UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`LUMENIS LTD.,
`Petitioner,
`
`v.
`
`
`
`
`BTL HEALTHCARE TECHNOLOGIES A.S.,
`Patent Owner
`
`____________
`
`Case IPR2021-01275
`
`U.S. Patent No. 10,632,321
`
`____________
`
`DECLARATION OF DR. MAROM BIKSON
`
`
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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 ........................................................... 15 
`IV.  TECHNICAL BACKGROUND AND STATE OF THE ART .................... 17 
`A.  Developments In Magnetic Muscle-Stimulation Technology ............ 17 
`1. 
`Problems Discussed In The ʼ321 Patent ................................... 17 
`2. 
`Stimulation Occurs By Inducing Current in Biological
`Tissue ........................................................................................ 18 
`Stimulation Parameters ............................................................. 20 
`3. 
`Components Of A Magnetic Stimulation Device ..................... 24 
`4. 
`B.  Magnetic Stimulation for Rehabilitation, Healing, and Toning. ........ 26 
`C. 
`There Is No Technological Difference In Magnetic Stimulation
`For Rehabilitation, Healing, or Toning ............................................... 30 
`Conventional Features of Magnetic Stimulators and Treatment ........ 34 
`1. 
`Two Independently Positionable Applicators ........................... 34 
`2. 
`Belt To Attach Applicators to the Body ................................... 37 
`3. 
`Capacitors as Energy Storage Devices for Coils ...................... 39 
`4. 
`Cooling Magnetic Field Generating Coils ................................ 40 
`5. 
`Generating Consecutive Impulses ............................................ 44 
`6. 
`Varying the Repetition Rate of a Time-Varying Magnetic
`Field........................................................................................... 45 
`
`D. 
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`V. 
`
`C. 
`
`2. 
`
`7. 
`Trapezoidal Envelope ............................................................... 47 
`Symmetrical Stimulation .......................................................... 48 
`8. 
`THE ’321 PATENT ....................................................................................... 49 
`A. 
`Patent Overview .................................................................................. 49 
`B. 
`Prosecution History ............................................................................. 53 
`VI.  CLAIM INTERPRETATION ....................................................................... 54 
`VII.  GROUND 1: THE CHALLENGED CLAIMS ARE RENDERED
`OBVIOUS BY SIMON ................................................................................. 54 
`A.  Overview of Simon ............................................................................. 54 
`B. 
`Independent Claims 1 and 8 ................................................................ 61 
`1. 
`Claim 1 ...................................................................................... 61 
`2. 
`Claim 8 ...................................................................................... 84 
`Dependent Claims 2-7 and 9-14 ........................................................100 
`1. 
`Claim 2: The method of claim 1, further comprising:
`independently positioning the first applicator on the body
`region with respect to the second applicator. ..........................100 
`Claim 3: The method of claim 2, further comprising:
`coupling the first and second applicators to the patient
`such that the first applicator is coupled to a first area of
`the body region and the second applicator is coupled to a
`second area of the body region, wherein the first body
`region area is different from the second area. .........................100 
`Claim 4: The method of claim 2, further comprising: ............101 
`Claim 5: The method of claim 1, further comprising:
`directing the oil into the first applicator and into the
`second applicator. ....................................................................102 
`Claim 6: The method of claim 1, wherein the first
`magnetic field generating coil has a first inductance,
`wherein the second magnetic field generating coil has a
`second inductance, wherein the first inductance and the
`second inductance are equal, and wherein the first time-
`varying magnetic field and the second time-varying
`
`3. 
`4. 
`
`5. 
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`6. 
`
`magnetic field are generated with an impulse duration in
`a range of 3 μs to 3 ms. ...........................................................103 
`Claim 7: The method of claim 6, wherein the first muscle
`and the second muscle are cooperating muscles. ....................105 
`Claim 9: The method of claim 8, ............................................106 
`7. 
`Claim 10: The method of claim 8, further comprising: ..........107 
`8. 
`Claim 11: The method of claim 10 .........................................110 
`9. 
`10.  Claim 12: The method of claim 8, further comprising:
`directing a fluid cooling media into the first applicator
`and into the second applicator such that the first magnetic
`field generating coil and the second magnetic field
`generating coil are cooled by the fluid cooling media. ...........112 
`11.  Claim 13: The method of claim 12, wherein the first
`magnetic field generating coil and the second magnetic
`field generating coil have the same inductance. .....................113 
`12.  Claim 14: The method of claim 13, further comprising:
`initiating a treatment protocol using a touchscreen
`graphical user interface, wherein the treatment protocol
`comprises a set of predetermined treatment sequences
`having predetermined repetition rates configured to be
`applied for a predetermined time period. ................................113 
`Claim Charts ......................................................................................115 
`D. 
`VIII.  GROUND 2: THE CHALLENGED CLAIMS ARE RENDERED
`OBVIOUS BY BURNETT-’870 IN VIEW OF MAGSTIM ......................115 
`A.  Overview of Burnett-’870 .................................................................116 
`B. 
`Overview of Magstim ........................................................................122 
`C.  Motivation to Modify Burnett-’870 in view of Magstim ..................127 
`D. 
`Independent Claims 1 and 8 ..............................................................131 
`1. 
`Claim 1 ....................................................................................131 
`2. 
`Claim 8 ....................................................................................157 
`Dependent Claims 2-7 and 9-14 ........................................................176 
`1. 
`Claim 2: The method of claim 1, further comprising:
`independently positioning the first applicator on the body
`region with respect to the second applicator. ..........................176 
`
`E. 
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`2. 
`
`5. 
`
`6. 
`
`3. 
`4. 
`
`Claim 3: The method of claim 2, further comprising:
`coupling the first and second applicators to the patient
`such that the first applicator is coupled to a first area of
`the body region and the second applicator is coupled to a
`second area of the body region, wherein the first body
`region area is different from the second area. .........................176 
`Claim 4: The method of claim 2, further comprising: ............177 
`Claim 5: The method of claim 1, further comprising:
`directing the oil into the first applicator and into the
`second applicator. ....................................................................178 
`Claim 6: The method of claim 1, wherein the first
`magnetic field generating coil has a first inductance,
`wherein the second magnetic field generating coil has a
`second inductance, wherein the first inductance and the
`second inductance are equal, and wherein the first time-
`varying magnetic field and the second time-varying
`magnetic field are generated with an impulse duration in
`a range of 3 μs to 3 ms. ...........................................................179 
`Claim 7: The method of claim 6, wherein the first muscle
`and the second muscle are cooperating muscles. ....................180 
`Claim 9: The method of claim 8, ............................................181 
`7. 
`Claim 10: The method of claim 8, further comprising: ..........182 
`8. 
`Claim 11: The method of claim 10 .........................................184 
`9. 
`10.  Claim 12: The method of claim 8, further comprising:
`directing a fluid cooling media into the first applicator
`and into the second applicator such that the first magnetic
`field generating coil and the second magnetic field
`generating coil are cooled by the fluid cooling media. ...........188 
`11.  Claim 13: The method of claim 12, wherein the first
`magnetic field generating coil and the second magnetic
`field generating coil have the same inductance. .....................188 
`12.  Claim 14: The method of claim 13, further comprising:
`initiating a treatment protocol using a touchscreen
`graphical user interface, wherein the treatment protocol
`comprises a set of predetermined treatment sequences
`having predetermined repetition rates configured to be
`applied for a predetermined time period. ................................188 
`
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`F. 
`Claim Charts ......................................................................................190 
`IX.  GROUND 3: THE CHALLENGED CLAIMS 8-14 ARE
`RENDERED OBVIOUS BY SIMON IN VIEW OF BURNETT-ʼ870 .....190 
`SECONDARY CONSIDERATIONS .........................................................196 
`X. 
`XI.  CONCLUSION ............................................................................................197 
`
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`I.
`
`INTRODUCTION
`A. Engagement
`1.
`I submit this report on behalf of Lumenis Ltd. in connection with its
`
`request for inter partes review of U.S. Patent No. 10,632,321 (the “’321 patent”) to
`
`review and to provide my opinion on the scope and content of “prior art” predating
`
`the application for the ’321 patent and regarding the subject matter recited in the
`
`claims 1-14 of the ’321 patent. I understand that this Declaration relates to a
`
`Petition for the above-captioned inter partes review (IPR) of the ’321 patent.
`
`2.
`
`For my efforts in connection with the preparation of this declaration, I
`
`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
`
`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
`
`curriculum vitae, a copy of which is attached as Appendix A. In what follows, I
`
`provide a short summary of my professional qualifications.
`
`5.
`
`I am a tenured Professor in the College of Engineering at The City
`
`College, where I began as an Associate Professor in 2003. I serve as the
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`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
`
`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
`
`used in hundreds of medical centers around the world.
`
`8.
`
`I serve on the leadership of numerous key scientific organizations in
`
`the field of body stimulation. This includes as a member of the scientific program
`
`committee of the North American Neuromodulation Society, and the scientific
`
`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
`
`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
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`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 1736 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
`
`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
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`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
`
`25,595 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);
`
`
`
`Higher-order power harmonics of pulsed electrical stimulation
`
`modulates corticospinal contribution of peripheral nerve stimulation.
`
`Scientific Reports, 7 (2017)
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`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
`
`applications relate to neurocranial electrostimulation devices and other transcranial
`
`stimulation systems and devices.
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`C. Basis of My Opinion and Materials Considered
`17.
`I have reviewed the ’321 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
`
`ordinary skill in the art (“POSITA”) and that the challenged claims of the patent
`
`should be read from the point of view of such a person at the time the alleged
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`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.
`
`23.
`
`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
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`alleged invention, and the level of ordinary skill in the pertinent art involved. I
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`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
`
`ordinary skill can implement a predictable variation, the variation is
`
`likely obvious;
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`
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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 1-14 (the
`
`“Challenged Claims”) of the ’321 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 are 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 the
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`preponderance of the evidence standard as well as the higher standard of clear and
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`convincing evidence.
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`2.
`Claim Construction
`I have been informed that patent claims are construed from the
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`27.
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`viewpoint of a person of ordinary skill in the art at the time of the alleged
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`invention. I have been informed that patent claims generally should be interpreted
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`consistent with their plain and ordinary meaning as understood by a person of
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`ordinary skill in the art in the relevant time period (i.e., at the time of the purported
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`invention, or the so called “effective filing date” of the patent application), after
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`reviewing the patent claim language, the specification and the prosecution history
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`(i.e., the intrinsic record).
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`28.
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`I have further been informed that a person of ordinary skill in the art
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`must read the claim terms in the context of the claim itself, as well as in the context
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`of the entire patent specification. I understand that in the specification and
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`prosecution history, the patentee may specifically define a claim term in a way that
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`differs from the plain and ordinary meaning. I understand that the prosecution
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`history of the patent is a record of the proceedings before the U.S. Patent and
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`Trademark Office, and may contain explicit representations or definitions made
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`during prosecution that affect the scope of the patent claims. I understand that an
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`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
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`reference, or to clearly and unambiguously disavow claim coverage.
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`29.
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`In interpreting the meaning of the claim language, I understand that a
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`person of ordinary skill in the art may also consider “extrinsic” evidence, including
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`expert testimony, inventor testimony, dictionaries, technical treatises, other patents,
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`and scholarly publications. I understand this evidence is considered to ensure that
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`a claim is construed in a way that is consistent with the understanding of those of
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`skill in the art at the time of the alleged invention. This can be useful for technical
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`terms whose meaning may differ from its ordinary English meaning. I understand
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`that extrinsic evidence may not be relied on if it contradicts or varies the meaning
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`of claim language provided by the intrinsic evidence, particularly if the applicant
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`has explicitly defined a term in the intrinsic record.
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`II. DESCRIPTION OF THE RELEVANT FIELD AND THE RELEVANT
`TIMEFRAME
`30.
`I have carefully reviewed the ’321 patent and its prosecution history.
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`31.
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`I understand that the ’321 patent issued from U.S. Patent Application
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`16/673,683, filed on November 4, 2019, and is a continuation of application No.
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`16/266,494, filed on February 4, 2019, which is a continuation-in-part of
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`application No. 15/601,719, filed on May 22, 2017. The ʼ321 patent further claims
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`priority to provisional application No. 62/786,731, filed on December 31, 2018,
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`provisional application No. 62/357,679, filed on July 1, 2016, provisional
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`application No. 62/440,905, filed on December 30, 2016, and provisional
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`application No. 62/440,922, filed on December 30, 2016.
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`32.
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`I have been instructed by counsel to assume the relevant timeframe
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`for my analysis in this declaration to be on or before July 1, 2016.1
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`33. Based on my review of this material, I believe that the relevant
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`general field for the purpose of the ’321 patent is electromagnetic stimulation of
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`the body.
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`III. THE PERSON OF ORDINARY SKILL IN THE RELEVANT FIELD
`IN THE RELEVANT TIMEFRAME
`34. 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, 2016. 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
`
`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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`1 I have not been asked to consider whether this date is the correct priority date.
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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 spec