UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`LUMENIS BE LTD.,
`Petitioner,
`
`v.
`
`BTL HEALTHCARE TECHNOLOGIES A.S.,
`Patent Owner
`
`____________
`
`Case IPR2022-00126
`
`U.S. Patent No. 10,695,576
`
`____________
`
`DECLARATION OF DR. MAROM BIKSON
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`LUMENIS EX1002
`Page 1
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`TABLE OF CONTENTS
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`I. 
`
`II. 
`
`INTRODUCTION ........................................................................................... 1 
`A. 
`Engagement ........................................................................................... 1 
`B. 
`Background and Qualifications ............................................................. 1 
`C. 
`Basis of My Opinion and Materials Considered ................................... 7 
`D. 
`Legal Standards for Patentability .......................................................... 7 
`1. 
`Obviousness ................................................................................ 7 
`2. 
`Claim Construction ................................................................... 13 
`DESCRIPTION OF THE RELEVANT FIELD AND THE
`RELEVANT TIMEFRAME .......................................................................... 14 
`III.  THE PERSON OF ORDINARY SKILL IN THE RELEVANT FIELD
`IN THE RELEVANT TIMEFRAME ........................................................... 17 
`IV.  TECHNICAL BACKGROUND AND STATE OF THE ART .................... 19 
`A.  Developments in Magnetic Muscle-Stimulation Technology ............ 19 
`1. 
`Problems Discussed in the ʼ576 Patent ..................................... 19 
`2. 
`Stimulation Occurs by Inducing Current in Biological
`Tissue ........................................................................................ 20 
`Stimulation Parameters ............................................................. 21 
`3. 
`Components of a Magnetic Stimulation Device ....................... 26 
`4. 
`B.  Magnetic Stimulation for Rehabilitation, Healing, and Toning. ........ 27 
`C. 
`There Is No Technological Difference in Magnetic Stimulation
`for Rehabilitation, Healing, or Toning ................................................ 32 
`Conventional Features of Magnetic Stimulators and Treatment ........ 36 
`1. 
`Two Independently Positionable Applicators ........................... 36 
`2. 
`Belt to Attach Applicators to the Body ..................................... 39 
`3. 
`Capacitors as Energy Storage Devices for Coils ...................... 41 
`4. 
`Cooling Magnetic Field Generating Coils ................................ 42 
`5. 
`Generating Consecutive Impulses ............................................ 46 
`6. 
`Varying the Repetition Rate of a Time-Varying Magnetic
`Field........................................................................................... 47 
`
`D. 
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`E.
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`C.
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`V.
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`Trapezoidal Envelope ............................................................... 49
`7.
`Symmetrical Stimulation .......................................................... 51
`8.
`Simultaneous Applications of Magnetic Field and Radio-
`Frequency or Optical Wave in Treating Tissues ................................. 51
`THE ’576 PATENT ....................................................................................... 53
`A.
`Patent Overview .................................................................................. 53
`VI. CLAIM INTERPRETATION ....................................................................... 57
`VII. GROUND 1: THE CHALLENGED CLAIMS ARE RENDERED
`OBVIOUS BY SIMON ................................................................................. 58
`A.
`Overview of Simon ............................................................................. 58
`B.
`Independent Claims 1 and 16 .............................................................. 65
`1.
`Claim 1 ...................................................................................... 65
`2.
`Claim 16 .................................................................................... 89
`Dependent Claims 2-7 and 17-22 ......................................................103
`1.
`Claim 2 ....................................................................................103
`2.
`Claim 3 ....................................................................................104
`3.
`Claim 4 ....................................................................................106
`4.
`Claim 5 ....................................................................................107
`5.
`Claim 6 ....................................................................................108
`6.
`Claim 7 ....................................................................................109
`7.
`Claim 17 ..................................................................................109
`8.
`Claim 18 ..................................................................................110
`9.
`Claim 19 ..................................................................................111
`10. Claim 20 ..................................................................................111
`11. Claim 21 ..................................................................................111
`12. Claim 22 ..................................................................................112
`Claim Charts ......................................................................................113
`D.
`VIII. GROUND 2: THE CHALLENGED CLAIMS ARE RENDERED
`OBVIOUS BY BURNETT-’870 IN VIEW OF MAGSTIM ......................113
`A.
`Overview of Burnett-’870 .................................................................114
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`E. 
`
`B. 
`Overview of Magstim ........................................................................120 
`C.  Motivation to Modify Burnett-’870 in view of Magstim ..................126 
`D. 
`Independent Claims 1 and 16 ............................................................130 
`1. 
`Claim 1 ....................................................................................130 
`2. 
`Claim 16 ..................................................................................152 
`Dependent Claims 2-7 and 17-22 ......................................................166 
`1. 
`Claim 2 ....................................................................................166 
`2. 
`Claim 3 ....................................................................................166 
`3. 
`Claim 4 ....................................................................................168 
`4. 
`Claim 5 ....................................................................................169 
`5. 
`Claim 6 ....................................................................................169 
`6. 
`Claim 7 ....................................................................................170 
`7. 
`Claim 17 ..................................................................................171 
`8. 
`Claim 18 ..................................................................................172 
`9. 
`Claim 19 ..................................................................................172 
`10.  Claim 20 ..................................................................................173 
`11.  Claim 21 ..................................................................................173 
`12.  Claim 22 ..................................................................................174 
`Claim Charts ......................................................................................175 
`F. 
`IX.  GROUND 3: THE CHALLENGED CLAIMS 1-7, 16-22 ARE
`RENDERED OBVIOUS BY SIMON IN VIEW OF BURNETT-ʼ870 .....175 
`SECONDARY CONSIDERATIONS .........................................................181 
`X. 
`XI.  CONCLUSION ............................................................................................181 
`
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`I.
`
`INTRODUCTION
`A. Engagement
`1.
`I submit this report on behalf of Lumenis Be Ltd. in connection with
`
`its request for inter partes review of U.S. Patent No. 10,695,576 (the “’576
`
`patent”) to review and to provide my opinion on the scope and content of “prior
`
`art” predating the application for the ’576 patent and regarding the subject matter
`
`recited in the claims 1-7, 16-22 of the ’576 patent. I understand that this
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`Declaration relates to a Petition for the above-captioned inter partes review (IPR)
`
`of the ’576 patent.
`
`2.
`
`For my efforts in connection with the preparation of this declaration, I
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`have been compensated at my standard hourly consulting rate. My compensation
`
`is in no way contingent on the results of these or any other proceedings relating to
`
`the above-captioned patent. I have no expectation or promise of additional
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`business with the Petitioner in exchange for the positions explained herein.
`
`3.
`
`B.
`4.
`
`I make this declaration based on personal knowledge.
`
`Background and Qualifications
`A detailed description of my professional qualifications, including a
`
`listing of my specialties/expertise and professional activities, is contained in my
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`curriculum vitae, a copy of which is attached as Appendix A. In what follows, I
`
`provide a short summary of my professional qualifications.
`
`1
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`5.
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`I am a tenured Professor in the College of Engineering at The City
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`College, where I began as an Associate Professor in 2003. I serve as the
`
`University’s (Shames) Professor of Biomedical Engineering, a position I have held
`
`since 2014.
`
`6.
`
`I earned my Bachelor of Science in Biomedical Engineering, with a
`
`concentration in Electrical Engineering, from Johns Hopkins University in 1995. I
`
`earned my Ph.D. in Biomedical Engineering from Case Western Reserve
`
`University in 2000. The primary emphasis of my doctoral research pertained to the
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`mechanisms by which electrical stimulation effects the body including leading to
`
`excitation of tissue, how parameters of a stimulation device impact the effects of
`
`stimulation, and experience with a range of technology used to stimulate the body
`
`and quantify the effects of stimulation.
`
`7.
`
`In 2009, I founded Soterix Medical Inc. (“SMI”), for which I currently
`
`serve as a board member and technical advisor. Soterix Medical design, builds,
`
`distributes, and validates technology to stimulate the body as well as devices to
`
`measure the effects of that stimulation on the body. Soterix Medical technology is
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`used in hundreds of medical centers around the world.
`
`8.
`
`I serve on the leadership of numerous key scientific organizations in
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`the field of body stimulation. This includes as a member of the scientific program
`
`committee of the North American Neuromodulation Society, and the scientific
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`program committee of the International Brain Stimulation Conference. I am the
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`founding chairman of the NYC Neuromodulation meeting and have co-chaired
`
`each occurrence of this meeting.
`
`9.
`
`From 2003-2007, in addition to serving as the Harold Shames
`
`Assistant Professor of Biomedical Engineering at the City College of the City
`
`University of New York, I also served as an Assistant Professor for Programs in
`
`Engineering and Biology – Neuroscience at The Graduate School of the University
`
`Center of the City University of New York.
`
`10. From 2008-2014, in addition to serving as an Associate Professor of
`
`Biomedical Engineering at The City College of the City University of New York, I
`
`also served as an Associate Professor for Programs in Engineering and Biology –
`
`Neuroscience at The Graduate School of the University Center of the City
`
`University of New York.
`
`11. The claimed subject matter of the Challenged Patent pertains to a
`
`medical device for toning muscles by repeatedly inducing current in tissue to cause
`
`muscle contractions. This subject matter is within the scope of my education and
`
`professional experience.
`
`12.
`
`In regard to establishing what principles of magnetic stimulation
`
`device design impact resulting changes in the body, I have published an
`
`authoritative document (DOI: 10.1016/j.brs.2011.10.001). This document explains
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`3
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`how waveform parameters (pulse shape, frequency) and coil design govern the
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`resulting electrical current flow through the body and hence all physiological
`
`effects. I am a co-author and among the leaders on the technology section,
`
`specifically device design, of what is considered the definite guidance paper on
`
`transcranial magnetic stimulation (DOI: 10.1016/j.clinph.2020.10.003). I co-
`
`authored among the most studied and impactful papers on the design of electrical
`
`stimulation parameters (https://doi.org/10.1016/j.jneumeth.2004.10.020) which has
`
`been cited over 1906 times in scientific publications. I am the deputy editor
`
`responsible for technology at Brain Stimulation, among the most highly regarded
`
`journals in the field, where my responsibly includes oversight of the review of
`
`magnetic stimulation devices. I have lectured broadly on the principles of
`
`electromagnetic stimulation including providing the keynote or plenary lecture at
`
`major national and international meetings, as well as more focused lectures such as
`
`a lecture on the mechanisms of magnetic stimulation at the NYC Visiting
`
`Fellowship in Transcranial Magnetic Stimulation (2015).
`
`13.
`
`I have received numerous grants in the fields of electrical and
`
`biomedical engineering. I am currently in receipt of, or am involved in work
`
`associated with: a $1.7m grant from the National Institute of Health (“NIH”) for
`
`developing a new mechanism of brain stimulation via the coupled vascular
`
`hypothesis for transcranial direct current stimulation (“tDCS”); a $2.2m grant from
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`the NIH for developing automatic modeling software regarding tDCS; a $955K
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`grant from New York University and the City College of New York for advancing
`
`technology for home Neuromodulation in multiple sclerosis; a $1.7m grant from
`
`the NIH for evaluating the effects of tDCS on neuronal plasticity in brain slices;
`
`and a $250K grant from Boston Scientific for researching high frequency spinal
`
`cord stimulation.
`
`14.
`
`I am the previous recipient of at least an additional 52 other grants or
`
`awards, totaling millions of dollars in direct costs awarded.
`
`15.
`
`I have written and published widely in the fields of electrical and
`
`biomedical engineering. I have published, or currently have in press, at least 268
`
`articles with various academic journals across the world. I have written and
`
`published at least an additional 120 abstracts, in addition to being featured in at
`
`least 99 selected news and features in the press. My works have been cited over
`
`26,744 times in scientific publications. The topics of my publications include:
`
`
`
`Transcranial electrical and magnetic stimulation (tES and TMS) for
`
`addiction medicine: A consensus paper on the present state of the
`
`science and the road ahead. Neuroscience and Biobehavioral Reviews,
`
`104, 118-140 (2019);
`
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`
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`
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`
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`
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`
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`Higher-order power harmonics of pulsed electrical stimulation
`
`modulates corticospinal contribution of peripheral nerve stimulation.
`
`Scientific Reports, 7 (2017)
`
`Moreno-Duarte, I., Morse, L. R., Alam, M., Bikson, M., Zafonte, R.,
`
`& Fregni, F. Targeted therapies using electrical and magnetic neural
`
`stimulation for the treatment of chronic pain in spinal cord injury.
`
`NeuroImage, 85, 1003-1013 (2014);
`
`Comparing cortical plasticity induced by conventional and high-
`
`definition 4 × 1 ring tDCS: A neurophysiological study. Brain
`
`Stimulation, 6(4), 644-648 (2013) (doi:10.1016/j.brs.2012.09.010);
`
`Fundamentals of transcranial electric and magnetic stimulation dose:
`
`Definition, selection, and reporting practices. Brain Stimulation, 5(4),
`
`435-453 (2012); and
`
`Electrical stimulation of excitable tissue: Design of efficacious and
`
`safe protocols. Journal of Neuroscience Methods, 141(2), 171-198
`
`(2005).
`
`16.
`
`I am a named inventor on a U.S. patent regarding neurocranial
`
`electrostimulation models, systems, devices, and methods, in addition to two
`
`foreign patents. I am a named inventor on an additional nine U.S. patent
`
`applications and five international patent applications. Several of these patent
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`applications relate to neurocranial electrostimulation devices and other transcranial
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`stimulation systems and devices.
`
`C. Basis of My Opinion and Materials Considered
`17.
`I have reviewed the ’576 patent and the prior art and other documents
`
`and materials cited herein. For ease of reference, the full list of documents that I
`
`have considered is included in Appendix B.
`
`18. My opinions in this declaration are based on my review of these
`
`documents, as well as upon my education, training, research, knowledge, and
`
`experience.
`
`19.
`
`I have reviewed, had input into, and endorse as set forth fully herein
`
`the discussions in the accompanying Petition.
`
`D. Legal Standards for Patentability
`20.
`I am not an attorney and I offer no opinions on the law itself. My
`
`understanding of the relevant law principles this section is based on information
`
`provided to me by counsel.
`
`1. Obviousness
`I have been informed that a claim may be unpatentable under 35
`
`21.
`
`U.S.C. § 103(a) if the subject matter described by the claim as a whole would have
`
`been obvious in view of a prior art reference or in view of a combination of
`
`references at the time the alleged invention was made. I have been informed that
`
`obviousness is determined from the perspective of a hypothetical person of
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`ordinary skill in the art (“POSITA”) and that the challenged claims of the patent
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`should be read from the point of view of such a person at the time the alleged
`
`invention was made. I have been informed that a hypothetical person of ordinary
`
`skill in the art is assumed to know and to have all relevant prior art in the field of
`
`endeavor covered by the patent in suit, and would thus have been familiar with
`
`each of the references cited herein, as well as the background knowledge in the art,
`
`and the full range of teachings they contain.
`
`22.
`
`I have been informed that there are two criteria for determining
`
`whether prior art is analogous and thus can be considered prior art: (1) whether the
`
`art is from the same field of endeavor, regardless of the problem addressed, and (2)
`
`if the reference is not within the field of the patentee’s endeavor, whether the
`
`reference still is reasonably pertinent to the particular problem with which the
`
`patentee is involved. I have also been informed that the field of endeavor of a
`
`patent is not limited to the specific point of novelty, the narrowest possible
`
`conception of the field, or the particular focus within a given field. I have also
`
`been informed that a reference is reasonably pertinent if, even though it may be in
`
`a different field from that of the patentee’s endeavor, it is one which, because of
`
`the matter with which it deals, logically would have commended itself to a
`
`patentee’s attention in considering his problem.
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`23.
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`I have also been informed that an analysis of whether an alleged
`
`invention would have been obvious should be considered in light of the scope and
`
`content of the prior art, the differences (if any) between the prior art and the
`
`alleged invention, and the level of ordinary skill in the pertinent art involved. I
`
`have been informed as well that a prior art reference should be viewed as a whole.
`
`24.
`
`I have also been informed that in considering whether an invention for
`
`a claimed combination would have been obvious, I may assess whether there are
`
`apparent reasons to combine known elements in the prior art in the manner claimed
`
`in view of interrelated teachings of multiple prior art references, the effects of
`
`demands known to the design community or present in the market place, and/or the
`
`background knowledge possessed by a person having ordinary skill in the art. I
`
`have been informed that other principles may be relied on in evaluating whether an
`
`alleged invention would have been obvious, and that these principles include the
`
`following:
`
`
`
`
`
`A combination of familiar elements according to known methods is
`
`likely to be obvious when it does no more than yield predictable
`
`results;
`
`When a device or technology is available in one field of endeavor,
`
`design incentives and other market forces can prompt variations of it,
`
`either in the same field or in a different one, so that if a person of
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`ordinary skill can implement a predictable variation, the variation is
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`likely obvious;
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`
`
`If a technique has been used to improve one device, and a person of
`
`ordinary skill in the art would recognize that it would improve similar
`
`devices in the same way, using the technique is obvious unless its
`
`actual application is beyond his or her skill;
`
`
`
`An explicit or implicit teaching, suggestion, or motivation to combine
`
`two prior art references to form the claimed combination may
`
`demonstrate obviousness, but proof of obviousness does not depend
`
`on or require showing an explicit teaching, suggestion, or motivation
`
`to combine;
`
`
`
`
`
`
`
`Market demand, rather than scientific literature, can drive design
`
`trends and may show obviousness;
`
`In determining whether the subject matter of a patent claim would
`
`have been obvious, neither the particular motivation nor the avowed
`
`purpose of the named inventor controls;
`
`One of the ways in which a patent’s subject can be proved obvious is
`
`by noting that there existed at the time of invention a known problem
`
`for which there was an obvious solution encompassed by the patent’s
`
`claims;
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`
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`
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`
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`
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`Any need or problem known in the field of endeavor at the time of
`
`invention and addressed by the patent can provide a reason for
`
`combining the elements in the manner claimed;
`
`“Common sense” teaches that familiar items may have obvious uses
`
`beyond their primary purposes, and in many cases a person of
`
`ordinary skill will be able to fit the teachings of multiple patents
`
`together like pieces of a puzzle;
`
`A person of ordinary skill in the art is also a person of ordinary
`
`creativity, and is not an automaton;
`
`A patent claim can be proved obvious by showing that the claimed
`
`combination of elements was “obvious to try,” particularly when there
`
`is a design need or market pressure to solve a problem and there are a
`
`finite number of identified, predictable solutions such that a person of
`
`ordinary skill in the art would have had good reason to pursue the
`
`known options within his or her technical grasp; and
`
`
`
`One should be cautious of using hindsight in evaluating whether an
`
`alleged invention would have been obvious.
`
`25.
`
`I have further been informed that, in making a determination as to
`
`whether or not the alleged invention would have been obvious to a person of
`
`ordinary skill, the Board may consider certain objective factors if they are present,
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`such as: commercial success of products practicing the alleged invention; long-felt
`
`but unsolved need; teaching away; unexpected results; copying; and praise by
`
`others in the field. These factors are generally referred to as “secondary
`
`considerations” or “objective indicia” of nonobviousness. I have been informed,
`
`however, that for such objective evidence to be relevant to the obviousness of a
`
`claim, there must be a causal relationship (called a “nexus”) between the claim and
`
`the evidence and that this nexus must be based on what is claimed and novel in the
`
`claim rather than something in the prior art. I also have been informed that even
`
`when they are present, secondary considerations may be unable to overcome
`
`primary evidence of obviousness (e.g., motivation to combine with predictable
`
`results) that is sufficiently strong.
`
`26.
`
`I have been asked to consider the patentability of Claims 1-7, 16-22
`
`(the “Challenged Claims”) of the ’576 patent that are challenged in the Petition. I
`
`have been informed that for inter partes reviews, unpatentability must be shown
`
`under a preponderance of the evidence standard. I have been informed that to
`
`establish something by a preponderance of the evidence one needs to prove it is
`
`more likely true than not true. I have concluded that the Challenged Claims is
`
`unpatentable under 35 U.S.C. § 103 based on Simon, on Burnett-ʼ870 in view of
`
`Magstim, and on Simon in view of Burnett-ʼ870, as described below, under both
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`the preponderance of the evidence standard as well as the higher standard of clear
`
`and convincing evidence.
`
`2.
`Claim Construction
`I have been informed that patent claims are construed from the
`
`27.
`
`viewpoint of a person of ordinary skill in the art at the time of the alleged
`
`invention. I have been informed that patent claims generally should be interpreted
`
`consistent with their plain and ordinary meaning as understood by a person of
`
`ordinary skill in the art in the relevant time period (i.e., at the time of the purported
`
`invention, or the so called “effective filing date” of the patent application), after
`
`reviewing the patent claim language, the specification and the prosecution history
`
`(i.e., the intrinsic record).
`
`28.
`
`I have further been informed that a person of ordinary skill in the art
`
`must read the claim terms in the context of the claim itself, as well as in the context
`
`of the entire patent specification. I understand that in the specification and
`
`prosecution history, the patentee may specifically define a claim term in a way that
`
`differs from the plain and ordinary meaning. I understand that the prosecution
`
`history of the patent is a record of the proceedings before the U.S. Patent and
`
`Trademark Office, and may contain explicit representations or definitions made
`
`during prosecution that affect the scope of the patent claims. I understand that an
`
`applicant may, during the course of prosecuting the patent application, limit the
`
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`scope of the claims to overcome prior art or to overcome an examiner’s rejection,
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`by clearly and unambiguously arguing to overcome or distinguish a prior art
`
`reference, or to clearly and unambiguously disavow claim coverage.
`
`29.
`
`In interpreting the meaning of the claim language, I understand that a
`
`person of ordinary skill in the art may also consider “extrinsic” evidence, including
`
`expert testimony, inventor testimony, dictionaries, technical treatises, other patents,
`
`and scholarly publications. I understand this evidence is considered to ensure that
`
`a claim is construed in a way that is consistent with the understanding of those of
`
`skill in the art at the time of the alleged invention. This can be useful for technical
`
`terms whose meaning may differ from its ordinary English meaning. I understand
`
`that extrinsic evidence may not be relied on if it contradicts or varies the meaning
`
`of claim language provided by the intrinsic evidence, particularly if the applicant
`
`has explicitly defined a term in the intrinsic record.
`
`II. DESCRIPTION OF THE RELEVANT FIELD AND THE RELEVANT
`TIMEFRAME
`30.
`I have carefully reviewed the ’576 patent and its prosecution history.
`
`31.
`
`I understand, based on the Cross-Reference to Related Applications
`
`section of the ʼ576 patent (ʼ576, 1:5–50), that the ʼ576 patent issued from U.S.
`
`Patent Application 16/674,144, filed November 5, 2019, which is continuation of
`
`U.S. Patent Application, filed December 13, 2018, which is a continuation-in-part
`
`of each of: U.S. Patent Application 16/042,093, filed July 23, 2018; U.S. Patent
`
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`Application 16/034,093, filed July 13, 2018; U.S. Patent Application 16/034,793,
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`filed July 13, 2018; U.S. Patent Application 16/196,798, filed November 20, 2018;
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`and U.S. Patent Application 16/196,827, filed November 20, 2018.
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`32.
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`I understand that U.S. Patent Application 16/042,093 is a
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`continuation-in-part of U.S. Patent Application 15/344,811, filed November 7,
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`2016, and of U.S. Patent Application 15/954,783, filed April 17, 2018.
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`33.
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`I understand that U.S. Patent Application 15/954,783 is a
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`continuation-in-part of each of: U.S. Patent Application 15/862,410, filed
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`January 4, 2018; U.S. Patent Application 15/677,371 filed August 15, 2017; and
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`U.S. Patent Application 15/601,719, filed May 22, 2017.
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`34.
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`I understand that U.S. Patent Application 15/862,410 is a
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`continuation-in-part of U.S. Patent Application 15/473,390, filed March 29, 2017,
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`and of U.S. Patent Application 15/860,443, filed January 2, 2018
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`35.
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`I understand that U.S. Patent Application 15/677,371 is a
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`continuation-in-part of U.S. Patent Application 15/446,951, filed March 1, 2017,
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`and of U.S. Patent Application 15/404,384, filed January 12, 2017.
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`36.
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`I understand that U.S. Patent Application 15/446,951 is a
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`continuation-in-part of U.S. Patent Application 15/396,073, filed December 30,
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`2016; which is a continuation-in-part of U.S. Patent Application 15/178,455 filed
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`June 9, 2016; which is a continuation-in-part of U.S. Patent Application
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`15/151,012 filed May 10, 2016.
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`37.
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`I understand that the application claims the benefit of priority to the
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`following U.S. Provisional Applications: 62/441,805, filed January 3, 2017;
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`62/440,922, filed December 30, 2016; 62/440,940, filed December 30, 2016;
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`62/440,936, filed December 30, 2016; 62/440,912, filed December 30, 2016;
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`62/440,905, filed December 30, 2016; 62/357,679, filed July 1, 2016.
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`38.
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`In the Application Data Sheet, Applicant indicates that the ʼ576 patent
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`claims priority to U.S. Application 14/926,365, filed on July 1, 2015. Ex-1003,
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`188. It appears that this application is the earliest application to which the ʼ576
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`patent may claim priority.
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`39. Accordingly, I have been instructed by counsel to assume the relevant
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`timeframe for my analysis in this declaration to be on or before July 1, 2015.1
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`40. Based on my review of this material, I believe that the relevant
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`general field for the purpose of the ’576 patent is electromagnetic stimulation of
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`the body.
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`1 I have not been asked to consider whether this date is the correct priority date.
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`III. THE PERSON OF ORDINARY SKILL IN THE RELEVANT FIELD
`IN THE RELEVANT TIMEFRAME
`41. My opinions are provided based on what a person of ordinary skill in
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`the art in the technical field of the invention would have understood at the time of
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`the invention of the Challenged Claims. As I explained above, the relevant
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`timeframe in this Declaration is on or before July 1, 2015. I have been informed
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`and understand that the content of a patent and prior art should be interpreted the
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`way a person of ordinary skill in the art (“person of ordinary skill”) would have
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`interpreted those references at the time of the invention of the patent using the
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`ordinary and customary meanings of the claim terms. I understand that the factors
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`considered in determining the ordinary level of skill in a field of art include the
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`level of education and experience of persons working in the field; the types of
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`problems encountered in the field; the teachings of the prior art; and the
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`sophistication of the technology at the time of the alleged invention. I understand
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`that a person of ordinary skill in the art is not a specific real individual, but rather
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`is a hypothetical individual having the qualities reflected by the factors above. I
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`understand that a person of ordinary skill in the art would also have knowledge
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`from the teachings of the prior art, including the art cited below.
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`42. Taking these factors into account, it is my opinion that, on or before
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`July 1, 2015, a person of ordinary skill in the field of the Challenged Claims would
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`have been someone with a good working knowledge of devices that apply
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`electromagnetic energy to stimulate biological tissue (e.g., brains, spinal cords,
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`nerves, or muscles). A person of ordinary skill to whom the patent is addressed
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`would have a bachelor’s degree in biomedical engineeri