that Burnett ’870’s description of the differential and sequential activation of coils 26 is similar to the description of activating multiple coils sequentially set forth in Burnett ’185. Compare Ex. 1005 ¶ 87 (“When multiple coils 26 are present, coils 26 may be activated simultaneously or differentially to generate the desired magnetic field.”), with Ex. 1024, 7:64-67 (“Each coil 32 attached to the logic controller 20 may have its own internal switching mechanism to allow firing of the coil 32 in sequence or to allow the firing of multiple coils simultaneously.”). As discussed above, Burnett ’185 describes its stimulator as having a single capacitor. IPR2021-01282 Patent 10,632,321 B2 29 Burnett ’870’s use of multiple coils activated by a single capacitor is also similar to Magstim. Burnett ’870’s coils 26 are within coil wrap 20. Id. Burnett ’870’s coil wrap 20 is shown in Figure 1, reproduced below. Figure 1 of Burnett ’870, above, illustrates coil wrap 20 disposed over ankle 22, which includes one or more conductive coils 26. Id. ¶¶ 77, 79. Burnett ’870 describes that coils 26 “may be a single coil shaped in a simple helical pattern or as a figure eight coil, [or] a four leaf clover coil.” Id. ¶ 79. Burnett ’870’s description of multiple coils 26 as including, for example, a “figure eight coil” (Ex. 1005 ¶ 79) is similar to the description in Magstim of its double coil being a “figure of eight coil” (Ex. 1006, 5). Magstim’s double coil “is supplied standard” with the Magstim 200. Id. at 5-6. The Magstim 200 has a single capacitor. Id. at 4, Fig. 2. Thus, the mere existence of multiple coils does not require multiple capacitors. Interpreting “differential” activation of coils as not requiring multiple capacitors is consistent with the disclosure of Burnett ’870. Burnett ’870 describes that “[t]he electric current that produces the magnetic field by flowing through coils 26 is supplied by programmable logic controller 28, IPR2021-01282 Patent 10,632,321 B2 30 which is connected to coils 26, for example, with a power cord 32.” Id. ¶ 81. Burnett ’870’s description of its coil wrap 20 does not indicate that coil wrap 20 includes a capacitor. See, e.g., id. ¶¶ 77, 79, 81, 87. Petitioner acknowledges that Burnett ’870 “leaves the powering of coils to POSITA.” Pet. 47. Upon consideration of Burnett ’870, including Burnett ’870’s description of “activating two coils ‘differentially’” and the disclosures of Magstim and Burnett ’185 relied on by Petitioner, we are not persuaded that they support using two capacitors or energy storage devices. Instead, the disclosures of Burnett ’870, Burnett ’185, and Magstim are consistent with Patent Owner’s assertions that the Petition demonstrates a teaching of only a single capacitor. We turn to Petitioner’s assertion that “[i]t would have been an obvious, ‘typical,’ implementation to double the capacitor and switch for a two-coiled design such that each coil has its own circuitry.” Pet. 47-48 (citing Ex. 1002 ¶¶ 292-294). Petitioner relies on Dr. Bikson’s declaration testimony as the supporting evidence. Id. Petitioner argues and Dr. Bikson testifies that it “would have been an obvious, ‘typical,’ implementation to double the capacitor and switch for a two-coiled design that such that each coil has its own circuitry.” Pet. 47-48; Ex. 1002 ¶ 294. This statement is not followed by a citation to support what Petitioner and Dr. Bikson consider to be a “typical” implementation. Id. However, immediately preceding this statement, the Petition cites Magstim (page 4 and Figure 2) as an example of the “circuitry of a ‘typical simulator’ to control charging and discharging of a capacitor.” Pet. 47. And immediately following the “typical” statement, Petitioner references applying Magstim’s teaching in Burnett ’870’s device. Id. at 48. As such, we IPR2021-01282 Patent 10,632,321 B2 31 infer that Petitioner relies on Magstim as illustrating a typical implementation. This is problematic for Petitioner because, the cited portions of Magstim do not include two capacitors. See Ex. 1006, 4, Fig 2. Dr. Bikson also testifies “it would have been an obvious design choice to keep the same capacitor-to-coil 1:1 ratio in implementing the two-coiled embodiment of [the] Burnett- ’870 device.” Ex. 1002 ¶ 294. A mere design choice, which does not need to be shown explicitly in the prior art, is generally a minor and obvious choice that solves no stated problem. Cf. In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (“Use of such a means of electrical connection in lieu of those used in the references solves no stated problem and would be an obvious matter of design choice within the skill [in] the art.” (citations omitted)). Furthermore, a finding of obviousness based on design choice is precluded where the difference between the claimed feature and prior art results in a functional difference. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992). Here, the current record supports that adding a capacitor to the two- coiled embodiment of Burnett ’870 is not minor and would result in a functional difference. See e.g., Ex. 1001, 19:60-62 (teaching that an embodiment with multiple energy storage devices offers the benefit of “time independency of the impulses generated by the separate magnetic field generating devices”); 19:65-67 (teaching that an embodiment with multiple energy storage devices offers the benefit of “providing various treatments by a plurality of magnetic field generating devices”); 20:34-37 (disclosing that the “magnetic field generating circuit may include a plurality of energy storage devices providing energy to a magnetic field generating device in order to enable higher energy pulse”). Dr. Bikson’s testimony that “it would have been an obvious design choice to keep the same capacitor-to-coil 1:1 IPR2021-01282 Patent 10,632,321 B2 32 ratio in implementing the two-coiled embodiment of [the] Burnett- ’870 device” (Ex. 1002 ¶ 294) is conclusory and does not take into account whether such a change would result in a functional difference. In addition, Dr. Bikson cites Magstim as supporting a 1:1 capacitor-to-coil ratio, but does not address that Magstim discloses a single capacitor-to-multiple coil ratios, including, for example, a 1:2 capacitor-to-coil ratio. See, e.g., Ex. 1006 (“Single Pulse Systems may be used for cortical or peripheral stimulation with either single circular or double figure of eight coils.”). Accordingly, we are not persuaded that the Petition establishes that the prior art supports maintaining a 1:1 capacitor-to-coil ratio or that doubling the capacitor would be an obvious design choice.9 For the reasons given above, we determine Petitioner has not shown sufficiently that the combination of Burnett ’870 and Magstim teaches elements 15.b and 15.c. b) Conclusion-Obviousness of Claim 15 over Burnett ’870 and Magstim After consideration of the contentions and the evidence of record, we determine that Petitioner has not shown sufficiently that the combination of Burnett ’870 and Magstim teaches each recitation of claim 15. Accordingly, we conclude that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing that claim 15 is unpatentable under 35 U.S.C. § 103 as obvious over the combination of Burnett ’870 and Magstim. 9 Elsewhere in his Declaration, Dr. Bikson testifies regarding U.S. Pat. No. 5,718,662 (Ex. 1033, “Jalinous”), which discloses that its magnetic stimulator comprises two sets of capacitors. Ex. 1033, 2:7-11. Petitioner, however, does not rely on or even cite to these paragraphs in connection with respect to elements 15.b and 15.c. IPR2021-01282 Patent 10,632,321 B2 33 4. Independent Claim 23 Independent claim 23 recites “a first energy storage device” (element 23.b) and “a second energy storage device” (element 23.c). For claim 23, Petitioner refers to its arguments and evidence for claim 15 without supplementation. Pet. 60. Petitioner’s arguments and evidence for claim 23 do not remedy the deficiencies discussed with respect to claim 15. Accordingly, we conclude that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing that claims 23 is unpatentable under 35 U.S.C. § 103 as obvious over Burnett ’870 and Magstim. 5. Dependent Claims 16-22 and 24-30 Each of claims 16-22 depends, directly, or indirectly, from claim 15. Each of claims 24-30 depends, directly or indirectly, from claim 23. Petitioner’s arguments and evidence for dependent claims 16-22 and 24-30 do not remedy the deficiencies discussed with respect to claim 15. Pet. 66- 73. Accordingly, we conclude that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing that claims 16-22 and 24-30 are unpatentable under 35 U.S.C. § 103 as obvious over the combination of Burnett ’870 and Magstim. F. Obviousness over Simon and Burnett ’870-Claims 15-30 As an alternative to obviousness of claims 15-30 over Simon alone, Petitioner asserts that claims 15-30 would have been obvious over Simon and Burnett ’870. Pet. 74-78. Petitioner, however, does not supplement its contentions regarding the cooling features recited in claims 15 and 23. Id. IPR2021-01282 Patent 10,632,321 B2 34 Accordingly, we conclude that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing that claims 15-30 would have been obvious over Simon and Burnett ’870. IV. DISCRETIONARY DENIAL Patent Owner asserts we should exercise our discretion under 35 U.S.C. § 325(d) to deny inter partes review because the Petition presents the same or substantially the same prior art and arguments previously presented to the Office. We need not address Patent Owner’s contentions concerning discretionary denial under § 325(d) because Petitioner has not established a reasonable likelihood of prevailing in demonstrating the unpatentability of any challenged claim of the ’321 patent. V. CONCLUSION We have reviewed the Petition and Preliminary Response, and have considered all of the evidence and arguments presented by Petitioner and Patent Owner. For the foregoing reasons, we conclude that the information presented in the Petition does not establish a reasonable likelihood that Petitioner would prevail in showing that the challenged claims of the ’321 patent are unpatentable. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted. IPR2021-01282 Patent 10,632,321 B2 35 FOR PETITIONER: Scott A. McKeown James L. Davis, Jr. ROPES & GRAY LLP scott.mckeown@ropesgray.com james.l.davis@ropesgray.com FOR PATENT OWNER: Richard D. Coller III Jon E. Wright Richard M. Bemben Lestin L. Kenton Christian Camarce STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C. rcoller-ptab@sternekessler.com jwright-ptab@sternekessler.com rbemben-ptab@sternekessler.com lkenton-ptab@sternekessler.com ccamarce-ptab@sternekessler.com