UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________________
`
`MOLECULIGHT, INC.
`Petitioner
`
`v.
`SWIFT MEDICAL INC.
`Patent Owner
`
`_________________________________
`
`PGR2022-XXXXXX
`U.S. Patent 11,266,345
`_________________________________
`
`
`DECLARATION OF IRENE GEORGAKOUDI, PH.D. IN SUPPORT
`OF PETITION FOR POST GRANT REVIEW
`
`Petitioner's Exhibit 1004
`Page 1 of 128
`
`
`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________________
`
`MOLECULIGHT, INC.
`Petitioner
`
`v.
`SWIFT MEDICAL INC.
`Patent Owner
`
`_________________________________
`
`PGR2022-XXXXXX
`U.S. Patent 11,266,345
`_________________________________
`
`
`DECLARATION OF IRENE GEORGAKOUDI, PH.D. IN SUPPORT
`OF PETITION FOR POST GRANT REVIEW
`
`Petitioner's Exhibit 1004
`Page 1 of 128
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`
`
`Exhibit
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`PETITIONER’S EXHIBIT LIST
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`Description of Exhibit
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`1001
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`U.S. Patent No. 11,266,345
`
`1002
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`Prosecution History of U.S. Patent No. 11,266,345
`
`1003
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`U.S. Provisional Application No. 62/698,799
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`1004
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`Declaration of Irene Georgakoudi, Ph.D. in support of Petition for
`Post Grant Review (“Expert”)
`
`1005
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`Curriculum Vitae of Irene Georgakoudi, Ph.D.
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`1006
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`U.S. Patent Application Publication US 2019/0216326 (“Cross”)
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`1007
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`U.S. Provisional Application No. 62/378,939
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`1008
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`U.S. Patent Application Publication US 2018/0188108 (“Fawzy”)
`
`1009
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`U.S. Provisional Application No. 62/396,730
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`1010
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`U.S. Patent No. 5,690,417 (“Polidor”)
`
`1011
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`U.S. Patent Application Publication US 2015/0042877 (“O’Neill”)
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`1012
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`U.S. Patent No. 9,696,897 (“Garcia”)
`
`1013
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`U.S. Patent No. 6,208,749 (“Gutkowicz-Krusin”)
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`1014
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`U.S. Patent Application Publication US 2017/0236281 (“DaCosta”)
`
`
`
`i
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`Petitioner's Exhibit 1004
`Page 2 of 128
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`
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`1015
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`Extended Search Report issued March 7 2022 for EP application
`19837681 to Swift Medical Inc.
`
`1016 Web archive from The Wayback Machine – “What is an LED?”, All
`About LEDs, Adafruit Learning System
`
`1017 Web archive from The Wayback Machine – “Google Nexus 5
`Review”, Photography Blog, December 11, 2013
`
`1018 Web archive from The Wayback Machine – F-number,
`Wikipedia.com
`
`1019 Web archive from The Wayback Machine – Visible spectrum,
`Wikipedia.com
`
`
`
`ii
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`Petitioner's Exhibit 1004
`Page 3 of 128
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`I.
`
`INTRODUCTION
`1.
`I, Irene Georgakoudi, have been retained by Davidson Berquist
`
`Jackson & Gowdey LLP on behalf of MolecuLight, Inc., to provide an analysis of
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`the scope and content of U.S. Patent 11,266,345 (“the ’345 patent”) relative to the
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`state of the art at the time of the earliest application underlying ’345 patent. In
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`particular, my analysis relates to claims 1-20 of the ’345 patent. I have also been
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`retained to provide analysis regarding what a person of ordinary skill in the art
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`related to development of portable medical devices for imaging, including
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`attachments for imaging devices or adding aftermarket devices into such systems,
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`would have understood at the time of the earliest application underlying the ’345
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`patent.
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`2.
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`This report summarizes the opinions I have formed to date. I reserve
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`the right to modify my opinions, if necessary, based on further review and analysis
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`of information that I receive subsequent to the filing of this report, including in
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`response to positions taken by Swift Medical, Inc. or its experts that I have not yet
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`seen.
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`II. MY EXPERIENCE AND QUALIFICATIONS
`3.
`I have a B.A. in Physics with high honors from Dartmouth College in
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`Hanover NH, having achieved a magna cum laude ranking and been named a
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`Presidential Scholar. I earned a Ph.D. and M.Sc. in Biophysics from the School of
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`
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`1
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`Petitioner's Exhibit 1004
`Page 4 of 128
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`Medicine and Dentistry at the University of Rochester in Rochester, NY,
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`specializing in photodynamic therapy of cancer.
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`4.
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`From 1998-2022, I studied under an NIH Training Fellowship at the
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`Laser Biomedical Research Center of the Massachusetts Institute of Technology in
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`Cambridge, MA, where I specialized in biomedical spectroscopy and cancer
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`diagnostics.
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`5.
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`I am currently a Professor at Tufts University in Medford, MA in the
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`Biomedical Engineering Department and in the Program in Cell, Molecular and
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`Developmental Biology. I have held academic appointments at the Massachusetts
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`Institute of Technology in Cambridge, MA, Massachusetts General Hospital in
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`Boston, MA, Harvard Medical School in Boston, MA, and École Polytechnique,
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`Laboratoire d’Optique et Biosciences in Palaiseau, France.
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`6.
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`I earned several awards and honors for my work. In 2005, I earned the
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`Inaugural Sturge Price Award for “pioneering contributions to spectral diagnosis of
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`biological materials using optical spectroscopic methodology.” The Sturge Price
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`Award recognizes early career researchers for outstanding contributions in
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`condensed matter spectroscopy.
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`7.
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`From 2006-2011, I earned the NSF Career Award for non-invasive
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`modalities for optical imaging of cell-matrix interactions in engineered tissues. My
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`
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`2
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`Petitioner's Exhibit 1004
`Page 5 of 128
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`work for this award involved innovative, multidisciplinary studies at the interface
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`of optical non-invasive imaging and tissue engineering/regenerative medicine.
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`8.
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`In 2015, I was named a Fellow of the American Institute of Medical
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`and Biological Engineering. The American Institute of Medical and Biological
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`Engineering is a non-profit organization that represents the most accomplished
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`individuals in the fields of medical and biological engineering, and I was named as
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`Fellow due to my “outstanding contributions in to the development of label-free
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`optical methods for cancer diagnosis and tissue enginnering applications.”
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`9.
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`In 2016, I was named a Fellow of the Optical Society of America,
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`recently rebranded as Optica to reflect the more international membership and
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`impact of the Society. Optica is the leading organization for scientists, engineers,
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`business professionals, students and others interested in the science of light, and I
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`was named as Fellow due to my contributions “to the use of endogenous markers
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`for optical imaging of metabolic processes in normal and diseased tissue and for
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`tissue engineering.”
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`10.
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`In 2016, I was named a Senior Member of SPIE, The International
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`Society for Optics and Photonics and was named a Fellow of SPIE in 2020. SPIE
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`is an organization that partners with researchers, educators, and industry to
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`advance light-based research and technologies for the betterment of the human
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`
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`3
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`Petitioner's Exhibit 1004
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`condition; I was named as Fellow due to my contributions in spectroscopy and
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`imaging of collagen structure and metabolic processes in living tissues.
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`11. My work has allowed me to become familiar with the work and skill
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`of persons of ordinary skill in the field of optical devices, including for imaging
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`medical conditions, in the relevant time period prior to the ’345 patent’s filing date.
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`For example, in 2007, I have served as an external PhD thesis examiner for Lund
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`University in Lund, Sweden, which allowed me to evaluate the skill of Ph.D.
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`candidates at that time. I have also served as guest editor for Applied Optics
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`special issues in 2009 and 2011, which allowed me to evaluate the work of
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`academics and engineers in the field. Similarly, from, 2011 to 2017, I was an
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`associate editor at PLoS ONE, which was the first online only journal for
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`publication of studies of broad scientific interest and impact. In 2013 and 2015, I
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`was a guest editor for Biomedical Optics Express, a periodical focused on the
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`publication of optics and photonics advances in the field of biomedicine. Since
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`2017 I have been an associate editor for Optica, the second highest ranked journal
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`in the field of Optics and Photonics. For all these editorial roles, I assess the
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`novelty, rigor, and potential impact of the work described and make
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`recommendations regarding their publication.
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`12. As a leader in the field of biomedical optics I have served on the
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`program committee of numerous scientific conferences and I was in charge of the
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`4
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`Petitioner's Exhibit 1004
`Page 7 of 128
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`entire conference program for the European Conference on Biomedical Optics in
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`2013 and the Optics in Life Sciences Congress in 2017.
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`13. Since 2004 I have also served as a reviewer of articles describing
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`advances in optics and photonics with applications in biology and medicine
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`submitted for publication in journals of broad and high impact including Nature,
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`Nature Medicine, Nature Biomedical Engineering, Cell Reports, Biomedical
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`Optics Express, and Biophotonics Journal. In this role, I assessed the rigor or the
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`presented studies. In addition, I have been a member of numerous review panels
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`for the National Institutes of Health and the National Science Foundation, where I
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`assessed the merit of grant applications focusing on the development of methods
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`and devices to perform optical tissue assessments that can be used to improve
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`diagnosis or treatment of diseases.
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`14.
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`I have co-authored nearly 120 peer reviewed manuscripts and 9 book
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`chapters that describe advances in the use of optical methods to improve
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`understanding of tissue function, diagnosis, and treatment of diseases. My research
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`explores fundamental advances and translational applications of optical methods in
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`cancer, cardiovascular and neurodegenerative diseases, obesity, osteoarthritis,
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`tissue engineering and regenerative medicine. Many of my studies are performed
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`in collaboration with scientists, engineers, and clinicians and involve studies
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`isolated cells and tissue components, tissues, animals and humans. In the specific
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`
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`5
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`Petitioner's Exhibit 1004
`Page 8 of 128
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`context of wound healing, I was a senior author of a manuscript presenting our
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`work on the use of endogenous fluorescence and scattering based microscopic
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`imaging to characterize diabetic wounds that appeared in the Journal of
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`Investigative Dermatology in 2016. My manuscripts have been cited by over
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`11,000 peer-reviewed studies. I have given numerous invited keynote and plenary
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`presentations on optical tissue assessments at national and international meetings,
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`as well as department seminars throughout the world.
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`15.
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`I have been awarded eleven U.S. patents, including U.S. Patent
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`6,697,652 titled “Fluorescence, reflectance and light scattering spectroscopy for
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`measuring tissue” and U.S. Patents 6,912,412 and 8,380,268 titled “System and
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`methods of fluorescence, reflectance and light scattering spectroscopy for
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`measuring tissue characteristics.”
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`16. For a more complete listing of items in my biography in the field, a
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`true and accurate copy of my curriculum vitae will be provided in this proceeding
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`as Ex. 1005.
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`III. STATUS AS AN INDEPENDENT EXPERT
`17. As noted above, I have been retained in this matter by Davidson
`
`Berquist Jackson & Gowdey LLP on behalf of MolecuLight, Inc. (the
`
`“Petitioner”), to provide an analysis of the scope and content of the ’345 patent
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`relative to the state of the art at the time of the earliest application underlying the
`
`
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`6
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`Petitioner's Exhibit 1004
`Page 9 of 128
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`’345 patent. In particular, I have been retained to provide analysis regarding what a
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`person of ordinary skill in the art related to the field of optical devices, including
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`for imaging medical conditions, would have understood at the time of the earliest
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`application underlying the ’345 patent.
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`18.
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`I am being compensated at hourly rates depending on the type of work
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`I perform for this case and for travel time. No part of my compensation is
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`contingent on the outcome of any matter or of any of the technical positions I
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`explain in this declaration. I have no financial interest in the Petitioner.
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`19.
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`I have been informed that Swift Medical, Inc. (the “Patent Owner”)
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`owns the ’345 patent. I have no financial interest in the Patent Owner or the ’345
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`patent, nor to my recollection have I ever had any contact with the Patent Owner or
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`the listed inventors of the ’345 patent.
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`IV. MATERIALS CONSIDERED AND BASIS OF OPINIONS
`20. My opinions set forth herein are based on more than 31 years of
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`working with optical devices, and more than 26 years of working with optical
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`devices for medical imaging of tissue, as well as my teaching and work experience
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`in the medical imaging field. My opinions are also based upon investigation and
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`study of the relevant materials including the ’345 patent at issue and its file history,
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`prior art references, and the exhibits of record in the Petition.
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`7
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`Petitioner's Exhibit 1004
`Page 10 of 128
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`21.
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`I may rely upon these materials and/or additional materials to rebut
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`arguments raised by the Patent Owner. Further, I may also consider additional
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`documents and information in forming any necessary opinions – including
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`documents that may not yet have been provided to me.
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`22. My analysis of the materials relevant to this proceeding is ongoing,
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`and I will continue to review any new material as it is provided. This declaration
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`presents only those opinions I have formed to date. I reserve the right to revise,
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`supplement, and/or amend my opinions stated herein based on new information,
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`and on my continuing analysis of the materials already provided.
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`23.
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`I have carefully reviewed the ’345 patent. For convenience, all the
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`information that I considered in arriving at my opinions are listed in the
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`Petitioner’s Exhibit List provided above.
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`V. OVERVIEW OF THE ’345 PATENT
`24.
` The ’345 patent suggests a need for a medical diagnostic tool that
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`can be carried to a patient’s home, remote community, or outpatient facility. ’345
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`patent, 4:60-67. The tool can be used to detect diabetic foot ulcers, a disabling and
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`costly complication of diabetes, or other medical conditions. ’345 patent, 5:1-7.
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`25. The ’345 patent refers to that tool as a “tissue imaging system” and
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`Fig. 1 (reproduced below) depicts an example of the overall system architecture for
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`use with such tissue imaging systems.
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`8
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`Petitioner's Exhibit 1004
`Page 11 of 128
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`26.
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`In Fig. 1, an example tissue visualization system 100 connects to
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`tissue imaging systems 105 via network 110. ’345 patent, 6:40-42. A tissue
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`imaging system 105 may comprise a mobile device 108, a combination of a mobile
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`device 108 and an illumination unit 104, a combination of a mobile device 108 and
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`an imaging unit 103, or a combination of a mobile device 108 and a combined or
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`separate imaging unit 103 and illumination unit 104. ’345 patent, 6:51-57, 7:10-24.
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`In an example embodiment discussed in this summary, mobile device 108
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`comprises a smartphone. ’345 patent, 6:61:62.
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`27.
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`Image capturing unit 103 captures images, using a 3 channel (RGB) or
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`4 channel (RGB-NIR) camera for example. ’345 patent, 7:1-5. Illumination unit
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`9
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`Petitioner's Exhibit 1004
`Page 12 of 128
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`104 is capable of illuminating a target area with required intensity, wavelengths,
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`and duration, such as a multispectral flash. ’345 patent, 7:6-10. The illumination
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`unit 104 can include a lighting unit 300, which may include multiple light sources
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`300 (see Fig. 3 of the ’345 patent) and may be connected to the smartphone
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`through a connector 302 to act as an external flash-generating device. ’345 patent,
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`11:38-44. Light units 300 can be arranged in a circular configuration around a
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`central aperture. ’345 patent, 11:44-48.
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`28. The illumination unit 104 can produce a sequence of flashes of
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`predetermined length. ’345 patent, 18:16-17. Fig. 7 of the ’345 patent (reproduced
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`below) provides an example of an illumination and image capturing schema, which
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`accounts for external illumination (’345 patent, 17:10-15):
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`10
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`Petitioner's Exhibit 1004
`Page 13 of 128
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`29. Fig. 7 plots the flash 702 coordinated by illumination unit 104, as a
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`function of time. The ’345 patent states that “[a]s shown at 702, the illumination
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`schema (cycle) consists of m flashes (with m=2 in the example of Fig. 7) and one
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`period without flash, with n/4≤m≤n, where n is the number of wavelengths.” ’345
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`patent, 17:19-23. The ’345 patent defines “[a] wavelength” with regard to a flash
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`as referring “to light sources shining at the same wavelength, or the possibility of
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`multiple wavelengths shining in a single flash.” ’345 patent, 18:17-20 (stating
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`“[e]ach of the flashes may shine at 1-4 particular wavelengths.”).
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`30. The ’345 patent also contemplates “an illumination schema where
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`each wavelength shines sequentially (n=m, where n is the number of wavelengths,
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`m is the number of flashes in one cycle).” ’345 patent, 18:65-19:2.
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`
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`11
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`Petitioner's Exhibit 1004
`Page 14 of 128
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`31. Fig. 8 of the ’345 patent provides examples of illumination units
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`(reproduced below):
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`
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`32. The illumination unit 104 can be an external flash device attached to a
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`smartphone or built into its case. ’345 patent, 17:51-58. The illumination unit 104
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`be associated with the smartphone by way of a spring clip (views 804 and 806), a
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`compression clip (view 802), or other means 302 that can be attached to the
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`smartphone. ’345 patent, 18:4-15.
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`VI. LEGAL STANDARDS FOR UNPATENTABILITY IN THE PRESENT
`PROCEEDINGS
`33.
`I am informed by counsel and understand that statutory and judicially
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`created standards must be considered to determine the validity of a patent claim. I
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`12
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`Petitioner's Exhibit 1004
`Page 15 of 128
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`have reproduced the legal standards relevant to this declaration below, as provided
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`to me by counsel as I understand them.
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`34.
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`I understand that a patent claim is invalid based on prior art if it is
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`anticipated or obvious. A patent claim can also be invalid if it is indefinite or if it
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`lacks an adequate written description in the specification.
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`35. Claim Construction: I am informed that in performing an invalidity
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`analysis, it is necessary to understand the scope of the claims. I am also informed
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`the first step in an unpatentability analysis, therefore, involves construing the
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`claims. The construed claim language can then be compared to the disclosures of
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`the prior art.
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`36.
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`I am informed that claims are generally given their ordinary and
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`custom meaning as understood by one of ordinary skill in the art at the time of the
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`invention, in light of the patent specification. I am informed that, for the purposes
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`of claim construction, expert testimony may be helpful to provide background on
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`the technology at issue, to explain how an invention works, to ensure an
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`understanding of the technical aspects of the patent is consistent with that of a
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`person having ordinary skill in the art, or to establish that a particular term in the
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`patent had a particular meaning in the pertinent field at the time of the invention.
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`However, I am also informed testimony from a technical expert is generally less
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`13
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`Petitioner's Exhibit 1004
`Page 16 of 128
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`reliable than the patent itself and its prosecution history in determining the
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`meaning of claim terms.
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`37. Anticipation: I understand that for a patent claim to be “anticipated”
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`by the prior art, each and every limitation of the claim must be found, expressly or
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`inherently, in a single prior art reference as recited in the claim. I understand a
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`claim limitation not expressly found in a prior art reference is inherent if the prior
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`art necessarily functions in accordance with, or includes, the claim limitation. Mere
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`probability that a limitation is included is not sufficient to establish inherency.
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`38.
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` Obviousness: I understand that a patent claim is not patentable for
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`obviousness under 35 U.S.C. § 103 “if the differences between the subject matter
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`sought to be patented and the prior art are such that the subject matter as a whole
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`would have been obvious at the time the invention was made to a person having
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`ordinary skill in the art to which said subject matter pertains.” 35 U.S.C. § 103. I
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`understand that obviousness may be based on one reference and/or a combination
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`of references. I understand that the combination of familiar elements according to
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`known methods is likely to be obvious when it does no more than yield predictable
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`results.
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`39.
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` I understand that when a patented invention is a combination of
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`known elements, the Board must determine whether there was an apparent reason
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`to combine the known elements in the fashion claimed by the patent at issue by
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`
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`14
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`Petitioner's Exhibit 1004
`Page 17 of 128
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`considering the teachings of prior art references, the effects of demands known to
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`people working in the field or present in the marketplace, and the background
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`knowledge possessed by a person having ordinary skill in the art.
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`40.
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`I understand that a patent claim composed of several limitations is not
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`proven obvious merely by demonstrating that each limitation was independently
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`known in the prior art. I understand that identifying a reason those elements would
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`have been combined can be important because inventions in many instances rely
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`upon building blocks long since uncovered and claimed discoveries almost of
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`necessity will be combinations of what, in some sense, is already known. I
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`understand that it is improper to use hindsight in an obviousness analysis and that a
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`patent's claims should not be used as a “roadmap.”
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`41.
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`I also understand all prior art references are to be considered from the
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`viewpoint of a person having ordinary skill in the art at the time the invention was
`
`made.
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`42.
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`I understand that obviousness analysis requires consideration of: (1)
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`the scope and content of the prior art; (2) the differences between the claims and
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`the prior art; (3) the level of ordinary skill in the pertinent art; and (4) any objective
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`indicia of non-obviousness, such as commercial success, long-felt but unresolved
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`need, failure of others, industry recognition, copying, and unexpected results.
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`15
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`Petitioner's Exhibit 1004
`Page 18 of 128
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`43.
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`I understand that in order to prove that a claimed invention is not
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`patentable for obviousness, a petitioner must (1) identify the differences between
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`the claim and particular disclosures in the prior art references, singly or in
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`combination, (2) specifically explain how the prior art references could have been
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`combined in order to arrive at the subject matter of the claimed invention, and (3)
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`specifically explain why a person having ordinary skill in the art would have had
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`reasons to so combine the prior art references.
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`44. Analogous Art: I am informed that for a prior art reference to be
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`proper for use in an obviousness analysis, the reference must be “analogous art” to
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`the claimed invention. I am informed that a reference is analogous art to the
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`claimed invention if: (1) the reference is from the same field of endeavor as the
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`claimed invention (even if it addresses a different problem); or (2) the reference is
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`reasonably pertinent to the problem faced by the inventor (even if it is not in the
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`same field of endeavor as the claimed invention). In order for a reference to be
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`“reasonably pertinent” to the problem, it must logically have commended itself to
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`an inventor's attention in considering the inventor’s problem. In determining
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`whether a reference is reasonably pertinent, one should consider the problem(s)
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`faced by the inventor, as reflected either explicitly or implicitly, in the
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`specification. Such problems are not limited to those solved by the purported
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`16
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`Petitioner's Exhibit 1004
`Page 19 of 128
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`invention, but the general problem(s) that confronted the inventor before the
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`invention was made.
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`45.
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`Indefiniteness: I have been informed that a patent claim is indefinite
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`where, when interpreted in light of the specification and the prosecution history,
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`the claim fails to inform those skilled in the art about the scope of the invention
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`with reasonable certainty.
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`46. Written Description: I understand that a patent claim fails to satisfy
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`the written description requirement where the specification does not describe the
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`claimed invention in sufficient detail that one skilled in the art can reasonably
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`conclude that the inventor had possession of the claimed invention at the time of
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`filing.
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`VII. THE PERSON OF ORDINARY SKILL IN THE RELEVANT FIELD
`IN THE RELEVANT TIME FRAME
`47.
` I have been informed that “a person of ordinary skill in the art”
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`(sometimes abbreviated as a “POSITA”) is a hypothetical person to whom an
`
`expert in the relevant field could assign a routine task with reasonable confidence
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`that the task would have been successfully carried out. I have been informed that
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`evidence of the level of ordinary skill in the art can be determined based on
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`information about the field including: the types of problems encountered, known
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`solutions, the speed of innovation, sophistication, and the educational level of
`
`active workers. I have considered these types of information along with my own
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`background in optical devices for medical imaging of tissue with other professors,
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`students, postdoctoral trainees, research associates, industry collaborators, and
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`other professionals in the field to reach my conclusion.
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`48.
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`It is my opinion, that a POSITA at the time of the purported invention
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`would have had at least a bachelor’s degree in engineering with relevant
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`coursework, and the equivalent of at least two years of work experience in the
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`design, operation, and functioning of imaging systems, amounting to familiarity
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`with concepts related to illumination and detection schemes for optical imaging
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`systems. Additional relevant work experience could substitute for a bachelor’s
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`degree, and additional education or training could substitute for relevant work
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`experience.
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`49. Based on my extensive teaching and mentoring experience and my
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`activities in the field summarized above, I have an understanding of the capabilities
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`of a person of ordinary skill in the relevant field. I have worked with, supervised,
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`directed, and instructed many such persons over the course of my career. At the
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`time of filing of the ’345 patent, I possessed at least the same level of skill as a
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`POSITA.
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`VIII. CLAIM CONSTRUCTION
`50. For the purposes of my analysis below, I have reviewed the claim
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`language, the specification, and the prosecution history. I do not believe that any of
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`the claim terms require a specific construction beyond the plain and ordinary
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`meaning as would be understood by a POSITA. Thus, my analysis below will
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`explain how the references satisfy the plain and ordinary meaning of the claims as
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`would be understood by a POSITA at the time of the invention.
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`51.
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` Nevertheless, should the Board wish to construe “a central aperture of
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`the illumination unit” in claim 5 and “proper distance” in claim 13, I offer the
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`following opinions.
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`52. With regard to “a central aperture of the illumination unit,” the
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`specification of the ’345 patent only uses the term “central aperture” in the
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`summary of the invention (“the one or more light sources are arranged along a
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`central aperture having a radius of 0.5-3 cm”) (‘345 patent, 2:57-59) (emphasis
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`added) and when describing an embodiment where “light units 300 are arranged in
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`a circular configuration around a central aperture” (11:46-48). A POSITA
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`would understand from these disclosures that the “central aperture of the
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`illumination unit” includes an aperture lying at the center of an arrangement of
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`light units such that the claimed “light sources” are concentric with the central
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`aperture. A POSITA would not understand the recitation “of the illumination unit”
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`to require that the central aperture lies at the geometric center of the housing of an
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`illumination unit (although the central aperture could be at the geometric center of
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`the housing of the illumination unit, as depicted in Fig. 8 of the ’345 patent).
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`Rather, the recitation “of the illumination unit” merely describes on which
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`component the “central aperture” is located.
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`53. With regard to the term “proper distance,” the specification defines
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`“proper distance” as including a “working distance.” ’345 patent, 14:48-50
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`(“positioned at a proper distance (working distance) in relation to an area of
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`tissue”) (emphasis added). A POSITA would understand that the positioning
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`merely locates the claimed computing device at a location where a medically-
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`relevant image of tissue may be captured, that is, that the device works to capture a
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`medically-relevant image. The requirement in claim 13 to position the computing
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`device at a proper distance from the target area of the tissue does not require any
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`steps to confirm, verify, or measure that the computing device is, in fact,
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`positioned properly, as claim 13 states nothing about confirming, verifying, or
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`measuring the distance.
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`54.
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`I have been informed that there is a legal doctrine known as “means-
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`plus-function,” codified in 35 U.S.C. § 112(f), that can limit the scope of claims. I
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`also understand that because none of the claim elements recite the terms “means”
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`or “step,” there is a presumption that § 112(f) does not apply.
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`55.
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`I understand that the Examiner construed the terms “image capturing
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`unit” in claims 1, 8, 10, and 13, “controller” in claim 4, and “communication(s)
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`module” in claims 11 and 12 under § 112(f). The Examiner also felt that the term
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`“illumination unit” in claims 1, 8, 10, 13, 15, and 17 did not invoke § 112(f)
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`because the claims recite “one or more narrow band light sources” and that the
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`term “image capture unit in claim 9 did not invoke § 112(f) because the claim
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`recites “a camera.” See Ex. 1002 at 75-77.
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`56.
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`It is my opinion that each of the elements in the claims itself connotes
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`some structure to a person of ordinary skill in the art and that § 112(f) should not
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`apply.
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`57.
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`I also believe that the issue of § 112(f) does not materially change my
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`analysis, as the references I apply below disclose the same or equivalent structures
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`as found in the specification of the ’345 patent for performing the claimed
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`functions. For the sake of completeness, I provide the following analysis of the
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`terms construed by the Examiner to invoke § 112(f).
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`58. A POSITA would interpret the function corresponding to the term
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`“image capturing unit” in claims 1, 8, 10, and 13 to be “capturing an image” and
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`that the structure for capturing an image in the ’345 patent includes a “camera”
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`(claim 9), a “smartphone camera (front or back)” (11:29-30), “an internal … or
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`external device capable of capturing images” (7:1-3), and a “3 channel (RGB) or 4
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`channel (RGB-NIR) camera” (7:3-5), or its equivalents.
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`59. A POSITA would interpret the function corresponding to the term
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`“controller” in claim 4 to be “control[ling] illumination of the one or more light
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`sources” and that the structure for controlling illumination of the one or more light
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`sources in the ’345 patent includes “any type of general-purpose microprocessor or
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`microcontroller, a digital signal processing (DSP) processor, an integrated circuit, a
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`central processing unit (CPU), a graphics processing unit (GPU), a field
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`programmable gate array (FPGA), a reconfigurable processor, a programmable
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`read-only memory (PROM), or any combination thereof” (11:61-12:5), or its
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`equivalents.
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`60. A POSITA would interpret the function corresponding to the term
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`“wireless communication module” in claim 11 to be “receiving commands from
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`the computing device” and that the structure for receiving commands from the
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`computing device in the ’345 patent includes “known … wireless communications
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`protocols” (7:22-24) and “known wireless connections (for example,
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`Bluetooth™)” (7:29-34, 17:53-56); “Bluetooth, …, WiFi, near-field
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`communication” (11:54-56), or its equivalents.
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`61. A POSITA would interpret the function corresponding to the term
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`“communications module” in claim 12 to be “communicating with the one or more
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`tissue imaging systems” and that the structure for communicating with the one or
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`more tissue imaging systems in the ’345 patent includes a “data I/O unit” (8:35-36,
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`9:49-51) allowing “wired connections, wireless connections, or a combination
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`thereof” and “di
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