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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`APPLE, INC.,
`Petitioner,
`v.
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`ALIVECOR, INC.,
`Patent Owner.
`___________
`Case IPR2021-00972
`U.S. Patent No. 10,638,941
`___________
`
`DECLARATION OF DR. IGOR EFIMOV IN SUPPORT OF
`PATENT OWNER’S PRELIMINARY RESPONSE
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`AliveCor Ex. 2001 - Page 1
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`I.
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`INTRODUCTION
`1.
`I, Igor R Efimov, Ph.D., have been retained by AliveCor, Inc.
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`(“AliveCor” or “Patent Owner”) to provide certain expert opinions in connection
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`with AliveCor’s Patent Owner Preliminary Response to the Petition for Inter
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`Partes Review of U.S. Patent No. 10,638,941 (“the ‘941 patent”), IPR2021-00972
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`(“the 972 Petition”) filed by Apple, Inc. (“Apple” or “Petitioner”).
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`II. BACKGROUND AND QUALIFICATIONS
`2.
`I am the Alisann and Terry Collins Professor of Biomedical
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`Engineering at the George Washington University, Washington, D.C. From
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`January 2015 to December 2019, I served as the founding chairman of the
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`Department of Biomedical Engineering at the George Washington University.
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`Previously, from 2004 to 2015, I served as the Lucy & Stanley Lopata
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`Distinguished Professor of Biomedical Engineering at Washington University in
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`Saint Louis, Missouri. I was also a Professor of Medicine, Professor of
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`Radiology, and Professor of Cell Biology & Physiology at the Washington
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`University School of Medicine. I also served on the faculty of the Department of
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`Cardiology of the Cleveland Clinic Foundation (1994-2000) and Department of
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`Biomedical Engineering of Case Western Reserve University (2000-2004),
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`Cleveland Ohio.
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`3.
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`I received my Master of Science degree in experimental nuclear
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`physics from the Moscow Institute of Physics and Technology, USSR in 1986. In
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`1992, I further received a Ph.D. in Biophysics from the Moscow Institute of
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`Physics and Technology, after completing a doctoral study on the mechanisms of
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`sudden cardiac death due to ventricular arrhythmias. I completed my postdoctoral
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`training in 1992-1994 in the field of cardiac electrophysiology and arrhythmia at
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`the University of Pittsburgh in Pittsburgh, Pennsylvania. Then, I started my
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`independent cardiac research career in the Department of Cardiology at the
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`Cleveland Clinic Foundation (1994-2000), where I established an NIH-funded
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`laboratory. Cleveland Clinic has been consistently ranked #1 Cardiology program
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`nationwide since 1994 by the U.S. News & World Report.
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`4.
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`For the past 21 years I have taught undergraduate and graduate
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`courses in Biomedical Engineering at Case Western Reserve University,
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`Washington University in St. Louis, and the George Washington University,
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`including BME 301B Quantitative Physiology, BME 573 Applied Bioelectricity,
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`BME 5909 Physiology of the Heart, BME 1010 Introduction to Biomedical
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`Engineering, BME 3907 Clinical Cardiovascular Engineering, and BME 6045
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`Cardiovascular Engineering & Technology. In these and other courses, I taught
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`sections on engineering and physiological principles of cardiac electrophysiology,
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`arrhythmia, and electrocardiography. Many of my trainees are currently working
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`at leading national medical device companies such as Medtronic, St. Jude
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`Medical, Philips Medical, and Boston Scientific, developing novel cardiac
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`antiarrhythmic therapy and diagnostics devices.
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`5.
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`I also mentored over 30 clinical fellows and postdoctoral research
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`fellows, many of whom are currently professors, cardiologists, cardiac surgeons,
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`and clinical engineers throughout the national and world Universities and
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`hospitals, including Harvard University, MA; University of California, CA; Ohio
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`State University, OH; University of Wisconsin, WI; University of Fukuoka,
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`Japan; University of Bordeaux, France; University of Brno, Czech Republic;
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`Imperial College London, U.K; etc.
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`6.
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`I have published a book in 2009 on cardiac bioelectric diagnostics
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`and therapy (Efimov I.R., Kroll, M.W., Tchou, P.J., Eds., Cardiac Bioelectric
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`Therapy: Mechanisms and Practical Implications, Springer, 2009. ISBN 978-0-
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`387-79402-0), and I have just published a second updated edition of this book in
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`2021 (Efimov I.R., Ng F.S., Laughner J.I., Eds., Cardiac Bioelectric Therapy:
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`Mechanisms and Practical Implications, Springer, 2nd Edition. 2021. ISBN 978-
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`3-030-63354-7).
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`7. Most of my 260+ peer-reviewed publications focus on the
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`physiological mechanisms of cardiac arrhythmias, its diagnostics and therapy. In
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`collaboration with Professor John A. Rogers, we have developed novel
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`implantable, interventional, and wearable electronics platform for monitoring
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`cardiac electrophysiology, diagnosis of heart rhythm disorders due to brady- and
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`tachyarrhythmias and antiarrhythmia therapy. Several high impact publications
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`have been published on that subject recently in leading scientific journals of
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`Nature family. For example, our recent paper on novel bioresorbable electronics
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`platform (Choi YS, Yin RT, Pfenniger A, Koo H, Avila R, Lee KB, Chen SW,
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`Lee G, Li G, Qiao Y, Murillo-Berlioz A, Kiss A, Han S, Lee SM, Li C, Xie Z,
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`Chen YY, Burrell A, Geist B, Jeong H, Kim J, Yoon HJ, Banks A, Kang SK,
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`Zhang ZJ, Haney CR, Sahakian AV, Johnson D, Efimova T, Huang Y, Trachiotis
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`GD, Knight BP, Arora RK, Efimov IR, Rogers JA. Fully implantable and
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`bioresorbable cardiac pacemakers without leads or batteries. Nature
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`Biotechnology, June 28, 2021, https://doi.org/10.1038/s41587-021-00948-x.) was
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`featured by over 150 international news outlets reaching at least 12 million
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`listeners/viewers from 5 continents, including PBS, Guardian, and NIH Research
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`Matters (NIH Director’s office online publication).
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`8.
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`I have also delivered 360+ invited lectures at prestigious professional
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`conferences and leading Universities worldwide, most of them on cardiac
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`arrhythmias and therapy.
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`9.
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`I am currently serving 5-year term as the Editor-in Chief of
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`Cardiovascular Engineering and Technology, journal of Biomedical Engineering
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`Society published by SpringerNature. I am responsible for review and publishing
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`decision making of approximately 200-250 manuscripts submitted for publication,
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`including cardiac electrophysiology, signal processing, arrhythmia therapy, etc. I
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`have served on the editorial board of the American Journal of Physiology: Heart
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`and Circulatory Physiology and Heart Rhythm Journal, where I manage and make
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`decisions on manuscripts related to cardiac electrophysiology and electrotherapy.
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`I have served or currently am serving on many editorial boards of leading cardiac
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`journals, where I review papers on cardiac electrophysiology and arrhythmia.
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`These journals include Circulation Research, Heart Rhythm, Journal of Cardiac
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`Electrophysiology, Journal of Molecular and Cellular Cardiology, American
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`Journal of Physiology, IEEE Transactions in Biomedical Engineering,
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`Experimental Physiology, etc.
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`10.
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`I have served on numerous national and international expert panels,
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`which consider grant applications from the leading experts in the field of cardiac
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`electrophysiology and defibrillation, from many countries, including the USA,
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`Canada, the UK, France, Switzerland, Germany, the Netherlands, Russia,
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`Australia, New Zealand, South Africa, Singapore, etc. From 2009-2013, I served
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`as a chartered member of the leading US panel at the National Institutes of Health,
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`the Electrical Signaling, Transporters and Arrhythmia (ESTA) Study section,
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`which is the major source of funding to leading US cardiac arrhythmia
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`investigators.
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`11. My research on heart rhythm disorders has been funded by the
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`National Heart, Lung, and Blood Institute of the National Institutes of Health and
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`other federal and private foundations without interruptions since 1998, with an
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`average of approximately $1M per year during recent years. I am also funded by
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`the American Heart Association, National Science Foundation, Leducq
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`Foundation, etc.
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`12.
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`I have served on many international panels that consider policy,
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`research, and funding decisions in the field of cardiac electrophysiology and
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`therapy in numerous countries from most continents. Recently, I served on The
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`Expert Panel on the Medical and Physiological Impacts of Conducted Energy
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`Weapons of the Council of Canadian Academies.
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`13.
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`I have been designing medical devices, for over 25 years. With the
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`support of NIH funding, I have invented a method for low-voltage defibrillation of
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`cardiac arrhythmias by effectively unpinning anatomical reentry (U.S. Patent No.
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`8,175,702), a method for cardiac pacing using the inferior nodal extension (US
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`Patent US No 8,391,995 B2), and a method and device for low-energy termination
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`of atrial tachyarrhythmias (US Patent No US 8,509,889 B2). I founded Cardialen,
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`Inc. to develop clinical defibrillator based on this method, which received over
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`$30M in venture and NIH funding.
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`14.
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`In recognition of my research and innovation in the field of heart
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`rhythm disorders, I have been elected to the United States National Academy of
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`Inventors in 2019; and I have received 2021 Distinguished Scientist Award from
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`the leading clinical cardiac electrophysiology professional association - Heart
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`Rhythm Society.
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`15. My professional history is further detailed in the provided curriculum
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`vita (see Appendix).
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`16. My conclusions in this report and my compensation do not depend on
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`the outcome of the case. My hourly rate is $500/hour for report preparation and
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`$550 for testimony in deposition/trial/arbitration.
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`17.
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`In preparing this declaration, I have considered the claims and
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`specifications for the ‘941 patent as well as the claims and specifications for U.S.
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`Patent Nos. 9,572,499 (“the ‘499 patent”) and 10,593,731 (“the ‘731 patent”)
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`(collectively, “the AliveCor Patents”) from the vantage point of one of ordinary
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`skill in the art. I have also reviewed the 972 Petition, the Declaration of Dr.
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`Bernard R. Chaitman filed in support of the 972 Petition, and all exhibits cited
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`herein.
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`18.
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`I reserve the right to modify or supplement my Declaration or the
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`bases for my opinions in light of any additional documents, depositions and other
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`testimony, or other evidence that may become available to the extent the 972
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`Petition progresses. I also may be asked to respond to any declarations or
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`testimony submitted on behalf of Petitioner concerning the patents-in-suit, state of
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`the art or other matters, as well as any rulings of the Patent Trial and Appeal
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`Board related to the 972 Petition, and reserve the right to do so.
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`III. LEGAL STANDARDS
`A. Claim Construction
`19.
`I understand that the claims should be construed from the standpoint
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`of a hypothetical person of ordinary skill in the art (“POSITA”) as of the invention
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`date of the asserted patent. I understand that the following factors are relevant to
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`determining the level of ordinary skill in the art: (a) type of problems encountered
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`in the art, (b) prior art solutions to those problems, (c) rapidity with which
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`innovations are made, (d) sophistication of the technology, and (e) educational
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`level and/or experience of active workers in the field.
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`20.
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`I understand that the claims of a patent define its scope, and the
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`construction of claim terms is a question of law. I also understand that claim
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`construction is a process that begins with the claims of the patent that define the
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`invention. The claims are given their ordinary and customary meaning as
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`understood by a person of ordinary skill in the art when read in the context of the
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`specification and prosecution history. In determining the proper construction of
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`the claims, courts apply a hierarchy of intrinsic record: (1) the claim language, (2)
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`the specification, and (3) the prosecution history. It is my understanding that
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`extrinsic evidence, such as expert testimony, dictionaries, and learned treatises,
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`can be used if claim terms remain ambiguous but extrinsic evidence cannot be
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`used to contradict the intrinsic evidence.
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`21.
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`I understand that the written description of the invention in the patent
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`specification is of paramount importance in construing the claims. The
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`specification is the single best guide to the meaning of a disputed term and is
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`usually dispositive. While the specification is a guide when construing claims,
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`specific embodiments should not be read into claims.
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`22.
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`I understand that an inventor may act as his or her own lexicographer
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`and provide definitions for terms used in a patent. I also understand that when the
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`specification shows that the inventors gave a special definition to a claim term that
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`differs from the meaning it would otherwise possess, that definition controls the
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`meaning of the term.
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`23.
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`I understand that a claim construction should give meaning to all of
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`the terms in the claim. Constructions that render a claim term(s) superfluous are
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`generally rejected. Each claim term is also presumed to have a distinct meaning
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`and scope.
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`24.
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`I understand that an element in a claim for a combination may be
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`expressed as a means or step for performing a specified function (“means plus
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`function”) without the recital of structure, material, or acts in support thereof, and
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`such claim shall be construed to cover the corresponding structure, material, or
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`acts described in the specification and equivalents thereof.
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`25.
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`I also understand that there is a rebuttable presumption afforded the
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`patent drafter that claim language is not “means plus function” if it does not
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`include the word “means.” I also understand that the presumption can be
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`overcome only if the challenger demonstrates that the claim term fails to recite
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`sufficiently definite structure or else recites function without reciting sufficient
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`structure for performing that function. In such cases, a substitute term acts a
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`generic placeholder (or so-called “nonce” word) for the term “means.” I
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`understand that the standard is whether a person of ordinary skill in the art would
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`understand the claim language to refer to structure, assessed in light of the
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`presumption that flows from the drafter's choice not to employ the word “means.”
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`B. Anticipation
`26.
`I understand that a claim is anticipated only if each and every single
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`element as set forth in the claim is found, either expressly or inherently described,
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`in a single prior art reference.
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`27.
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`I understand that inherency may not be established by probabilities or
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`possibilities, and the mere fact that a certain thing may result from a given set of
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`circumstances is not sufficient for anticipation.
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`28.
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`I understand that to serve as an anticipating reference, the reference
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`must fully enable that which it is asserted to anticipate. I further understand that a
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`claimed invention cannot be anticipated by a prior art reference if the allegedly
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`anticipatory disclosures cited as prior art are not enabled. I further understand that
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`enablement requires that the prior art reference must teach one of ordinary skill in
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`the art to make or carry out the claimed invention without undue additional
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`experimentation.
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`29.
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`I understand that determination of whether the requisite amount of
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`experimentation is undue may include consideration of several factors (known as
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`the Wands factors). Those factors include: (1) the quantity of experimentation
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`necessary, (2) the amount of direction or guidance presented, (3) the presence or
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`absence of working examples, (4) the nature of the invention, (5) the state of the
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`prior art, (6) the relative skill of those in the art, (7) the predictability or
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`unpredictability of the art, and (8) the breadth of the claims.
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`30.
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`It is my understanding that neither Apple nor Dr. Chaitman are
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`asserting any anticipation invalidity positions against the ‘941 patent in the 972
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`Petition.
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`C. Obviousness
`31.
`I understand that an analysis of obviousness must include an analysis
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`of (1) the scope and content of the prior art; (2) the differences between the prior
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`art and the claims at issue; (3) the level of ordinary skill in the art at the time the
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`invention was made; and (4) objective evidence of nonobviousness, if any.
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`32.
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`I further understand that there must be some articulated reasoning
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`with some rational underpinning to support the legal conclusion of obviousness. I
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`further understand that the patent challenger must demonstrate a “reasonable
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`expectation of success” of combining the prior art references to achieve the
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`claimed invention.
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`33.
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`I also understand that a patent can be obvious in light of a single prior
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`art reference if it would have been obvious to modify that reference to arrive at the
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`patented invention.
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`34.
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`I understand that in evaluating prior art, a person of ordinary skill in
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`the art (“POSITA”) must avoid the trap of hindsight. I further understand that
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`even an obvious solution does not render an invention obvious if the problem
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`solved was previously unknown.
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`35.
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`I further understand that a reference that teaches away cannot serve
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`as a basis for obviousness. I further understand that a reference may be said to
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`teach away when a person of ordinary skill, upon reading the reference, would be
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`discouraged from following the path set out in the reference, or would be led in a
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`direction divergent from the path that was taken by the applicant.
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`36.
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`I further understand that evidence of “secondary considerations”
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`when present must always be considered in a determination of obviousness. I
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`understand that these objective considerations, when considered with the balance
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`of the obviousness evidence in the record, guard as a check against hindsight bias.
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`IV. BACKGROUND
`37. Cardiovascular diseases are considered to be one of the leading
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`causes of death in the World, and the ‘941 patent teaches that irregular heartbeats
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`and arrhythmias in particular, including atrial fibrillation and supraventricular
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`tachycardia, are associated with significant morbidity and mortality in patients.
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`Ex. 1001 at 1:17-18
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`38. The ‘941 patent teaches that arrythmias may occur continuously and
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`intermittently, and a particularly difficult type of arrhythmia to diagnose is
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`intermittent arrhythmia. Id. at 1:19-20, 49-53. In order to accurately diagnose
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`intermittent arrhythmia, the ‘941 patent explains that a given diagnostic technique
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`utilized cannot be applied at any time, but must be applied at a time when the
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`individual is experiencing an arrhythmia. Id. at 1:34-49. This diagnostic difficulty
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`is often compounded because a patient may not be aware that he or she is
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`experiencing an intermittent arrhythmia. Id. at 1:53-57.
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`39. Thus, in order to capture an intermittent arrhythmia, the ‘941 patent
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`explains that continuous monitoring has generally been required, and historically,
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`continuous measurements in an ambulatory patient has required recording ECG
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`measurement through the use of a bulky and cumbersome holter monitoring
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`devices. Id. at 4:15-20.
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`40. A photoplethysmogram (PPG) sensor can, among other things,
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`monitor heart rate using an optical detection of blood volume changes in the
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`microvascular bed of the tissue. The PPG sensor system consists of a light
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`source(s) and a detector(s). PPG sensor(s) monitor changes in the light intensity of
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`light reflected from or transmitted through the tissue. The changes in light
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`intensity are associated with small variations in blood perfusion of the tissue,
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`caused by cardiac contractions, and provide information on the cardiovascular
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`system.
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`41. PPG monitoring is reliable in measurements of oxygen saturation and
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`average heart rate, but historically has been found to be less reliable in detecting
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`arrhythmias, especially atrial arrhythmias. Compared to the traditional ECG data,
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`heart rate estimation is more challenging based on the PPG-signal.
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`See Ex. 2002.
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`42. As shown in the image above, motion artifacts, which are caused by
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`the user’s physical activity (e.g. arm movement), can create noisy signals resulting
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`in significantly reduced PPG-signal quality. Ex. 2002 at Figure 5. As a result, it is
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`difficult to obtain a clean signal and extract HR from contaminated PPG.
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`Therefore, increasing the accuracy and robustness of PPG-based heart rate
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`estimation remains at the forefront of research and development in this area even
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`to this day. See Ex 2003.
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`43. The ‘941 Patent explains the state of the art in arrhythmia detection,
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`the limitations in known techniques and equipment, and the need for the
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`inventors’ improvement in detection techniques and equipment. Ex. 1001 at 1:17-
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`2:9, 3:63-4:33.
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`V. THE ‘941 PATENT
`44. The ’941 patent teaches systems and methods that allow for the
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`convenient sensing of the presence of an intermittent arrhythmia in an individual.
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`Ex. 1001 at 1:26-2:3, 3:59-62.
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`45. The ’941 patent generally relates to the method and devices AliveCor
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`invented that enabled a user to wear a smartwatch equipped with sensors that
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`would monitor a user’s heart, activity, and allow the user to record an ECG. See,
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`e.g. id. at 2:10-3:12, 5:33-51, 8:1-26, 9:52-10:38; 11:8-59; 12:41-65; 14:48-15:59.
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`The ’941 patent envisioned comparing the data from the sensors to determine that
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`a discordance was possibly occurring, and then to use the ECG sensor to confirm
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`the presence of that arrhythmia. Id. at 12:41-65, 14:48-15:59.
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`46. The ‘941 patent explains that convenient parameter values may be
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`continuously sensed, including heart rate and activity level. Id. at 1:58-61. The
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`‘941 patent then discloses how to analyze those continuously-monitored values to
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`determine the presence or future onset of an arrhythmia when there is discordance
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`between those values. Id. at 1:61-2:3; 14:48-16:67. The patent also discloses that
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`an ECG may subsequently be taken to confirm the presence or absence of an
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`arrhythmia. See id. at 15:22-43.
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`47. The claims of the ‘941 Patent recite specific and novel
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`implementations of apparatuses and methods used for detecting possible
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`intermittent arrhythmias that address the limitations in the prior art including the
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`requirement that the users be made aware of the potentially life-threatening
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`arrhythmia and have ready access to specialized diagnostic equipment in a clinical
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`setting.
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`48. The claimed inventions thus offer a uniquely convenient heart
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`monitoring apparatus and methods that leverages wearability, specialized sensors,
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`and machine learning to generate more accessible and effective detection of
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`potentially dangerous arrhythmia conditions.
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`VI. LEVEL OF ORDINARY SKILL IN THE ART
`49.
`I disagree with Apple and Dr. Chaitman’s assertion that a Person of
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`Ordinary Skill in the Art (“POSITA”) would only need “a combination of
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`Bachelor’s Degree (or a similar Master’s Degree, or higher degree) in an
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`academic area emphasizing health science, or a related field, and two or more
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`years of work experience with cardiac monitoring technologies (e.g., a
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`cardiologist).” Ex. 1003 at ¶ 10; see also Petition at 10.
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`50.
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`In my opinion, it is insufficient that a POSITA in the field of the ‘941
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`Patent be defined in the context of the general field of “health science.”
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`51. For example, the Summary of the Invention explains that the
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`invention includes “systems, devices, and methods for cardiac monitoring” and
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`the use of “portable computing devices” that are specifically configured to
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`“predict or identify the occurrence of arrhythmias.” Ex. 1001 at 1:26-33.
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`52. A POSITA would need to understand the specific aspects of the
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`design, configuration, and operation of these devices requires, which specialized
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`engineering skills that a cardiologist may or may not possess in his or her
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`background.
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`53. As a result, a degree in biomedical or electrical engineering (or an
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`equivalent), and/or extensive experience working with arrhythmia detection tools
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`would also be necessary.
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`54. Dr. Chaitman only states in his declaration that his background
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`includes a “Bachelor of Science” degree, without specifying the field. Ex. 1003 at
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`5. Dr. Chaitman’s described experience is also limited to “the use of the rest and
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`exercise ECG as a diagnostic instrument” and “matters related to ECG analysis
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`and the use of ECG analysis as a diagnostic and prognostic tool.” Id. at 5-6
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`(emphases added).
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`55. Dr. Chaitman does not state that he has any background involving the
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`specialized engineering skills necessary for the design, configuration, and
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`operation of portable computing devices that are the subject of the ‘941 patent.
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`56.
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`I believe that Dr. Chaitman’s limited experience in the relevant field
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`leads to several misplaced assumptions in his declaration concerning the
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`
`
`AliveCor Ex. 2001 - Page 19
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`
`
`
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`limitations of PPG signal processing technology, what a POSITA would
`
`understand to exist in the field prior to the filing of the ‘941 Patent, and the extent
`
`to which a POSITA would be motivated to combine the asserted prior art
`
`references without the use of hindsight derived from the disclosures of the ‘941
`
`Patent itself.
`
`VII. OVERVIEW OF THE PRIMARY ASSERTED PRIOR ART
`REFERENCES
`A.
`PCT Patent Publication WO2012/140559 (“Shmueli”)
`57. Shmueli is titled “Pulse Oximetry Measurement Triggering ECG
`
`Measurement.” Ex. 1004 at 1.
`
`58. The Abstract states the disclosed invention is a “method and a system
`
`for triggering the measurement of electrocardiogram (ECG) signal of a user” by
`
`“continuously measuring SpO2 at the wrist of the user, detecting an irregular heart
`
`condition from the SpO2 measurement, notifying the user to perform an ECG
`
`measurement, and initiating the ECG measurement at least partially at the wrist.”
`
`Ex. 1004 at 1.
`
`59. Shmueli explains that the problem it is seeking to solve is that the
`
`prior art “does not consider a requirement to enable a patient to perform ECG
`
`measurement as soon as an irregular heart activity develops and without requiring
`
`the ECG to be constantly wired to the patient.” Ex. 1004 at 9. Shmueli states that
`
`this problem is addressed “by providing a combined oximetry and
`
`
`
`AliveCor Ex. 2001 - Page 20
`
`
`
`
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`electrocardiogram measuring system and a method in which the oximetry
`
`measurement is performed continuously and/or repeatedly, and the ECG
`
`measurement is triggered upon detection of an intermittent irregular heart-related
`
`event.” Id.
`
`B. U.S. Patent Publication 2014/0275840 (“Osorio”)
`60. Osorio is titled “Pathological State Detection Using Dynamically
`
`Determined Body Data Variability Range Values.” The Abstract states that the
`
`invention disclosed is directed to detecting a “pathological body state of a patient”
`
`by determining when a body data variability value, or “BDV,” is outside of a
`
`“value range.” Ex. 1005 at Abstract.
`
`61. Osorio’s summary of the field of the invention specifies that it
`
`“relates to medical device systems and methods capable of detecting a
`
`pathological body state of a patient, which may include epileptic seizures, and
`
`responding to the same.” Ex. 1005 at [0002]. Osorio also repeatedly refers to the
`
`“pathological state” as an epileptic seizure (a neurological condition), not
`
`arrhythmia. Id. at [0037], [0045], [0046], [0056], [0058], [0066]-[0068], [0073],
`
`[0083], [0090], [0096].
`
`62. Osorio discloses a “medical device system 100” that includes “a
`
`medical device 200, activity sensor(s) 212, lead(s) 211 coupling the activity
`
`sensor(s) 212 to the medical device 200, body signal sensors 282 and body signal
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`
`
`AliveCor Ex. 2001 - Page 21
`
`
`
`
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`leads 281 coupling body signal sensors 282 to medical device 200.” Ex. 1005 at
`
`[0033].
`
`63. Osorio explains that the system “may be fully or partially implanted”
`
`in a patient. Id.
`
`64. A schematic representation of the “medical device system” is
`
`provided in Figure 1 (reproduced below) showing the kinetic sensor(s) and body
`
`signal sensor(s) attached by leads to the medical device that contains various
`
`modules and units:
`
`
`
`
`
`AliveCor Ex. 2001 - Page 22
`
`
`
`
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`C. Atrial Fibrillation Detection using a Smart Phone, Lee, et al.
`(“Lee-2013”)
`65. Lee-2013 describes the use of a smartphone application for recording
`
`“a pulsatile PPG signal from a fingertip using the built-in camera lens” of the
`
`smartphone. Ex. 1011 at 1, 4.
`
`66. Lee-2013 explains that the application involved in the study “does
`
`not involve a separate ECG sensor and instead employs built-in hardware.” Id. at
`
`4.
`
`D. U.S. Patent No. 7,894,888 (“Chan”)
`67. Chan describes the use of a three-lead electrocardiogram device that
`
`can record ECG data that can then be “recorded and transmitted to a personal and
`
`hospital computer.” Ex. 1048 at Abstract, 1:47-50
`
`VIII. A PERSON OF ORDINARY SKILL IN THE ART WOULD NOT
`COMBINE THE OSORIO AND SHMUELI REFERENCES
`A. Apple fails to show why a POSITA would select Shmueli and
`Osorio and combine them
`68. A POSITA reading Shmueli and Osorio would understand that the
`
`references are directed to different base level concepts, and neither reference
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`discloses arrhythmia detection.
`
`69.
`
` With respect to Shmueli, the reference does not once mention
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`arrhythmia, and is instead focused on methods and devices for detecting an
`
`undefined “irregular heart condition,” the meaning of which one can only
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`
`
`AliveCor Ex. 2001 - Page 23
`
`
`
`
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`speculate as numerous conditions can be considered heart irregularities: normal
`
`autonomic nervous system control, autonomic dysfunction, heart failure, ischemia,
`
`myocardial infarction, heart block, etc. There is no attempt by Shmueli to define
`
`“irregular heart condition” with any specificity in the reference, and I do not agree
`
`with Apple’s assumption that a POSITA would automatically assume that the
`
`term refers to arrhythmia in general, and to atrial fibrillation in particular.
`
`70. Osorio is directed to the use of a “body data variability” metric to
`
`inform the detection of a “pathological state”—which Osorio repeatedly makes
`
`clear refers to seizures. See Ex. 1005 at [0037], [0045], [0046], [0056], [0058],
`
`[0066]-[0068], [0073], [0083], [0090], [0096].
`
`71. A POSITA would therefore not look to either Shmueli or Osorio,
`
`alone or in combination, to solve the problem of detecting potential
`
`tachyarrhythmia using the combination of sensors disclosed in the ‘941 Patent.
`
`72. Shmueli is also entirely silent as to a user’s activity level and,
`
`therefore, does not disclose, at least, sensing an activity level of a user and
`
`determining a discordance between a user’s activity level and a heart rate
`
`parameter. Nor does Shmueli disclose determining heart rate variability.
`
`73. Apple’s argument that a POSITA would combine Shmueli with
`
`Osorio assumes that a POSITA would already know that activity measurements
`
`were required to avoid “false diagnoses” of arrhythmia, and then would
`
`
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`AliveCor Ex. 2001 - Page 24
`
`
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`
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`automatically look to Osorio for the necessary disclosures of activity level
`
`monitoring. However, the purpose of Osorio’s activity level monitoring is “to
`
`determine if and when a patient is in a seizure state that manifests with increases
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`in heart rate.” Ex. 1005 at [0029]. In my opinion, Apple fails to offer any
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`legitimate explanation as to why a POSITA would have selected Osorio, a
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`reference directed to the detection of a neurological condition like epileptic
`
`seizures, to be added to Shmueli, a reference directed to the detection of vague
`
`and undisclosed cardiac conditions without mentioning arrhythmia even once, in
`
`order to accurately detect arrhythmia.
`
`74.
`
`I also disagree with Apple’s assertion that combining Osorio with
`
`Shmueli would be “consistent with
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