Trials@uspto.gov
`571-272-7822
`
`Paper 17
`Entered: June 16, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ALLERGAN,INC., ALLERGAN LIMITED, ALLERGAN USA,INC.,
`ZELTIQ AESTHETICS, INC., ZELTIQ IRELAND UNLIMITED
`COMPANY, AND REMEDCO. LTD.,
`Petitioner,
`
`V.
`
`BTLHEALTHCARE TECHNOLOGIESA.S.,!
`Patent Owner.
`
`PGR2021-00021
`Patent 10,695,575 B1
`
`Before JOSLAH C. COCKS, BARBARA A.PARVIS, and DAVID COTTA,
`Administrative Patent Judges.
`
`COTTA,Administrative Patent Judge.
`
`DECISION
`Denying Institution of Post-Grant Review
`35 US.C. § 324
`
`1 Further to Patent Owner’s request, we have changedthe case caption to
`reflect that former patent owner BLT Medical Technologies S.R.O assigned
`the 575 patent to BLT Healthcare Technologies A.S. Ex. 3002.
`
`

`

`PGR2021-00021
`Patent 10,695,575 B1
`
`I.
`
`INTRODUCTION
`
`Allergan, Inc., Allergan Limited, Allergan USA,Inc., Zeltiq
`Aesthetics, Inc., Zeltiq Ireland Unlimited Company, and RemedCo.Ltd.
`(‘Petitioner’) filed a Petition (Paper 1 (“Pet.”)) requesting post-grant review
`of claims 1-29 (“the challenged claims”) of U.S. Patent No. 10,695,575 B1
`(Ex. 1004, “the ? 575 Patent”). The predecessor in interest of BLT
`Healthcare Technologies A.S. (“Patent Owner”), BTL Medical Technologies
`
`S.R.O., filed a Preliminary Response. Paper 9 (“Prelim. Resp.”). With our
`
`authorization (Paper 10), Petitioner filed a Reply to Patent Owner’s
`Preliminary Response (Paper 11) and Patent Ownerfiled a Sur-Reply to
`
`Petitioner’s Reply (Paper 14).
`After considering the Petition, Preliminary Response, Reply, and Sur-
`Reply, as well as all supporting evidence, we determinethe Petition does not
`demonstrate that it is more likely than notthat at least one of the challenged
`claims of the ’575 patentis unpatentable. 35 U.S.C. § 324(a). Thus, we do
`notinstitute post-grant review of the challenged claims of the °575 Patent.
`
`Il.
`
`BACKGROUND
`
`A.
`
`Real Parties-in-Interest
`
`Petitioner identifies as the real parties-in-interest the following:
`
`AbbVieInc., Allergan, Inc., Allergan Limited, Allergan USA,Inc., Zeltiq
`Aesthetics, Inc., Zeltiq Ireland Unlimited Company, and Remed Co.Ltd.
`Pet. 95. Patent Owner namesitself, BTL Industries, Inc., and BLT Medical
`
`Technologies S.R.O.as the real parties-in-interest. Paper 16,1.
`
`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. In
`particular, the parties inform us that the ’575 Patent is asserted in the
`
`2
`
`

`

`PGR2021-00021
`Patent 10,695,575 B1
`following district court case: BTL Industries, Inc. v. Allergen Ltd., Case No.
`1-20-cv-01046 (D. Del.) (“the parallel district court proceeding”), which was
`
`filed August 5, 2020 andis stayed. Pet. 96; Paper 6, 2. The parties
`additionally identify the following proceeding as a related matter: Certain
`Non-Invasive Aesthetic Body Contouring Devices, Components Thereof,
`
`and Methodsof Using the Same, Inv. No. 337-TA-1219 (ITC), filed August
`
`5, 2020 (“the ITC investigation”). Id.
`
`The ’575 Patentis also the subject of PGR2021-00020. Paper3, 1.
`
`Theinstant Petition is the second ranked Petition. Jd. For the reasons given
`
`in our decision denying institution in PGR2021-00020, we concludedthat
`
`the Petition in PGR2021-00020 does not demonstrate that it is more likely
`
`than not that at least one of the challenged claims of the ’575 patentis
`unpatentable. Here, we turn to Petitioner’s second rankedpetition.
`Petitioner also has filed contemporaneously petitions for inter partes
`
`review as follows: (1) a petition for inter partes review of U.S. Patent No.
`
`10,493,293 (IPR2021-00296); and (2) a petition for inter partes review of
`
`U.S. Patent No. 10,478,634 (IPR2021-00312). Petitioner further has filed
`
`contemporaneously petitions for post grant review of U.S. Patent No.
`
`10,709,895 (PGR2021-00015 and PGR2021-00016); U.S. Patent No.
`
`10,632,321 (PGR2021-00017 and PGR2021-00018); U.S. Patent No.
`10,709,894 (PGR2021-00022 and PGR2021-00023); and U.S. Patent No.
`10,695,576 (PGR2021-00024 and PGR2021-00025). Paper 6, 1.
`
`C.
`
`The ’575 Patent
`
`The °575 Patentrelates to “device[s] and methods using the influence
`
`of magnetic and inducedelectric field on biological structure.” Ex. 1004,
`
`1:53-55. A circuit for “providing high powerpulses to the stimulating
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`magnetic field generating device”is shown in Figure 5b, reproduced below.
`
`Td. at 14:31-33.
`
`SO 115 31
`
`Figure 5b
`Figure 5b, above, showsa “circuit for providing high powerpulses for
`improved function of a treatment device.” Jd. at 15:8-9. Figure 5b includes
`“magnetic field generating device 28 and energy storage device 29...
`connected in series and disposedin parallel to switch 30.” Jd. at 15:9-12.
`
`“To provide an energypulse, controlled shorting of energy source 31 takes
`
`place through the switch 30.” Jd. at 15:12-15. “[E]nergy source 31”or
`
`“switch 30,” or alternately both, “may be regulated by control unit 115.” Jd.
`
`at 15:23—26.
`
`An “exemplary embodiment”of a “magnetic treatment device
`
`including two independent magnetic field generating circuits”is shown in
`
`Figure 12, reproduced below. Jd. at 20:48—S0.
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`ic
`
`Figure 12
`Figure 12, above, shows “an exemplary embodimentof the magnetic
`
`treatment device including two independent magnetic field generating
`
`circuits.” Jd. at 20:48—-50. The circuit shown in Figure 12 includes magnetic
`
`field generating circuit 52 and magnetic field generating circuit 57. Jd. at
`
`Fig. 12, 20:47-56. Magnetic field generating circuit 52 includes “energy
`source 53, switching device 54, energy storage device 55, and magnetic field
`generating device 56.” Id. at 20:50—-53. Magnetic field generating circuit 57
`
`includes energy source 58, switching device 59, energy storage device 60,
`
`and magnetic field generating device 61. Jd. at 20:53-56. A control unit
`
`controls provides energy from the energy storage devicesto the coils to
`
`generate magnetic impulses by the coils. Jd. at 21:14-17.
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`D.
`
`Illustrative Claims
`
`Petitioner challenges claims 1-29 of the 575 Patent. Pet. 4. Claims
`
`1, 9, 16, and 24 are the independent claims. Claims 2—8 depend,directly or
`
`indirectly, from claim 1. Claims 10-15 depend, directly or indirectly, from
`
`claim 9. Claims 17—23 depend,directly or indirectly, from claim 16. Claims
`
`25-29 depend,directly or indirectly, from claim 24. Independentclaim 1,
`
`reproduced below,isillustrative of the claimed subject matter.
`
`1.|A method for toning muscles of a patient, comprising:
`positioning a first applicator on the patient,
`the first
`applicator housing a first magnetic field generating coil having
`an inductance;
`independently positioning a second applicator on the
`patient, the second applicator housing a second magnetic field
`generating coil having the same inductanceasthe first magnetic
`field generating coil;
`charginga first energy storage device and a second energy
`storage device;
`discharging the first energy storage device to the first
`magnetic field generating coil such that a first impulse ofa first
`time-varying magnetic field is generated;
`discharging the second energy storage device to the
`second magnetic field generating coil such thata first impulse of
`a second time-varying magnetic field is generated,
`time-varying
`wherein the first
`impulse of the first
`magnetic field and the first impulse of the second time-varying
`magnetic field each have a magnetic flux density in a range
`between 0.1 Tesla and 7 Tesla, and wherein the first impulse of
`the first time-varying magnetic field and the first impulse of the
`second time-varying magnetic field each have an impulse
`duration in a range between 3 us and 3 ms;
`the
`establishing a first pulse duration beginning at
`beginning of the first impulse generated by the first magnetic
`field generating coil and ending at the beginning of a second
`impulse generated by the first magnetic field generating coil,
`whereinthefirst impulse generated by the second magneticfield
`generating coil is generated during the first pulse duration;
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`cooling each of the first and the second magnetic field
`generating coils; and
`applyinga first plurality of impulses generatedbythe first
`magnetic field generating coil and applying a secondplurality of
`impulses generated by the second magneticfield generating coil,
`to muscle fibers, neuromuscular plates, or nerves innervating
`muscle fibers in a body region of the patient to cause muscles of
`the body region to contract such that the muscles are toned.
`
`Ex. 1004, 107:48-108:22.
`
`FE.
`
`Evidence
`
`Petitioner relies on the patent document references summarized in
`
`Table 1 below.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1041
`1
`
`Phillips
`
`- Petitioner additionally relies on the non-patentliterature references
`
`summarized in Table 2 below.
`
`
`
`
`
`
`
`Exhibit
`Non-Patent Literature Title
`
`
`
`Magstim Chris Hovey and|1015The Guide to Magnetic
`
`
`Simulation, The Magstim
`Reza Jalinous
`
`
`Company, Ltd.
`
`
`Effects ofElectrical Muscle John P. Porcari,|1019
`Stimulation on Body
`et al.
`
`
`Composition, Muscle
`Strength, and Physical
`
`Appearance, 16(2) Journal of
`
`Strength and Conditioning
`
`Research, 165-172 (2002).
`
`
`
`
`
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`In addition, Petitioner relies on the Declaration of Dr. Pedro Irazoqui
`
`(Ex. 1023, “Irazoqui Declaration”or “Jrazoqui Dec!.”).
`
`F._Asserted Grounds
`
`Petitioner asserts that the challenged claims of the ’575 Patent are
`
`unpatentable based on the following grounds summarized in Table 3 below:
`
`Claims Challenged_|_35 U.S.C. §
`1-7, 16-18, 22
`Burnett 7585, Burnett 821
`3, 4, 8-15, 19, 20, 23
`Burnett
`’585, Burnett
`°821,
`Burnett °585, Burnett ’821,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`14, 15, 24-29
`1-29
`
`
`
`103
`
`’821,
`°585, Burnett
`Burnett
`Johari, Anderson
`Magstim, Porcari, Jalinous,
`Phillips
`
`I. DISCRETIONARY DENIAL OF THE PETITION
`
`Patent Ownercontendsthat we should exercise our discretion under
`
`35 U.S.C. § 324(a) to deny post-grant review becausethe parallel district
`
`court proceeding involves the sameparties, overlapping claims, and the
`
`sameprior art, and becausethe parallel district court proceeding will outpace
`the instant proceeding. Prelim. Resp. 8-24 (citing, e.g., Apple Inc. v. Fintiv,
`
`Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential,
`
`designated May 5, 2020) (‘“Fintiv’”)). Because we determine that Petitioner
`
`fails to demonstrate that it is more likely than not that it will prevail in
`
`showingthe challenged claims are unpatentable, we need not address Patent
`
`Owner’s contentions concerning discretionary denial.
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`IV. OBVIOUSNESS
`
`Legal Standards
`A.
`A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
`
`differences between the claimed subject matter and theprior art are such that
`
`the subject matter, as a whole, would have been obviousat the time the
`
`invention was madeto a person havingordinary 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 contentofthe priorart;
`
`(2) any differences between the claimed subject matter andthepriorart;
`
`(3) the level of ordinary skill in the art; and (4) when in evidence, objective
`
`evidence of nonobviousness.2_ Graham v. John Deere Co., 383 U.S. 1, 17—
`
`18 (1966).
`
`Level of Ordinary Skill in the Art
`B.
`In determining the level of ordinary skill in the art, various factors
`
`may beconsidered,including the “type of problems encountered in the art;
`prior art solutions to those problems; rapidity with which innovationsare
`made;sophistication of the technology; and educational level ofactive
`
`workersin the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)
`
`(citation omitted). The level of ordinary skill in the art is also reflected by
`the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed.
`
`Cir. 2001).
`
`Petitioner asserts that a person of ordinary skill in the art ““POSA”or
`“POSITA”) at the time of the invention would be a person or group of
`
`* Patent Ownerdoesnot present objective evidence of nonobviousnessat
`this stage of the proceeding.
`
`

`

`PGR2021-00021
`_ Patent 10,695,575 B1
`
`people “familiar with the design, development, and use of devices that apply
`
`electrical energy directly, or indirectly via magneticfields, to the body to
`
`stimulate biological tissue (e.g., brains, spinal cords, nerves, or muscles).”
`
`Pet. 6. Accordingto Petitioner, the POSITA would include:
`
`least a bachelor’s degree in electrical
`(i) a person with at
`engineering, biomedical engineering, physics, or related field of
`study, andat least two years’ experience in academia orindustry
`researching, designing, or developing such devices, and (ii) a
`medical doctor, healthcare provider, researcher, or other person
`having a degree
`in medicine, physiology, neuroscience,
`kinesiology, physical
`therapy, biomechanics, or a related
`discipline and two or more years of using,
`researching,
`designing, or developing such devices.
`Pet. 6-7. At this point in the proceeding, Patent Owner does not challenge
`
`Petitioner’s identification of the POSITA. See generally, Prelim. Resp.
`
`Wefind that the phrases “at least” and “or more”in Petitioner's
`
`proposedidentification of the POSA create a vague, open-ended upper
`
`bound for the level of ordinary skill, and we therefore do not adoptthat
`aspect of Petitioner’s proposal. Accordingly, for purposes ofthis decision,
`
`and based on the current record, we adopt Petitioner’s assessment.of the
`
`level of skill for one of ordinary skill in the art, except withoutthe “at least”
`
`and “or more” phrases. This definition is consistent with the level of skill
`reflected in the specification of the ‘575 patent andthe asserted priorart
`
`references. See Okajima, 261 F.3d at 1355.
`
`C.
`
`Claim Construction
`
`Weinterpret claim terms in accordance with the standard used in
`
`federal district court in a civil action involving the validity or infringement
`
`of a patent. See 37 C.F.R. § 42.100(b) (2020).
`
`10
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`Petitioner asserts that “[t]he term ‘control unit’ is an indefinite means-
`
`plus-function term, as explained in Petitioners’ related petition [PGR2021-
`
`00020].” Pet. 5. Petitioner does not provide a construction for “control
`
`unit” for purposesof the instant proceeding and, instead, contends “[t]o the
`
`extent the term is not held indefinite, the grounds in Section V demonstrate
`
`that the claims reciting a “control unit’ also would have been unpatentable
`
`under Section 103.” Jd. Petitioner also asserts that the term “toned” should
`
`| be construed to mean “an enhanced visual appearance of a body region or
`"muscle caused by induced muscle contractions that strengthen,firm,
`volumize, or tighten the muscle.” Jd. Patent Owner contendsthat
`Petitioner’s reliance on its related petition to address the claim term “control
`
`unit,” is improper. Prelim. Resp. 44-46. Patent Owner doesnot identify
`
`any claim terms for construction.
`
`In view of the issues we address below, we determinethatit is not
`
`necessary to provide an expressinterpretation of any claim term. See Nidec
`
`Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017
`
`(Fed. Cir. 2017).
`
`D.—Grounds 1-4
`
`Petitioner asserts that claims 1—7, 16-18, and 22 would have been
`
`obvious over the combination of Burnett ?585 and Burnett ’821 (Ground1),
`
`claims 3, 4, 8-15, 19, 20, and 23 would have been obvious over the
`
`combination of Burnett 585, Burnett ’821, and Johari (Ground 2), claim 21
`
`would have been obvious over the combination of Burnett ’?585, Burnett
`
`821, Johari, and Johari ’399 (Ground3), and claims 14, 15, and 24—29
`
`would have been obvious over the combination of Burnett ?585, Burnett
`
`821, Johari, and Anderson (Ground 4). Patent Owner’s primary arguments
`
`with respect to these grounds apply equally to all four grounds. Accordingly
`
`11
`
`

`

`PGR2021-00021
`Patent 10,695,575 B1
`
`we addressall four grounds together. Our determination centers on the
`
`parties’ dispute regarding Petitioner’s reason to combine Burnett ’821’s
`
`teaching of cooling capabilities with Burnett ’585’s electromagnetic
`
`stimulator. We begin by briefly summarizing Burnett ’585 and Burnett
`
`821. Wethen turn to the parties’ dispute.
`
`1.
`
`Disclosures ofthe Asserted Art
`
`a)—Burnett ’585
`Burnett °585 discloses “[a]n electromagnetic stimulating system and
`
`components configured to provide stimulation to tissues of the human body,
`
`including ... muscles.” Ex. 1039, Abstract. The system uses an
`
`“ergonomic, body-contoured .
`
`.
`
`. appliance to encase a transducer intended
`
`to deliver pulses of electromagnetic stimulation to targeted regions of the
`
`body.” Jd. According to Burnett °585, the system “includes an array of coils
`
`or a circumferential coil incorporated into a range of body appliances that
`
`use an insulated wrap design such that when the appliance is properly
`
`applied, and a current pulse is generated by the logic controller, an
`
`electromagneticfield is produced by the coils proximate the body area of
`
`interest.” Id. § 49. The coils used in Burnett ’585’s system are “insulated
`
`and placed between inner and outerelectrically insulating layers 2.” Id. ¥ 50;
`
`see also, id. J 80 (“In an embodimenteach coil consists of insulated wire.”);
`
`4 81 (same).
`
`Burnett °585 discloses that its system may be used as a “means of
`
`muscular augmentation outside of the medicalfield by athletes and those
`
`desiring increased muscle mass.” Jd. {| 85.
`
`12
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`Burnett ’821
`b)
`Burnett ’821 discloses “systems and/or methods for electromagnetic
`
`induction therapy.” Ex. 1040, Abstract. Burnett ’821’s systems “may
`
`include one or more conductive coils disposed within or along an
`
`applicator.” Jd. 420. “The coils may be configured to generate a magnetic
`
`field focused on a target nerve, muscle or other bodytissues in proximity to
`
`the coil.” Jd. Burnett °821 discloses that its coils may be cooled, explaining:
`
`In certain variations, the electromagnetic or magnetic induction
`systems or devices described herein may incorporate an air-
`cooled coil wherein the air coolant, e.g., liquid orair, is drawn
`through and/orin between the turns of the inductive coil, in
`direct contact with conductive surfaces of the coil. Drawingair
`or otherfluid throughthe coil prevents the coil from heating up
`to the degree that could damagethe coil and the electronics of a
`device, or expose the patient to excessive temperatures.
`
`Id. § 233.
`
`Analysis
`2.
`Wehave reviewed the argumentsset forth in the Petition and Patent
`
`Owner’s Preliminary Responseas well as the evidence currently of record.
`
`As noted above, we focus our analysis on the parties’ dispute regarding
`
`Petitioner’s reason to combine Burnett ’821’s teaching of cooling
`
`capabilities with Burnett ’585’s teaching of electromagnetic stimulating
`
`devices. We concludethat the current record does notsufficiently support
`
`that a person having ordinary skill in the art would have had reason to
`incorporate Burnett’s ’821’s cooling capabilities in the magnetic stimulation
`
`device of Burnett 7585.
`
`Petitioner contends that Burnett ’585 discloses most of the elements of
`
`the challenged claims of the ’575 patent. However,Petitioner does not
`contend that Burnett ’585 discloses cooling its magnetic field-generating
`
`13
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`coils, as required by each of the independentclaims of the °575 patent. Ex.
`1004, 108:14-15 (claim 1, requiring “cooling eachofthefirst and second
`magnetic field generating coils”), 109:19—20 (claim 9, requiring “cooling the
`first and second magnetic field generating coils with oil”), 110:23-24 (claim
`16, requiring “cooling the first and second magnetic field generating coils”),
`111:52 (claim 24, requiring “cooling both magnetic field generating coils by
`oil”). For these claim elements, Petitioner relies on Burnett 821.
`Petitioner discusses how the combination of Burnett ’585 and Burnett
`°891 discloses the cooling steps recited in the challenged claims twicein its
`Petition, once in connection with claim 1 (which requires only cooling the -
`coils) and once in connection with dependent claim 17 (which requires
`cooling the coils with oil). Petitioner’s proofforall ofthe remaining claims
`relies upon orrefers back to Petitioner’s proof for these two claims.
`Petitioner’s discussion of the cooling step recited in claim 1 reads as
`
`follows:
`
`Burnett ’821 discloses a magnetic stimulation device with
`cooled magnetic coils, using the sameor similar control
`circuitry and applicators as in Burnett ’585. The coolant is
`drawn throughthe coil to prevent “the coil from heating up to
`the degree that could damagethe coil and the electronics of a
`device, or expose the patient to excessive temperatures.”
`EX1040,{ [0233]. The stimulating coils in Burnett °821 can
`deliver magnetic stimulation while the circulating cooling fluid
`cools the coils, which heat during treatment. EX1040, { [0233].
`It would have been obviousto incorporate the cooling
`capabilities of Burnett ’821 with the magnetic stimulation
`device in Burnett ’585 to prevent coil overheating, an issue that
`was well-known to a POSITA. EX1023, { 305.
`Pet. 25-26. Petitioner’s discussion of the step of cooling with oil, as recited
`
`in claim 17 reads as follows:
`
`14
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`Asin Claim 1, Claim 17 requires cooling the first and second
`coils, and thus is disclosed by Burnett ’821 for the reasons
`explained in element 1h. EX1023, § 335. Claim 17 further
`requires that the cooling be performed with anoil. It would
`have been obvious to a POSITA to modify Burnett °585 as
`taught by Burnett ’821 to use an oil as a cooling fluid, given the
`inherent properties making oils desirable for such purposes.
`EX1023, {7 335, 361. Moreover, using the magnetic
`stimulation system at higher intensity and frequency for
`performing muscle toning, as taught by Burnett °585, would
`have motivated a POSITAto removegreater levels of excess
`heat.
`
`Id. at 31. In addition to these assertions, in its introduction to its discussion
`
`of Ground1, Petitioner asserts that Burnett ’821 “provides a knownsolution
`
`for coil overheating in a magnetic stimulation device” by teaching features
`
`including “coil cooling capabilities” and that it would have been obvious“to
`
`combinethe teachings of Burnett ?821 with Burnett ?585 because the two
`
`references disclose the same device with the same type of coils.” Pet. 20,
`
`21.3
`
`Patent Ownerarguesthat “Burnett ’585’s coils are made from
`
`insulated wire” and that “because the coil wires are insulated, Burnett
`
`’585’s coils prevent the passage, transfer, or leakage of heat andelectricity
`during operation.” Prelim. Resp. 55. Patent Ownercontends that
`“Petitioner’s obviousness argumentsare fatally flawed because they don’t
`
`consider these technical aspects of Burnett ’585’s coil design,”i.e., that
`
`3 For completeness, we considerall of Petitioner’s assertions regarding the
`cooling steps together for all claims. Even considering Petitioner’s combined
`assertions, we determine the Petition is deficient because it does not
`sufficiently explain how or whya person havingordinary skill in the art
`would have incorporated Burnett ’821’s cooling capabilities into Burnett
`°585’s insulated coils.
`
`15
`
`

`

`PGR2021-00021
`Patent 10,695,575 B1
`
`Burnett ’585’s coils are insulated. Jd. Patent Ownerasserts that, in view of
`
`this failing, Petitioner does not show how or whya person having ordinary
`skill in the art would have incorporated Burnett ’821’s cooling capabilities
`
`into Burnett ’585’s insulated coils. Jd. at 56-59. On the current record, we
`
`agree with Patent Owner.
`
`ASan initial matter, we agree with Patent Ownerthat Burnett ’585
`
`discloses insulated coils. Ex. 1039 Jf 49-51, 80, 81 (discussed supra
`§ IIL.D.1). Petitioner does not identify, and we do not find, any disclosure in
`Burnett °585 suggesting the use of coils lacking insulation.
`
`Petitioner does not sufficiently explain how it proposes to combine
`
`Burnett ’821’s cooling capabilities into Burnett °585’s insulated coils.
`
`Burnett ’821 discloses a cooling system where “liquid or air, is drawn
`
`through and/orin betweenthe turns of the inductive coil, in direct contact
`
`with conductive surfaces ofthe coil.” Ex. 1040 § 233 (emphasis added).
`
`Burnett ’585 describescoils consisting of insulated wire wrapped multiple
`
`times. Ex. 1039 J 80 (“In alternative embodiments, the wire is wrapped 5,
`10, 20, 40, 75, 100, or 200 times, for example.”). The Petition’s explanation
`
`of how these two disclosures combineto render the claimed features obvious
`
`is conclusory, stating only that “[i]t would have been obviousto incorporate
`the cooling capabilities of Burnett ’821 with the magnetic stimulation device
`
`in Burnett ’585 to prevent coil overheating.” Pet. 26. This statement leaves
`open the question of how Burnett ’821’s cooling system, which cools by
`placing a coolant in “direct contact” with the conductive surfacesof the coil,
`would workin a coil comprised of insulated wire.
`
`16
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`Dr. Irazoqui’s testimony doeslittle to clarify how the coolant would
`
`interact with an insulated wire coil. Dr. Irazoquitestifies that a POSA would
`
`have recognized that a “cooling element could be configured such thata first
`
`and second connecting tube are coupledto the first and second applicator to
`
`providethe fluid source to the cooling element, as Burnett ’821 explicitly
`
`discloses.” Ex. 1023 ¥ 305 (citing Ex. 1040 § 208). In this testimony, Dr.
`
`Irazoqui cites to Burnett ’821’s discussion of Figure 35, which is reproduced
`
`below. Id.
`
`Fig. 35
`According to Burnett ’821, Figure 35 “shows a variation of a back applicator
`
`360 which maybepositioned in proximity to or aligned along the spine.”
`
`Ex. 1040 J 208. “The applicator 360 may include severalcoils that are
`
`pulsed intermittently.” Jd. “In one variation, a coil powerline 365 for
`
`supplying poweror current from the logic controller 364 to coils positioned
`
`in the applicator 360 may include fluid cooling, e.g., air or liquid cooling.”
`
`Id. Although Burnett ’821 describes a coil powerline that supplies fluid to
`an applicator, neither Dr. Irazoqui nor Burnett ‘821 explains how that
`coolant would coolan insulated wire coil within the applicator.
`
`Werecognize that the obviousness inquiry does not ask “whether the
`
`references could be physically combined but whether the claimed inventions
`
`17
`
`

`

`PGR2021-00021
`Patent 10,695,575 B1
`
`are rendered obviousby the teachings of the prior art as a whole.” In re
`
`Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc); see also In re Keller,
`642 F.2d 413, 425 (CCPA 1981) (“[t]he test for obviousness is not whether
`the features of a secondary reference may be bodily incorporated into the
`structure of the primary reference.”); In re Nievelt, 482 F.2d 965, 968
`
`(CCPA 1973) (“Combining the teachings of references does not involve an
`
`ability to combinetheir specific structures.”). However, given the apparent
`
`incompatibility of insulation with a cooling system that works by direct
`
`contact, it was incumbenton Petitioner to explain how Burnett’s 821’s
`coolant system would be incorporated into the magnetic stimulation device
`
`disclosed in Burnett 585. KSR, 550 U.S. 398, 418 (2007) (An assertion of
`
`obviousness “cannot be sustained by mere conclusory statements; instead,
`
`there must be somearticulated reasoning with somerational underpinning to
`
`support the legal conclusion of obviousness.”) (quoting Jn re Kahn, 441 F.3d
`977, 988 (Fed. Cir. 2006). Because Petitioner did not doso,it is not clear
`
`how Petitioner contends the disclosure of Burnett °821 would have been
`
`incorporated into the magnetic stimulation device of Burnett *585.
`
`Patent Ownerarguesthat Petitioner also failed to explain “why a
`
`POSA would have been motivated to incorporate Burnett ?821’s cooling
`
`capabilities into Burnett ’585’s insulated coils.” Prelim. Resp. 57. Patent
`
`Ownercontendsthat “due to its thermal properties, Burnett ?585’s insulated
`
`coils address one of the same issues as Burnett ’821’s cooling capabilities:
`
`the need to prevent patient exposure to excessive temperatures.” Id. at 57—
`58. According to Patent Owner, “Petitioner provides no explanation on why
`
`a POSA would have been motivated to modify Burnett ’585’s insulated coils
`
`to further prevent coil overheating or patient exposure to excessive
`
`temperatures.” Jd. at 58.
`
`18
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`Weagree with Patent Ownerthat Petitioner does notsufficiently
`support that a POSA would have had reason to incorporate Burnett’s *821’s
`cooling capabilities in the magnetic stimulation device of Burnett *585.
`
`Petitioner contends that it would have been obvious to modify Burnett *°585
`
`to “prevent coil overheating.” Pet. 26. As support, Petitioner cites Dr.
`Irazoqui whotestifies that “[u]sing higherintensities and frequenciesfor
`toning as taught by Burnett ’585 would have provided motivation to remove
`greater levels of excess heat.” Ex. 1023 305. Although weagreethat
`preventing overheating and/or removing excess heat would provide reason to
`incorporate a cooling element, Petitioner has not directed us to persuasive
`evidencethat the insulated coils of Burnett ’585 are prone to overheating
`
`and/or generating excess heat. Accordingly, we are not persuadedthat
`Petitioner has sufficiently supported that a POSA would have had reason to
`incorporate Burnett’s ’821’s cooling capabilities in the magnetic stimulation
`
`device of Burnett °585.
`
`3.
`
`Conclusion as to Grounds 1-4
`
`For the reasons discussed above, Petitioner has not provided
`
`persuasive evidence supporting that it would have been obviousto
`incorporate Burnett ’821’s cooling capabilities in the magnetic stimulation
`device of Burnett 585. Because each of the challenged claims requires a
`
`cooling step, we determine that Petitioner has not demonstratedthatit is
`more likely than notthat at least one of the challenged claims is unpatentable
`
`overthe priorart cited in connection with Grounds 1-4.
`
`19
`
`

`

`PGR2021-00021
`Patent 10,695,575 Bl
`
`E.
`
`Ground 5: Obviousness
`
`Petitioner asserts that claims 1-29 would have been obvious over
`
`Magstim,Porcari, Jalinous, and Phillips. Pet. 4. We begin our analysis by
`
`briefly summarizing the priorart Petitioner relies upon.
`
`1._Disclosures ofthe Asserted Art
`
` Magstim
`a)
`Magstim describes “techniques involved in magnetic stimulation” and
`
`provides “details about different stimulator types.” Ex. 1015, 1. A
`
`monophasic simulatoris illustrated in Magstim’s Figure 2, reproduced
`
`below.
`
`120 - Bag-
` Satety
`
`Inteddocks
`
`Figure 2: Block diagram of the Magstim 200"
`monophasic stimulaior
`
`Figure 2 of Magstim illustrates a block diagram of the Magstim monophasic
`
`stimulator. Jd. at 3-4. As shownin Figure 2, Magstim’s stimulator includes
`
`controlcircuitry (i.e., a microprocessor), a transformer, a capacitor, an
`
`electronic switch, and a coil, among other components. Jd. at 3-4, Fig.2.
`
`The microprocessor“accepts information such as the capacitor voltage,
`
`20
`
`

`

`PGR2021-00021
`Patent 10,695,575 BI
`
`powerset by the user, and .
`.
`. safety interlocks within the equipmentto
`ensure proper operation” and controls the transformer charging the
`capacitor. Jd. at 4. “[T]he capacitoris .
`.
`. connectedto the coil via an
`
`electronic switch whenthe user wishes to apply the stimulus.” Jd. °
`
`Magstim also describes a biphasic stimulator, which is shown in
`
`Figure 15 reproduced below.
`
`
`
`Figure15: TheGiStim-system, showing the master unit
`(tap), the staveunit(bottom),and the BiStim module.
`(top ie}
`
`Figure 15 of Magstim, above, is a photograph of Magstim’s biphasic
`simulator “showing the master unit (top) and the slave unit (bottom).” Jd. at
`
`10. Magstim describesthat “[t]he Magstim 220 provides a biphasic pulse,
`
`whichis short and efficient and well suited to bilateral cortical stimulation.”
`
`Id. Magstim further describes that the Magstim 220 “producesa higher
`noise level and is possibly less accurate for cortical stimulation when used
`with a circular coil.” Id.
`
`__Jalinous
`b)
`Jalinous is directed to an “apparatus for magnetically stimulating .. .
`
`neuro-musculartissue by inducing therein electric current using time varying
`
`magnetic fields.” Ex. 1016, 1:3-6. Jalinous describes a magnetic
`stimulator, whichis illustrated in Figure 1 reproduced below.Jd. at 1:59-60.
`
`21
`
`

`

`PGR2021-00021
`
`Patent 10,695,575 Bl
`
`Figure 1 of Jalinous, above,is “a schematic representation of a magnetic
`stimulator.” Jd.
`.
`
`Jalinous’s magnetic stimulator provides “magnetic stimulation of

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