Trials@uspto.gov
`571-272-7822
`
`Paper 16
`Date: 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 REMED CO. LTD.,
`Petitioner,
`v.
`BTL HEALTHCARE TECHNOLOGIES A.S.,1
`Patent Owner.
`
`PGR2021-00017
`Patent 10,632,321 B2
`
`Before JOSIAH C. COCKS, BARBARA A. PARVIS, and DAVID COTTA,
`Administrative Patent Judges.
`
`PARVIS, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Post-Grant Review
`35 U.S.C. § 324
`
`1 Further to Patent Owner’s request, we have changed the case caption to
`reflect that former patent owner BLT Medical Technologies S.R.O. assigned
`the ’321 patent to BLT Healthcare Technologies A.S. Ex. 3002.
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`PGR2021-00017
`Patent 10,632,321 B2
`
`INTRODUCTION
`I.
`Allergan, Inc., Allergan Limited, Allergan USA, Inc., Zeltiq
`Aesthetics, Inc., Zeltiq Ireland Unlimited Company, and Remed Co. Ltd.
`(“Petitioner”) filed a Petition (Paper 1 (“Pet.”)) requesting post-grant review
`of claims 1–30 (“challenged claims”) of U.S. Patent No. 10,632,321 B2
`(Ex. 1005, “the ’321 Patent”), along with the supporting Declaration of Dr.
`Pedro Irazoqui (Ex. 1023). The predecessor in interest of BLT Healthcare
`Technologies A.S. (“Patent Owner”), BTL Medical Technologies S.R.O.
`filed a Preliminary Response. Paper 8 (“Prelim. Resp.”). With our
`authorization (Paper 9), Petitioner filed a Reply to Patent Owner’s
`Preliminary Response (Paper 10) and Patent Owner filed a Sur-Reply (Paper
`13).
`
`After considering the Petition, the Preliminary Response, Petitioner’s
`Reply, and Patent Owner’s Sur-Reply, as well as all supporting evidence, we
`determine the Petition does not demonstrate that it is more likely than not
`that at least one of the challenged claims of the ’321 patent is unpatentable.
`35 U.S.C. § 324(a). Thus, we do not institute post-grant review of the
`challenged claims of the ’321 Patent.
`
`II.
`
`BACKGROUND
`Real Parties-in-Interest
`A.
`Petitioner identifies as the real parties-in-interest the following:
`AbbVie Inc., Allergan, Inc., Allergan Limited, Allergan USA, Inc., Zeltiq
`Aesthetics, Inc., Zeltiq Ireland Unlimited Company, and Remed Co. Ltd.
`Pet. 100. Patent Owner names itself, BTL Medical Technologies S.R.O., and
`BTL Industries, Inc. as the real parties-in-interest. Paper 15, 1.
`
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`PGR2021-00017
`Patent 10,632,321 B2
`
`Related Matters
`B.
`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 ’321 Patent is asserted in the
`following district court case: BTL Industries, Inc. v. Allergen Ltd., Case No.
`1-20-cv-01046 (D.Del.) (“parallel district court proceeding”), which was
`filed August 5, 2020 and is stayed. Pet. 101; Paper 5, 2. The parties
`additionally identify the following 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 (“the ITC proceeding”). Pet. 101; Paper 5, 2.
`The ’321 Patent is also the subject of PGR2021-00018. Paper 3, 2;
`Paper 5, 1. The instant Petition is the first ranked Petition. Paper 3, 2.
`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.
`10,695,575 (PGR2021-00020 and PGR2021-00021); 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 5, 2.
`
`The ’321 Patent
`C.
`The ’321 Patent relates to device and methods using the influence of
`magnetic and induced electric field on biological structure. Ex. 1005, 1:22–
`24. A circuit for providing high power pulses to the stimulating magnetic
`field generating device is shown in Figure 5b, reproduced below.
`
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`Patent 10,632,321 B2
`
`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.
`An exemplary embodiment of a magnetic treatment device including
`two independent magnetic field generating circuits is shown in Figure 12,
`reproduced below.
`
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`Patent 10,632,321 B2
`
`
`
`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
`controls providing energy from the energy storage devices to the coils to
`generate magnetic impulses by the coils. Id. at 20:58–61.
`
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`PGR2021-00017
`Patent 10,632,321 B2
`
`Illustrative Claims
`D.
`Petitioner challenges claims 1–30 of the ’321 Patent. Pet. 4. Claims 1,
`8, 15, and 23 are the independent claims. Claims 2–6 depend, directly or
`indirectly, from claim 1. Claims 9–14 depend, directly or indirectly, from
`claim 8. Claims 16–22 depend, directly or indirectly, from claim 15. Claims
`24–30 depend, directly or indirectly, from claim 23. Independent claim 1,
`reproduced below, is illustrative of the claimed subject matter.
`1.
`A method for toning muscles of a patient using a treatment
`device that generates time-varying magnetic fields, the method
`comprising:
`charging a first energy storage device and a second energy
`storage device;
`discharging the first energy storage device to a first magnetic
`field generating coil disposed in a first applicator, and
`discharging the second energy storage device to a second
`magnetic field generating coil disposed in a second
`applicator;
`cooling the first magnetic field generating coil and the second
`magnetic field generating coil with an oil;
`placing the first applicator and the second applicator in contact
`with a body region of the patient, the body region of the
`patient comprising a buttocks of the patient or an abdomen
`of the patient;
`causing the first magnetic field generating coil to generate an
`impulse of a first time-varying magnetic field, and causing
`the second magnetic field generating coil to generate an
`impulse of a second time-varying magnetic field, the first
`time-varying magnetic field and the second time-varying
`magnetic field each having a magnetic flux density in a
`range of 0.5 Tesla to 7 Tesla at surfaces of the first and
`second magnetic field generating coils, respectively,
`wherein each impulse of the first time-varying magnetic
`field and each impulse of the second time-varying
`magnetic field is biphasic and sinusoidal,
`wherein the impulse of the first time-varying magnetic
`field is one of a first plurality of consecutive
`
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`the first
`
`time-varying
`
`PGR2021-00017
`Patent 10,632,321 B2
`impulses generated by
`magnetic field,
`wherein the impulse of the second time-varying magnetic
`field is one of a second plurality of consecutive
`impulses generated by the second time-varying
`magnetic field, and
`wherein each of the first plurality of impulses and the
`second plurality of impulses comprises a repetition
`rate in a range of 1 Hz to 300 Hz;
`establishing a pulse of the first time-varying magnetic field,
`wherein the pulse of the first time-varying magnetic field
`comprises the impulse of the first time-varying magnetic
`field and wherein the pulse of the first time-varying
`magnetic field lasts a time period between a beginning of
`the impulse of the first time-varying magnetic field and a
`beginning of a consecutive impulse within the first
`plurality of consecutive impulses generated by the first
`time-varying magnetic field;
`wherein the impulse of the second time-varying magnetic
`field is generated during the first pulse of the first
`time-varying magnetic field; and
`applying the plurality of consecutive impulses of the first time-
`varying magnetic field and the plurality of consecutive
`impulses of the second time-varying magnetic field to
`muscle fibers, neuromuscular plates, or nerves innervating
`muscle fibers in the body region such that a first muscle
`and a second muscle of the body region are caused to
`contract.
`Ex. 1005, 108:12–109:3.
`
`Evidence
`E.
`Petitioner relies on the patent document references summarized in
`Table 1 below.
`Name
`
`Exhibit
`
`1017
`1090
`
`Patent Document
`US 2006/0187607 Al
`WO 2015/179571 Al
`
`Mo
`Errico
`
`
`
`
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`PGR2021-00017
`Patent 10,632,321 B2
`Petitioner relies on the non-patent literature references summarized in
`Table 2 below.
`Name
`Porcari
`
`Author
`John P. Porcari,
`et al.
`
`Exhibit
`1019
`
`Non-Patent Literature Title
`Effects of Electrical Muscle
`Stimulation on Body
`Composition, Muscle
`Strength, and Physical
`Appearance, Journal of
`Strength and Conditioning
`Research 165–172 (2002).
`
`
`
`In addition, Petitioner relies on the Salus Talent Pop device (“Pop”) as
`it was sold and used in 2012. Pet. 21. Petitioner relies on the testimony of
`Kyu Tai Joo (Ex. 1042) as well as a Korean Food and Drug Administration
`(KFDA) approval document (Ex. 1043), user manual (Ex. 1046), and
`brochure (Ex. 1047) as describing the features of Pop and corroborating Mr.
`Joo’s testimony regarding the presence of those features. Id.
`
`Finally, Petitioner relies on the Declaration of Dr. Pedro Irazoqui (Ex.
`1023, “Irazoqui Declaration” or “Irazoqui Decl.”) as supporting that the
`challenged claims are unpatentable.
`
`Asserted Grounds
`F.
`Petitioner asserts that the challenged claims of the ’321 Patent are
`unpatentable based on the following grounds summarized in Table 3 below:
`35 U.S.C. §2
`Claims Challenged
`References/Basis
`15–30
`112(b)
`Indefiniteness
`
`2 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. The ’321 Patent’s filing
`date also is after the effective date set for the AIA’s changes to § 112 and we
`
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`PGR2021-00017
`Patent 10,632,321 B2
`Claims Challenged
`1–30
`1–30
`1–7, 15–19, 21
`8–10, 12, 13, 20
`11, 23–30
`14, 22
`
`
`
`35 U.S.C. §2
`112(a)
`112(a)
`103
`103
`103
`103
`
`References/Basis
`Lack of Written Description
`Lack of Enablement
`On-Sale Bar and Public Use
`Pop
`Pop, Porcari
`Pop, Porcari, Mo
`Pop, Porcari, Mo, Errico
`
`III. DISCRETIONARY DENIAL OF THE PETITION
`Patent Owner contends we should exercise our discretion under
`35 U.S.C. § 324(a) to deny post-grant review because the ’321 patent is
`involved in parallel district court and ITC proceedings involving the same
`parties, claims, grounds, arguments, and evidence as presented in the
`Petition. Prelim. Resp. 3–22 (citing, e.g., Apple Inc. v. Fintiv, Inc., IPR2020-
`00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”)). Because
`we determine that Petitioner fails to demonstrate that it is more likely than
`not that it will prevail in showing the challenged claims are unpatentable, we
`need not address Patent Owner’s contentions concerning discretionary
`denial.
`
`IV. ANALYSIS
`Level of Ordinary Skill in the Art
`A.
`Petitioner asserts the following:
`A person of ordinary skill in the art (“POSITA”) at the
`time of the alleged invention would include a person (or a group
`of people) familiar with the design, development, and use of
`devices that apply electrical energy directly, or indirectly via
`magnetic fields, to the body to stimulate biological tissue (e.g.,
`
`apply the AIA version of that statute. See AIA § 4(e). Our application of the
`AIA law is not an affirmative ruling on the actual effective filing date of this
`patent.
`
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`brains, spinal cords, nerves, or muscles). The skilled artisan’s
`group would include: (i) a person with at least a bachelor’s
`degree
`in electrical engineering, biomedical engineering,
`physics, or related field of study, and at least two years’
`experience in academia or industry 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. 7 (citing Ex. 1023, ¶¶ 1–18; 65–68). Patent Owner does not provide a
`response on this issue. See generally Prelim. Resp.
`On the current record, we find Petitioner’s contention that a person
`having ordinary skill in the art would include persons with “at least” certain
`skill levels to be too vague as it encompasses skill levels beyond the
`proposal level without a defined limit. For the same reason, we further find
`the contentions that the skilled artisan would have had “two or more” years
`of experience to be too vague.
`We, therefore, adopt Petitioner’s proposal except we do not adopt the
`vague 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 by the prior art of record. See Okajima v. Bourdeau,
`261 F.3d 1350, 1355 (Fed. Cir. 2001).
`
`Indefiniteness—Claims 15–30
`B.
`Does “control unit” invoke § 112(f)?
`1.
`Petitioner asserts that “control unit” recited in independent claims 15
`and 23 invokes § 112(f) because “the term ‘unit’ is a nonce word that
`triggers Section 112(f)” and “[t]he prefix ‘control’ does not alter this.” Pet.
`15. Petitioner also asserts that, during prosecution, “the Examiner advised
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`Patent Owner that ‘control unit’ invoked Section 112(f).” Id. at 16 (citing
`Ex. 1012, 23).
`Patent Owner argues that Petitioner’s analysis is conclusory and
`considers the terms “control” and “unit” in isolation from other recitations in
`the claim. Prelim. Resp. 24. Patent Owner also argues the following:
`
`In Samsung, . . . the Federal Circuit held that the term “digital
`processing unit” did not invoke § 112 ¶6 because the term
`“clearly serves as a stand-in for a ‘general purpose computer’ or
`a ‘central processing unit,’ each of which would be understood
`as a reference to structure [and] not simply any device that can
`perform a particular function.” See Samsung, 948 F.3d at 1354.3
`And in Samsung, the court found it relevant that the “digital
`processing unit” was “operably connected to” other structural
`components in the claim. Id. So too here, the claimed “control
`unit” is operably connected to other structural components such
`as the claimed “switching devices” and “applicators.”
`
`Id.
`
`Patent Owner asserts that, as understood in light of the claims and the
`’321 Patent Specification, the term “control unit” comprises “the circuitry
`that controls or regulates the energy delivered to inductive coils” (id. at 26)
`and “circuitry that controls a switch” (id. at 27). Patent Owner further asserts
`“[t]o operate circuit components like the switch SW, control unit 115 must
`also be a physical circuit component.” Id. at 29.
`We start our inquiry with the rebuttable presumption that § 112(f)
`does not apply because “control unit” does not use the word “means.”
`Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015)
`(“[T]he use of the word ‘means’ in a claim element creates a rebuttable
`presumption that § 112[(f)] applies. . . . Applying the converse, [the Federal
`
`3 See Samsung Elec. Am., Inc. v. Prisua Eng’g Corp., 948 F.3d 1342, 1354
`(Fed. Cir. 2020).
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`Circuit has] stated that the failure to use the word ‘means’ also creates a
`rebuttable presumption—this time that § 112[(f)] does not apply.”) (en banc
`in relevant part).
`Our inquiry does not end with the rebuttable presumption. The
`Federal Circuit emphasizes that “the essential inquiry is not merely the
`presence or absence of the word ‘means’ but whether the words of the claim
`are understood by persons of ordinary skill in the art to have a sufficiently
`definite meaning as the name for structure.” Williamson, 792 F.3d at 1348.
`To overcome the presumption that § 112(f) does not apply, the burden is on
`Petitioner to “demonstrate[] that the claim term fails to ‘recite sufficiently
`definite structure’ or else recites ‘function without reciting sufficient
`structure for performing that function.” Id. at 1349; see Advanced Ground
`Info. Sys., Inc. v. Life360, Inc., 830 F.3d 1341, 1347 (Fed. Cir. 2016)
`(explaining that in determining whether the presumption has been rebutted,
`the challenger must establish that the claims are to be governed by § 112(f));
`see also Diebold Nixdorf, Inc. v. Int’l Trade Comm’n, 899 F.3d 1291, 1299–
`1300 (Fed. Cir. 2018) (“[I]n appropriate cases, a party advocating that a
`claim limitation that does not recite the word ‘means’ is subject to § 112[(f)]
`can overcome the presumption against its application solely by reference to
`evidence intrinsic to the patent.”).
`We agree with Patent Owner that Petitioner’s assertion is conclusory.
`Petitioner’s discussion of the claim language is limited to a sentence
`regarding the word “control” and a sentence regarding the word “unit,” with
`each word discussed in isolation of any other claim recitation. Pet. 14–16.
`Petitioner cursorily asserts that the terms “unit” and “configured to” invoke
`§ 112(f) and that “control” adds nothing. Id. Importantly, Petitioner’s
`assertion lacks meaningful discussion of the construction of “control unit” as
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`understood in the context of the ’321 Patent Specification. Id; Robert Bosch,
`LLC v. Snap-On Inc., 769 F.3d 1094, 1099 (Fed. Cir. 2014 (“In undertaking
`this analysis [of whether 112(f) applies], we ask if the claim language, read
`in light of the specification, recites sufficiently definite structure to avoid
`112 ¶ 6.”).
`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 include 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”).
`Regarding Petitioner’s remaining assertion that the prosecution
`history supports that “control unit” invokes § 112(f), Applicant did not take
`a position on the Examiner’s statement during prosecution and did not
`necessarily agree with it. Ex. 1012, 22–24, 50. We agree with Patent Owner
`(Prelim. Resp. 33) that it was not required argue against every potentially
`adverse statement made by the Examiner.
`For the reasons given, we determine that Petitioner has not shown that
`it is more likely than not that “control unit” is a means-plus-function term.
`
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`Even if “control unit” invokes § 112(f), does the ’321 Patent
`2.
`Specification discloses sufficient structure?
`We turn next to whether Petitioner has shown that it is more likely
`than not that the ’321 Patent Specification lacks disclosure of sufficient
`structure for “control unit” recited in independent claims 15 and 23, even if
`that term invokes § 112(f). Petitioner asserts that in claim 15 the “control
`unit” performs the function of “enabl[ing] the first and second switching
`devices to be synchronously switched.” Pet. 17. Petitioner asserts that in
`claim 23 the “control unit” performs the function of “regulat[ing] energy”
`provided to the magnetic field generating coils. Id. Petitioner asserts that the
`’321 Patent Specification does not disclose corresponding structure for those
`claimed functions. Id. at 18. Petitioner acknowledges that the ’321 Patent
`Specification describes a control unit “CU” 115, but argues that the
`disclosure is deficient because it describes “only” what the control unit does,
`“e.g., ‘regulating and/or adjusting,’ without disclosing any corresponding
`structure.” Id. at 18.
`Patent Owner asserts that even if “control unit” is interpreted under
`§ 112(f), the ’321 Patent Specification provides sufficient structure. Prelim.
`Resp. 34. Patent Owner points to the disclosure in the ’321 Patent
`Specification that the control unit’s regulation may be done using a human
`machine interface including “a touchscreen, an audio-visual input/output
`device such as [a] PC including [a] display unit, an input unit and/or a
`graphical user interface.” Id. at 36 (quoting Ex. 1005, 8:61–65) (emphasis
`omitted). Patent Owner also points to the ’321 Patent Specification’s
`description of the control unit opening and closing the switch to control the
`discharge of energy from a capacitor to a magnetic coil to generate a
`magnetic field. Id. at 40 (citing Ex. 1005, 14:36–48). Patent Owner asserts
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`that the ’321 Patent also describes a “trapezoidal envelope” as an example
`algorithm for how to control the magnetic field. Id. at 41 (citing Ex. 1005,
`34:12-31, Fig. 13).
`Structure disclosed in the specification is sufficient if the specification
`“links or associates that structure to the function recited in the claim.”
`Williamson, 792 F.3d at 1352. Where there are multiple claimed functions,
`the specification must disclose adequate corresponding structure to perform
`all of the claimed functions. Id. at 1351–1352.
`For claim 15, Petitioner asserts that the function performed by the
`control unit is as follows: “the control unit enables the first and the second
`switching devices to be synchronously switched.” Pet. 17. For claim 23,
`Petitioner asserts that the functions performed by the control unit are as
`follows:
`“the control unit is configured to regulate energy provided to the
`first magnetic field generating coil such that the first magnetic field
`generates a first plurality of impulses of the first time-varying
`magnetic field” (claim element 23t)
`
`[] “the control unit is configured to regulate energy provided to the
`second magnetic field generating coil such that the second magnetic
`field generates a first plurality of impulses of the second time-
`varying magnetic field” (claim element 23u)
`Id.4
`
`The ’321 Patent Specification links the control unit to regulating the
`switching device and the energy source. Ex. 1005, 14:36–48. The ’321
`
`
`4 We note that Petitioner also identifies functional language in dependent
`claim 26 and states that further recitation is not supported. Petitioner,
`however, does not provide any additional arguments regarding lack of
`written description specifically directed to claim 26 and, instead, discusses
`claims 15 and 23. Pet. 16–22.
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`Patent Specification describes that “the switching devices may be
`synchronized to generate the impulses at one fixed time within the pulse or
`both operation modes may be combined.” Id. at 19:60–67; see also id. at
`20:51–52 (“Both circuits may be set up individually or synchronously.”).
`The ’321 Patent also illustrates an exemplary trapezoidal envelope, which is
`a train of pulses. Id. at 34:12–31, Fig. 13. The ’321 Patent discloses that the
`“treatment parameters” — which include the pulses — may be adjusted by a
`human machine interface. Id. at 8:61–65.
`Petitioner’s analysis that the ’321 Patent Specification’s disclosure is
`deficient is cursory. Petitioner quotes the portion of the ’321 Patent that links
`the control unit to regulating the switching device and the energy source.
`Pet. 19 (citing Ex. 1005, 14:41–48). The Petition, however, lacks discussion
`of other pertinent disclosures, such as those identified by Patent Owner,
`including the description of exemplary human machine interfaces and of the
`exemplary trapezoidal envelope (Ex. 1005, 8:61–65, 34:12–31, Fig. 13), and
`how the disclosures pertain to regulating or adjusting switching. Dr.
`Irazoqui’s testimony that the ’321 Patent Specification does not disclose
`components corresponding to the claimed function also does not take into
`account the disclosures identified by Patent Owner. Ex. 1023 ¶¶ 103–147.
`For the reasons given, we determine that Petitioner has not shown that
`it is more likely than not that the ’321 Patent Specification lacks disclosure
`of sufficient structure for “control unit.”
`
`C. Written Description—Claims 1–30
`Petitioner asserts that independent claims 1, 8, 15, and 23 lack written
`description support in the ’321 Patent Specification. Pet. 76. Petitioner also
`points to the recitation in claims 1, 15, and 23 that “magnetic field
`generating coils” generate impulses of a time-varying magnetic field “having
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`a magnetic flux density in a range of 0.5 Tesla to 7 Telsa.” Id. In claim 8,
`Petitioner points to the recitation that the coils generate impulses of the time-
`varying magnetic field having “an impulse duration in a range of 3 μs to 3
`ms.” Id. Petitioner asserts “for each device or method covered by the claims,
`the POSITA must select values from within claimed ranges—and further
`combine with other unclaimed but necessary operating parameters—to
`generate magnetic field pulses that will cause contractions in abdominal or
`buttocks muscles for toning.” Id. at 77 (emphasis added).
`Patent Owner asserts that Petitioner’s argument is that the ’321 Patent
`Specification does not provide written description support for “toning”
`muscles, but that term appears only in the preamble of the challenged
`claims. Prelim. Resp. 44. Patent Owner asserts that Petitioner does not meet
`its burden to establish a lack of written description because Petitioner does
`not argue that any claim preamble is limiting. Id. Patent Owner asserts that
`even if the preamble is limiting, “the ’321 specification details causing
`muscle contractions and toning.” Id. at 45 (citing Ex. 1005, 22:50–23:2,
`24:46–48, 25:1–3, 25:34–43, 28:66–29:1). Regarding the recitations
`identified by Petitioner in the body of the claim, Patent Owner asserts “the
`’321 specification expressly supports the exact claimed ranges of ‘magnetic
`flux density in a range of 0.5 Tesla to 7 Tesla’ and an ‘impulse duration in a
`range of 3 μs to 3 ms.’” Id. (citing Ex. 1005, 3:31–32, 27:9–11, 27:15–20).
`To satisfy the written description requirement, a patent specification
`must describe the claimed invention in sufficient detail that one skilled in the
`art can reasonably conclude that the inventor had possession of the claimed
`invention at the time of the original filing. See, e.g., Moba, B.V. v. Diamond
`Automation, Inc., 325 F.3d 1306, 1319–1320 (Fed. Cir. 2003). We agree
`with Patent Owner that Petitioner has not shown that the Specification lacks
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`sufficient disclosure to reasonably convey to those skilled in the art that the
`inventor had possession of the claimed invention.
`We agree with Patent Owner that the ’321 Patent Specification
`describes using the method for toning. Ex. 1005, 22:64–23:2 (“The treatment
`effect may be known as contouring circumferential reduction, core
`strengthening, body shaping, body contouring, body sculpting, core shaping,
`muscle forming, muscle shaping skin laxity reduction, muscle strengthening,
`muscle toning, muscle firming, muscle volumization, muscle tightening, e.g.
`butt lifting.” (emphasis added)), 25:1–3 (“The effect may be known as
`muscle strengthening, muscle toning or muscle firming.” (emphasis added)),
`25:42–43 (“Hence effects such muscle volumization, toning, strengthening
`and/or remodeling may be caused.” (emphasis added)), 28:66–29:1 (“With
`the present method muscle contractions induced by the applied magnetic
`flux density may help to tone the muscle providing a more attractive
`appearance.” (emphasis added)). Also, the ’321 Patent Specification
`expressly supports the exact claimed ranges of “magnetic flux density in a
`range of 0.5 Tesla to 7 Tesla” and an “impulse duration in a range of 3 μs to
`3 ms.” Id. at 3:31–32, 27:9–11, 27:15–20.
`We turn to Petitioner’s assertion that “for each device or method
`covered by the claims, the POSITA must select values from within claimed
`ranges—and further combine with other unclaimed but necessary operating
`parameters—to generate magnetic field pulses that will cause contractions in
`abdominal or buttocks muscles for toning.” Pet. 77 (emphasis added).
`Petitioner also asserts that the ’321 Patent fails to disclose a strength-
`duration curve for a muscle to be treated and that describing the ranges
`individually is useless because defining a magnetic field requires selecting
`values for all of the operating parameters in combination. Id. at 77-78.
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`Petitioner’s argument that written description must be provided for
`unclaimed features is misplaced. Furthermore, Petitioner acknowledges that
`this information would have been known to a person having ordinary skill in
`the art. Id. at 77–79.
`For the reasons given, we determine that Petitioner has not shown that
`it is more likely than not that the ’321 Patent Specification lacks written
`description of the invention for claims 1–30.
`
`Enablement—Claims 1–30
`D.
` “To prove that a claim is invalid for lack of enablement, a challenger
`must show . . . that a person of ordinary skill in the art would not be able to
`practice the claimed invention without undue experimentation.” Enzo Life
`Sciences, Inc. v. Roche Molecular Sys., Inc., 928 F.3d 1340, 1345 (Fed. Cir.
`2019) (citations and quotation marks omitted). Factors to be considered in
`determining whether a disclosure would require undue experimentation
`include:
`(1) the quantity of experimentation necessary, (2) the amount of
`direction or guidance presented, (3) the presence or absence of
`working examples, (4) the nature of the invention, (5) the state
`of the prior art, (6) the relative skill of those in the art, (7) the
`predictability or unpredictability of the art, and (8) the breadth of
`the claims.
`In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
`Petitioner asserts that claims 1–30 are unpatenable due to a lack
`enablement. Pet. 81–82. Petitioner asserts that the