UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`PEAKLOGIC, INC.,
`Petitioner
`
`v.
`
`WAVE NEUROSCIENCE, INC.,
`Patent Owner
`___________________
`
`Case No. TBD
`Patent No. 8,475,354
`___________________
`
`DECLARATION OF ROBERT SILVETZ, M.D.
`
`PeakLogic, Inc. Ex. 1003
`PeakLogic, Inc. v. Wave Neuroscience, Inc., Case No. TBD
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`

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`
`I, Robert D. Silvetz, M.D., declare as follows:
`I have personal knowledge of the following facts and, if called upon to do
`1.
`so, I could and would testify competently thereto.
`I have a Bachelor of Arts degree in Computer Science, a Bachelor of Arts
`2.
`degree in Medical Sciences, and a Doctor of Medicine degree from the Boston University
`School of Medicine.
`I have worked in healthcare since 1989. I am currently employed by Clinical
`3.
`Guns for Hire (CGH), a sole proprietorship consulting business in the field of device,
`medical, service, and transcranial magnetic stimulation (TMS) consulting to physicians. I
`have over ten years of experience in the field of individualized Electroencephalogram
`(EEG)-guided TMS therapy for autism, stroke, post-traumatic stress disorder (PTSD),
`depression, anxiety, stroke-induced dementia, and cognitive decline from chemotherapy.
`My curriculum vitae is attached as Attachment A.
`I am an inventor named on U.S. Patent number 8,697,104, titled “Apparatus,
`4.
`system, and method for creating immunologically enhanced spaces in-vivo;” and on U.S.
`Patent number 10,350,427, titled “rTMS device.” I do not have any pecuniary interest in
`Patent number 10,350,427.
`In the past ten years, I have authored or co-authored the following
`5.
`publications: Taghva, et al., Magnetic Resonance Therapy Improves Clinical Phenotype
`and EEG Alpha Power in Posttraumatic Stress Disorder, Trauma Mon., Nov. 2015
`(published online Nov. 23, 2015; PMID: 26839865; PMCID: PMC4727473; available at
`https://pubmed.ncbi.nlm.nih.gov/26839865/).
`I have not testified as an expert at trial or by deposition in any cases within
`6.
`the past five years.
`I have been retained by PeakLogic, Inc., the Petitioner in this matter, to
`7.
`testify and provide my professional opinion regarding the public disclosures and claimed
`subject matter of U.S. Patent numbers 8,475,354 (“the ’354 Patent”), 8,480,554 (“the
`’554 Patent”), and 9,446,259 (“the ’259 Patent”) (collectively, “the challenged patents”).
`
`PeakLogic, Inc. Ex. 1003
`PeakLogic, Inc. v. Wave Neuroscience, Inc., Case No. TBD
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`In particular, I have been asked to give my opinion about: a) the level of ordinary skill in
`the technological art that is the subject matter of the challenged patents at the time of the
`invention; b) how a person of ordinary skill in the art at the time of the invention would
`interpret the terms recited in the claims of the asserted patents, in view of the written
`descriptions provided in the patents, the prosecution history of the patents, and relevant
`prior art; c) the teachings of certain prior art publications; d) whether certain prior art
`publications disclose the elements recited in the claims of the challenged patents; and e)
`whether a person of ordinary skill in the art at the time of the invention would consider
`the combinations of elements recited in the claims of the challenged patents to be obvious
`in view of certain prior art publications.
`In forming my opinions, I reviewed the challenged patents, their prosecution
`8.
`histories, and the prior art references discussed in this declaration. All of those documents
`are publicly available. I also applied my generalized medical knowledge from my
`medical training and work experience, where appropriate. In forming my opinions, I have
`not viewed, relied on, or disclosed any confidential or trade secret information belonging
`to any party, other person, or business entity. To be clear, from March 2012 to August
`2015, I worked as the Chief Science Officer and Physician Liaison at Newport Brain
`Research Laboratory (NBRL), and it is my understanding that the Patent Owner in this
`case (Wave Neuroscience, Inc. (“Wave”)) is a successor business entity of NBRL. In
`forming my opinions, however, I have not viewed, relied on, or disclosed any
`confidential or trade secret information that belonged to NBRL or belongs to Wave.
`Moreover, it is my understanding that Wave acquired the challenged patents from
`NeoSync, Inc. (not NBRL) in 2020, five years after I left NBRL. It is my understanding
`that patents and their prosecution histories are public documents and that nothing
`disclosed in them can be considered confidential or a trade secret.
`9. When interpreting the scope of the claims of the challenged patents, I have
`construed the claims in accordance with the ordinary and customary meaning of each
`claim as understood by one of ordinary skill in the art at the time of the invention, in view
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`PeakLogic, Inc. Ex. 1003
`PeakLogic, Inc. v. Wave Neuroscience, Inc., Case No. TBD
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`of the written description and the prosecution history pertaining to the patent.
`10. Upon reading the face of the ’354 and ’554 Patents, it is my understanding
`that they claim priority to provisional patent applications that were filed on September
`25, 2007, and September 12, 2008. Upon reading the face of the ’259 Patent, it is my
`understanding that it claims earliest priority to a provisional patent application that was
`filed on November 12, 2009. For purposes of my opinions regarding the level of skill and
`knowledge of a person of ordinary skill in the art at the time of the invention, I therefore
`consider the time immediately before September 25, 2007, to be the relevant timeframe
`when I refer to “the time of the invention” with respect to all three patents. I chose this
`timeframe strictly for purposes of my analysis, and I do not have nor do I intend to
`express any opinion as to when the patentees purportedly invented the material recited in
`the claims, if they did so at all. Nor by referring to “the time of the invention” do I
`necessarily agree that the patents claim any “invention” that was novel or not obvious to
`a person of ordinary skill in the art at the time.
`11. Furthermore, in my descriptions and discussions of the natural responses and
`properties of the typical human brain, I am not limiting those descriptions and discussions
`to what was known at the time of the invention. The natural, biological properties of the
`typical human brain have not changed since 2007. They are inherent properties of the
`brain, regardless of whether they were known at the time of the invention.
`It is my opinion that a person of ordinary skill in the art pertaining the
`12.
`patents at the time of the invention would have a medical degree plus at least two years of
`academic and/or industry experience in the field of TMS. Additional professional and/or
`technical experience could substitute for education, and vice versa.
`13. Of the prior art references I considered, in particular, I reviewed Klimesch et
`al., Enhancing Cognitive Performance with Repetitive Transcranial Magnetic Stimulation
`at Human Individual Alpha Frequency, 17 European Journal of Neuroscience 1129-33
`(2003) (“Klimesch”) and Yi Jin et al., Therapeutic Effects of Individualized Alpha
`Frequency Transcranial Magnetic Stimulation on the Negative Symptoms of
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`PeakLogic, Inc. Ex. 1003
`PeakLogic, Inc. v. Wave Neuroscience, Inc., Case No. TBD
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`Schizophrenia, 32 Schizophrenia Bulletin 557 (October 27, 2005) (“Jin”).
`14. As early as 1991, numerous studies have shown that applying Repetitive
`Transcranial Magnetic Stimulation (rTMS) at frequencies in and around the alpha band of
`the human brain can shift, augment, and tune the intrinsic frequency of a subject’s brain
`waves to enhance cognitive performance and treat mental disorders. In particular,
`Klimesch cites Pascual-Leone et al. (1994), Grafman et al. (1994), Chen et al. (1997),
`Hamilton & Pascual-Leone (1998), Wasserman et al. (1999), Mottagy et al. (1999),
`Triggs et al. (1999), Evers et al. (2001), Sparing et al. (2001), Boroojerdi et al. (2001),
`and Triggs & Kirshner (2001) as relevant studies in the field.
`15. The alpha band is the bandwidth of brain wave frequencies between about 8
`and 13 Hz. Activity at these brain wave frequencies and at other brain wave frequencies
`outside the alpha band are readable by Electroencephalogram (EEG). Computer-
`processed output of an EEG can produce a frequency-domain depiction of a subject’s
`brain wave activity across a spectrum of frequencies in various regions of the brain.
`16. EEG technology and EEG machines were well-known in the medical field at
`the time of the invention. EEG machines were available from multiple different vendors
`at the time of the invention. EEGs were especially well-known in the field of rTMS,
`because they were integral to rTMS treatments, research, and clinical trials. Standard
`practice often included taking an EEG reading of the patient’s brain before administering
`rTMS or before deciding on an rTMS course of treatment, then taking another EEG
`reading after treatment to observe the effect, if any, of the rTMS on the patient’s brain
`wave activity.
`rTMS technology and rTMS machines were well-known in the medical field
`17.
`at the time of the invention, especially in the field of treating brain disorders such as
`schizophrenia, depression, and anxiety. As noted by both Klimesch and Jin, rTMS and
`the brain’s natural response to rTMS were also areas of research and scholarship at that
`time.
`
`18.
`
`rTMS machines were available from multiple different vendors at the time
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`PeakLogic, Inc. Ex. 1003
`PeakLogic, Inc. v. Wave Neuroscience, Inc., Case No. TBD
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`of the invention. One example of such a machine was the MagStim Rapid stimulator,
`which was commercially available at the time of the invention. The MagStim Rapid
`stimulator, like other rTMS machines, could be programmed, using a computer, to
`control the output of an electromagnet placed close to the head of a subject to apply the
`rTMS treatment. The MagStim Rapid, like other rTMS machines, could control the
`electromagnet to apply repetitive transcranial magnetic fields to the subject’s brain at any
`one of a number of different frequencies, including frequencies in the alpha band. Those
`frequencies could include the subject’s intrinsic alpha frequency, determined by EEG, but
`could also include other frequencies in the alpha band and frequencies outside the alpha
`band. These machines predate the priority dates of the challenged patents.
`19. Magnetic technology in the form of both electromagnetic and permanent
`magnetic technology for the generation of magnetic fields was well known at the time of
`the invention. especially electromagnetics in fields utilizing rTMS. Many different
`electromagnets for use in rTMS therapy were available from multiple different vendors at
`the time of the invention. Permanent magnets having a strength within the range of 10
`Gauss and about 1 Tesla were well known at the time of the invention.
`20. The human brain naturally responds to rTMS. The brain’s natural response
`varies depending on factors such as: a) the location of the electromagnet; b) the frequency
`of stimulation; c) the duration of stimulation; d) the number of stimulation pulses
`administered; e) the amplitude of the pulses administered; and f) the patient’s physiology.
`In particular, at the time of the priority date of the patents, it was known that applying a
`course of rTMS treatment at or near an individual subject’s peak frequency in the alpha
`band (called the “intrinsic frequency” or the “intrinsic alpha frequency”) triggered a
`marked increase in the power of that subject’s peak frequency in the alpha band, as
`observed using EEG. Both Jin and Klimesch observed and documented this effect in their
`studies. Specifically, Jin applied courses of rTMS treatment at the nearest integer
`frequency to the subjects’ peak frequency in the alpha band, and Klimesch applied
`courses of rTMS treatment at the subject’s peak frequency in the alpha band plus one Hz,
`
`PeakLogic, Inc. Ex. 1003
`PeakLogic, Inc. v. Wave Neuroscience, Inc., Case No. TBD
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`and they both observed and documented the resulting increase in power in the patients’
`alpha band. Jin and Klimesch (and others) also studied the effects of rTMS at other
`frequencies outside the alpha band, such as at 5 Hz and 20 Hz, and although the brain
`naturally responds to stimulation at those frequencies as well, the response at those
`frequencies is different from the response to stimulation at or near the patient’s peak
`alpha frequency.
`21. As the power of a subject’s peak alpha frequency increases in response to
`rTMS at or near the subject’s peak alpha frequency, this naturally alters the shape of the
`patient’s brain wave frequency spectrum, as observed using EEG. First, the peak alpha
`frequency itself changes. In response to stimulation at a frequency in the alpha band that
`is higher than the patient’s peak alpha frequency, the peak alpha frequency increases in
`the alpha band – meaning, the peak alpha frequency moves from one frequency to a
`higher frequency. In response to stimulation at a frequency in the alpha band that is lower
`than the patient’s peak alpha frequency, the peak alpha frequency decreases in the alpha
`band – meaning, the peak alpha frequency moves from one frequency to a lower
`frequency. These are natural responses of the typical human brain to such stimulation.
`22. Second, the amplitude of the peak alpha frequency also changes. In response
`to stimulation at or near the subject’s peak alpha frequency, the amplitude of the subject’s
`peak alpha frequency increases. This is also a natural response of the typical human brain
`to such stimulation.
`23. Third, the quality, tightness, or “Q-factor” of the peak alpha frequency also
`changes. In response to stimulation at or near the subject’s peak alpha frequency, as the
`amplitude of the subject’s peak alpha frequency increases, the peak takes on a sharper,
`tighter, more defined shape in the frequency spectrum observed using EEG, where the
`ratio corresponding to the peak’s amplitude divided by the peak’s bandwidth increases.
`This effect also often accompanies a reduction in the “noise” attributable to brain waves
`at frequencies other than the peak alpha frequency. This reduction in noise is part of the
`natural response of the human brain to rTMS at or near the subject’s peak alpha
`
`PeakLogic, Inc. Ex. 1003
`PeakLogic, Inc. v. Wave Neuroscience, Inc., Case No. TBD
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`frequency. As the power of the noise decreases and the power of the peak alpha
`frequency increases, the peak naturally takes on a tighter, more defined shape in the
`frequency spectrum observed using EEG. A known measurement of the peak’s tightness
`is the quality factor, or “Q-factor,” which the patents define as f0/Δf, where Δf is the
`frequency bandwidth for which the energy of the peak is above one-half the peak energy.
`This increase in Q-factor in response to rTMS at or near the subject’s peak alpha
`frequency is a natural response of the typical human brain to such stimulation.
`24. The challenged claims of the ’554 Patent recite an “EEG phase.” That term
`is nonsensical on its face and would have no plain and ordinary meaning to a person of
`ordinary skill in the art at the time of the invention. A brain wave in the human brain may
`be described as a time domain signal having a phase. An EEG is merely a tool for
`measuring many brain waves at many different frequencies and converting that
`information into a frequency domain spectrum for analysis. To say that a human brain
`has an “EEG phase” would have no meaning to a person of ordinary skill in the art at the
`time of the invention, and the written descriptions and prosecution histories of the patents
`do not provide any express definition to clarify the meaning of that term.
`25. On page 1132 of the Klimesch paper, Klimesch observed that “[t]he
`influence of rTMS at IAF on EEG parameters mimicked exactly that situation which we
`know is typical for good performance: increased reference power, decreased test power
`and, consequently, a large ERD.” With respect to “[t]he influence of rTMS on EEG
`parameters,” this is referring to the previous observation in Klimesch that “[c]ompared
`with sham, rTMS at IAF + 1 Hz, induced a significant increase in lower-2 and upper
`alpha desynchronization (ERD) during mental rotation…. For the upper alpha band factor
`stimulation condition (F2,10 = 8.82, P < 0.05) reached significance.” With respect to “the
`situation which we know is typical for good performance,” this is referring to prior
`studies in the field of rTMS, many of which are cited on page 1129, that correlated the
`extent of ERD with improved cognitive performance. Klimesch thus observed that
`stimulation at IAF + 1 Hz induced a significant increase in upper alpha ERD
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`PeakLogic, Inc. Ex. 1003
`PeakLogic, Inc. v. Wave Neuroscience, Inc., Case No. TBD
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`corresponding to the expected increased energy of the peak in the upper alpha band
`(between IAF and IAF + 2 Hz). That increased energy would appear on an EEG of the
`upper alpha band as the expected change in the amplitude of the peak alpha frequency,
`and the corresponding change in shape of that peak would cause a change in the Q-factor
`of that peak, since the shape of the peak and its Q-factor are, by definition, related. In
`other words, the before-treatment Q-factor of the subjects’ peak frequency in the alpha
`band moved to a different, sharper after-treatment Q-factor of the subjects’ peak
`frequency in that same band. In sum, by applying rTMS to subjects’ brains at each
`subject’s IAF + 1 Hz, Klimesch triggered and observed the human brain’s natural,
`inherent response to stimulation at or near the subject’s peak alpha frequency.
`26. Similar to Klimesch, Jin applied rTMS at the frequency that was the nearest
`integer value to subjects’ individual peak alpha frequency, determined by EEG, and
`observed that “[t]he individualized αTMS produced a marked increase (34% +/- 0.3) in
`power of the alpha EEG activity,” with corresponding improvements in negative
`symptoms. Like Klimesch, Jin thus triggered and observed the human brain’s natural,
`inherent response to stimulation at or near the subject’s peak alpha frequency. As I
`discussed above, that natural, inherent response included changes in the characteristics of
`the individual subject’s peak frequency in the alpha band, with a corresponding change in
`the Q-factor of that peak. In other words, the before-treatment Q-factor of the subject’s
`peak frequency in the alpha band moved to a different, sharper after-treatment Q-factor of
`the subjects’ peak frequency in that same band.
`
`PeakLogic, Inc. Ex. 1003
`PeakLogic, Inc. v. Wave Neuroscience, Inc., Case No. TBD
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`

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`I declare under penalty of perjury that the foregoing is true and correct. Executed
`on September 9, 2022, at the Bronx, New York.
`
`September 9,2022
`frot
`
`10
`
`PeakLogic, Inc. Ex. 1003
`PeakLogic, Inc. v. Wave Neuroscience, Inc., Case No. TBD
`
`