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`SCHWARZ et al.
`Application No. 16/219,724
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`Amendments to the Specification
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`Please replace paragraphs [0094], [00424], [00429], [00438], [00441], [00442], [00512], and
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`[00532] with the following amended paragraphs:
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`[0094] Figure 3a is an illustrative embodimentof a casing of the magnetic applicator. The
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`overview drawing contains casing itself 7, which might contain an outlet 8 preferably placed on
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`upperside of the casing 7. The applicator may further include a handle 49 on the upperside of the
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`casing. The handle[[ 47]]_49 may be used for manual positioning the applicator. A connecting tube
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`9 may not only ensure connection of the applicator with the energy source and/or control unit of
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`magnetic treatment device, but also connection to a source of the fluid; however the conduit of the
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`fluid 10 may also be connected separately.
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`[00424] The central control unit 104 may change the treatment parameters and/or control
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`other parts of the device coupled to it. The method of operation mayincludethe central control unit
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`104 communicating with user interface 105, optical waves generating device 106, power supply[[
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`102]]_103 and/or calibration unit 107. The central control unit 104 may also communicate with a
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`scanning powersupply 108, scanning optics 111, scanning control unit 109, movement assembly
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`110 and/or transmission element 112 located in the scanning unit 102. The scanning unit 102 may
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`further include a magnetic field generating device. The magnetic field generating device may
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`communicate with the base 101.
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`[00429] Calibration unit 107 may be controlled by central control unit 104. Calibration unit
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`107 may check stability of the output and/or wavelength of the optical waves generating device 106.
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`In case of instability, calibration unit 107 may provide one or more humanperceptible signals to the
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`operator. The calibration unit 107 may also provide information to the central control unit[[ 106]]
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`104 which may adjust or correct one or more parameters of the optical waves generating device
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`106. Calibration unit 107 may check input or output parameters of the optical wavesin the scanning
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`optics 111, located in the scanning unit 102. Methodsof operation may includethe calibration unit
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`107 communicating with user interface 105 and/or central calibration unit 104.
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`[00438] Figure 22a showshandheld applicator 114 containing body 206, optical waveguide
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`201, sensor 202 and/or translucent element 204. Flexible optical waveguide 205 may connect the
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`handheld applicator 114 with the[[ case]] base 101. Optical waveguide 201 may be encased by the
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`SCHWARZ et al.
`Application No. 16/219,724
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`body 206 and mayprovide optical path where the optical path leaves the handheld applicator
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`through the translucent element 204. Translucent element 204 may be similar to transmission
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`element 112 of the scanning unit 102.
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`[00441] Handheld applicator 114 may be connected to the scanning unit 102 via attaching
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`mechanism. Figure 23a showsseparated handheld applicator 114 from scanning unit 102. Handheld
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`applicator 114 includes optical waveguide 201 guiding the optical waves (represented by arrow
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`212) encased in the handheld applicator’s body[[ 202]]_206. Furthermoreit contains at least one pin
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`301. In shown exemplary embodiment, the handheld applicator includes two pins 301. Shown part
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`of the scanning unit 102 includes recesses 302 ready for insertion of pins 301, connector 303,
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`sealing element 304, at least one movementelements 305 (e.g. spring), scanning optical waveguide
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`306 and scanning optics 111. Movement element 305 (e.g. spring) may be placed in dust-proof
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`cylinder.
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`[00442] Figure 23b showsconnection of the handheld applicator 114 to the scanning unit
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`102 by connector 303. The sealing element 304 may be movedinside the scanning unit 102 adjacent
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`and/or to direct contact with scanning optical waveguide 306. Asa result, the sealing element 304 is
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`the part of the newly created optical wave path including optical waveguide 201, translucent
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`element 204, sealing element 304 and scanning optical waveguide 306. The optical waves[[ 205]]
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`212 may be transmitted through the newly created wave path of the scanning optics. The movement
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`of the sealing element is provided by moving element 305 (shown as compressed springs).
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`Alternatively, the movement elements 305 may movethe sealing element 304 aside from the optical
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`waveguide.
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`[00512] Shape and dimension of the treatment area may be selected separately. Shapes may
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`be selected from predefined set of shapes of shapes or the shape may be created by the operator
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`and/or device. Additionally, shape may be proposed by device according to chosen body part. Shape
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`of treatment pattern may be created accordingto the picture of the tissue problem captured by
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`camera. After the selection, shape may be further modified by operator and/or patient by dividing
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`the shape into plurality of segments (e.g. smaller surface parts and/or borderlines) and their
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`movement to another shape. The creation of new shape, change of one or more dimensions, division
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`of created shapes and/or movement of segments may be executed using the user interface[[ 106]].
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`SCHWARZ et al.
`Application No. 16/219,724
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`Dimensionsof the treatment area may be in the range of 1x1 cm to 180x180 cm and mayhavearea
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`from 1 cm2 to 32 400 cm?, 15 000 cm’, 10 000 cm? or 2500 cm’. Dimensionsofthe treatment
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`pattern maybe in the range of 0.01 cm? to 5000 cm? or 0.1 cm? to 2000 cm? or 1 cm? to 500 cm”.
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`[00532] Methods of treatment may also include application of a negative pressure before,
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`during and/orafter treatment by the energy. An exemplary handheld applicator capable of providing
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`negative pressure is shown in Figure 27, where the handheld applicator may include one or more
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`cavities 213 formed by walls 207. The tissue[[ 212]]_214 may be suckedinto the cavity 213 by
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`negative pressure generated by a source of negative pressure (not shown). Suitable sources of
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`negative pressure include a vacuum pumplocated inside the device and/or external to the device but
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`fluidly connected to cavity 213. Negative pressure may create a skin protrusion which may move
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`the tissue closer to the lens 210. Negative pressure may also provide an analgesic effect. The
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`negative pressure may be in the range of -100 Pa to -2 MPa, -3000 Pato -400 kPa, or -4000 to -100
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`kPa. Deflection of the tissue caused by negative pressure may be in the range of 0.2 mm to 8 mm or
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`0.5 mm to 60 mm or 1 mm to 50 mm or 1.5 mm to 35 mm.
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`Please add the following new paragraphs[0086.1] after paragraph [0086] of the
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`Specification as-filed, and please renumber the remaining paragraphsaccordingly:
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`[0086.1] The magnetic stimulation device may include at least one energy source, at least
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`one energy storage device (e.g. a capacitor), at least one magnetic field generating device (e.g. a
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`coil) and at least one switching device. The magnetic field generating device may include a core,
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`howeverin a preferred embodiment the magnetic field generating device includes no core. The
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`switching device may be any kind of switch such as diode, MOSFET, JFET, IGBT, BJT, thyristor
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`or a combination of them.
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`Please add the following new paragraphs [0153.1] — [0153.3] after paragraph [0153] of the
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`Specification as-file, and please renumberthe remaining paragraphs accordingly:
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`[0153.1] The magnetic stimulation device may includethe at least one applicator, the at least
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`one energy source and at least two magnetic field generating devices. However, in an alternative
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`embodiment the magnetic stimulation device may include a plurality of applicators and/orplurality
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`SCHWARZ et al.
`Application No. 16/219,724
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`of energy sources. The plurality of applicators may be used for treatmentof at least two cooperating
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`muscle groups with different treatment effects.
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`[0153.2] The benefit of this embodimentis that the movementand/or positioning of the
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`plurality of the applicators may be independent. Hencedifferent parts of the patient’s body may be
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`treated simultaneously. Therefore the total treatment time is reduced and 10 patient’s downtimesare
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`reduced as well.
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`[0153.3] Using a plurality of magnetic field generating devices provides faster 10 treatment.
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`Large and/or different areas maybe treated in shorter time. Using a plurality of applicators allows
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`different areas and/or target biological structures to be stimulated at the sametime.
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`Please add the following new paragraphs [0198.1] — [0198.3] after paragraph [0198] of the
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`Specification as-filed, and please renumber the remaining paragraphsaccordingly:
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`[0198.1] In another aspect of the invention, the treatment by magnetic field may be applied
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`to the target structure simultaneously with the radiofrequency treatment to improveeffects of the
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`electromagnetic treatment inducing heat in the target structure.
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`[0198.2] The simultaneous application of magnet treatment and radiofrequency treatment
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`may be in two modes: a first mode may generate the magnet impulses while radiofrequency
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`treatment is active or another mode maygenerate radiofrequency treatment while the magnet
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`treatmentis not in an active stimulation period,i.e. the period of magnet treatment and
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`radiofrequency treatment alternates. Both modes amplify the resulting effect of the treatment.
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`Therefore the results are achieved in significantly shorter time than the same results achieved by
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`separate applications of the radio frequency and magnet treatments.
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`[0198.3] The simultaneous method of magnet treatment and radiofrequency treatment of the
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`target tissue may increase the peak magnetic componentof the entire treatment resulting in
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`improved heating of the target structure including containing higher water volume, e.g. skin. Due to
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`increased temperature of skin, the production and/or remodeling of collagen and/orelastin fibers
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`may be improved and the skin may be provided with a younger, smoother and enhanced
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`appearance. The effect of overheating the muscle is reduced by the improved blood flow.
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`SCHWARZ et al.
`Application No. 16/219,724
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`Please add the following new paragraph [0200.1] after paragraph [0200] of the Specification
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`as-filed, and please renumber the remaining paragraphsaccordingly:
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`[0200.1] In alternative embodiment the applicator may provide a combination of
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`radiofrequency and magnetic treatment. In one embodiment, the applicator may includeat least one
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`radiofrequency electrode for providing radiofrequency treatment and at least one magnetic field
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`generating device, e.g. a coil, for providing magnetic treatment. In another embodiment, the
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`applicator may includeat least one electrode for providing radiofrequency treatment andat least one
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`magnetic field generating device providing magnetic treatment, wherein the at least one RF source
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`provides energy for both at least one electrode andat least one magnetic field generating device.
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`Please add the following new paragraphs [0202.1] — [0202.6] after paragraph [0202] of the
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`Specification as filed, and please renumber the remaining paragraphsaccordingly:
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`[0202.1] The HF generator may provide HFsignal to the transmatch which may adjust the
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`HF signal to optimize the energy transfer between the treatment device and the patient.
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`[0202.2] Transmatch may optimize the energy transfer to the patient. A function of balun is
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`to transform unbalanced signal to balancedsignal.
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`[0202.3] The magnetic field generating device may be encircled by a plurality of electrodes
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`which are powered by one HF generator.
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`[0202.4] Alternatively, the at least one energy delivery element, e.g. a coil, may be
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`positioned below the at least one electrode. The energy delivery element may be positioned in
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`between the electrode andthe patient.
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`[0202.5] The energy storage device may be designedto be of low resistance value when
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`high-frequencysignal (frequency of RF signal) is provided and/or to be of high resistance when the
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`low-frequency signal (frequency of magnetic signal) is provided. In the preferred embodimentthe
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`energy storage device may conductas short-circuit when powered by high-frequency signal and as
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`infinite resistor when power by low-frequencysignal.
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`[0202.6] The frequency spectra of high-frequency signal used for generating the
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`electromagnetic field may be in the range of ones of kHz to hundreds of GHz, more preferably in
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`the range of 500 kHz to 3GHz, most preferably above 1 MHz around 3.4 or 6.7 or 13.56 or 40.68 or
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`27.12 MHz or 434 MHz or 915 MHzor 2.45 GHz.
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`SCHWARZ et al.
`Application No. 16/219,724
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`Please add the following new paragraph [0211.1] after paragraph [0211] of the Specification
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`as-filed, and please renumber the remaining paragraphsaccordingly:
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`[0211.1] In still another application of the invention, the time-varying magnetic field may
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`also be used for stimulation of neural structure to alleviate pain via central neural system
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`stimulation or via peripheral neural structure. In general, the peripheral neural structure may be
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`stimulated by repetition rates exceeding 100 Hz and/or by envelopes of lowerrepetition
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`frequencies. The repetition rate and magnetic flux density selectively stimulates different neural
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`structures. The pain is alleviated at specific repetition rates, pulse shapes and/or current densities.
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`The pain alleviation effect may be caused by high powertime-varying magnetic field at different
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`levels of neural system.
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`Please add the following new paragraph [0262.1] after paragraph [0262] of the Specification
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`as-filed, and please renumber the remaining paragraphsaccordingly:
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`[0262.1] Neural system includes central neural system and/or peripheral neural system.
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`Central neural system (CNS) includes brain and/or spinal cord.
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`Please add the following new paragraph [0728.1] after paragraph [0728] of the Specification
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`as-filed, and please renumber the remaining paragraphsaccordingly:
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`[0728.1] The temperature in the target tissue may be up to 80 °C, morepreferably in the
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`range of 37 to 60 °C, even more preferably in the range of 39 to 50 °C, most preferably in the range
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`of 42 to 47 °C. The temperature may be adjusted based on the intendeduse, e.g. adipose tissue
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`reduction or collagen production.
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`Atty. Dkt. No. 4387.0160000
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