IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Gopalakrishnan
`In re Patent of:
`U.S. Patent No.:
`10,595,731
`March 24, 2020
`Issue Date:
`Appl. Serial No.: 16/588,201
`Filing Date:
`September 30, 2019
`Title:
`METHODS AND SYSTEMS FOR ARRHYTHMIA TRACKING
`AND SCORING
`
` Attorney Docket No.: 50095-0033IP1
`
`DECLARATION OF DR. BERNARD R. CHAITMAN
`
`1
`
`APPLE 1003
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`

`

`Table of Contents
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`ASSIGNMENT .............................................................................................................................................. 6
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`QUALIFICATIONS ...................................................................................................................................... 6
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`SUMMARY OF CONCLUSIONS FORMED ............................................................................................ 8
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`BACKGROUND KNOWLEDGE ONE OF SKILL IN THE ART WOULD HAVE HAD PRIOR TO
`
`THE PRIORITY DATE OF THE ’731 PATENT ...................................................................................... 9
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`
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`LEGAL PRINCIPLES ................................................................................................................................ 10
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`A.
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`B.
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`C.
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`D.
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`A.
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`B.
`
`C.
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`D.
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`E.
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`F.
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`CLAIM CONSTRUCTION ............................................................................................................................... 11
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`PRIORITY .................................................................................................................................................... 11
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`ANTICIPATION ............................................................................................................................................ 11
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`OBVIOUSNESS ............................................................................................................................................. 12
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`MATERIALS CONSIDERED ................................................................................................................... 14
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`TECHNOLOGY OVERVIEW .................................................................................................................. 21
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`ARRHYTHMIA ............................................................................................................................................. 21
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`ELECTROCARDIOGRAPHY (ECG) ................................................................................................................ 23
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`PHOTOPLETHYSMOGRAPHY (PPG) ............................................................................................................. 24
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`HEART RATE (HR) ..................................................................................................................................... 25
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`HEART RATE VARIABILITY (HRV) ............................................................................................................. 26
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`MACHINE LEARNING ALGORITHMS ............................................................................................................ 27
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` OVERVIEW OF THE ’731 PATENT ....................................................................................................... 28
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`
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`OVERVIEW OF THE PROSECUTION HISTORY ............................................................................... 30
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`SUMMARY OF THE PRIOR ART .......................................................................................................... 32
`
`A.
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`SHMUELI ..................................................................................................................................................... 32
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`2
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`

`

`B.
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`C.
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`D.
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`E.
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`OSORIO ....................................................................................................................................................... 37
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`LI 2012 OVERVIEW ..................................................................................................................................... 42
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`KLEIGER 2005 OVERVIEW .......................................................................................................................... 43
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`CHAN OVERVIEW ....................................................................................................................................... 47
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`
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`ANALYSIS OF SHMUELI ........................................................................................................................ 49
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
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`H.
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`I.
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`J.
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`K.
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`CLAIM 1 ...................................................................................................................................................... 49
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`CLAIM 7 ...................................................................................................................................................... 79
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`CLAIM 12 .................................................................................................................................................... 82
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`CLAIM 13 .................................................................................................................................................... 85
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`CLAIM 16 .................................................................................................................................................... 87
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`CLAIM 17 .................................................................................................................................................... 89
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`CLAIM 23 .................................................................................................................................................... 90
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`CLAIM 24 .................................................................................................................................................... 90
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`CLAIM 25 .................................................................................................................................................... 90
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`CLAIM 26 .................................................................................................................................................... 94
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`CLAIM 30 .................................................................................................................................................... 94
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`
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`ANALYSIS OF SHMUELI IN VIEW OF OSORIO ................................................................................ 95
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`I.
`
`J.
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`THE COMBINATION OF SHMUELI AND OSORIO ........................................................................................... 95
`
`CLAIM 1 .................................................................................................................................................... 108
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`CLAIM 2 .................................................................................................................................................... 116
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`CLAIM 4 .................................................................................................................................................... 120
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`CLAIM 7 .................................................................................................................................................... 130
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`CLAIM 12 .................................................................................................................................................. 131
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`CLAIM 13 .................................................................................................................................................. 133
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`CLAIM 14 .................................................................................................................................................. 134
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`CLAIM 16 .................................................................................................................................................. 136
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`CLAIM 17 .................................................................................................................................................. 137
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`3
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`

`

`K.
`
`L.
`
`M.
`
`N.
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`O.
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`P.
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`Q.
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`CLAIM 18 .................................................................................................................................................. 137
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`CLAIM 20 .................................................................................................................................................. 138
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`CLAIM 23 .................................................................................................................................................. 138
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`CLAIM 24 .................................................................................................................................................. 138
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`CLAIM 25 .................................................................................................................................................. 138
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`CLAIM 26 .................................................................................................................................................. 140
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`CLAIM 30 .................................................................................................................................................. 140
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` ANALYSIS OF SHMUELI IN VIEW OF OSORIO AND LI 2012 ...................................................... 140
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
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`THE COMBINATION OF SHMUELI, OSORIO AND LI 2012 ........................................................................... 141
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`CLAIM 3 .................................................................................................................................................... 144
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`CLAIM 5 .................................................................................................................................................... 145
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`CLAIM 6 .................................................................................................................................................... 147
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`CLAIM 19 .................................................................................................................................................. 149
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`CLAIM 21 .................................................................................................................................................. 149
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`CLAIM 22 .................................................................................................................................................. 149
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` ANALYSIS OF SHMUELI IN VIEW OF OSORIO AND KLEIGER 2005 ........................................ 149
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
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`THE COMBINATION OF SHMUELI, OSORIO AND KLEIGER 2005 ................................................................. 150
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`CLAIM 8 .................................................................................................................................................... 151
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`CLAIM 9 .................................................................................................................................................... 152
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`CLAIM 10 .................................................................................................................................................. 153
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`CLAIM 11 .................................................................................................................................................. 154
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`CLAIM 27 .................................................................................................................................................. 155
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`CLAIM 28 .................................................................................................................................................. 155
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`CLAIM 29 .................................................................................................................................................. 155
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`
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`ANALYSIS OF SHMUELI (OR SHMUELI AND OSORIO) IN VIEW OF CHAN .......................... 155
`
`A.
`
`B.
`
`THE COMBINATION OF SHMUELI (OR SHMUELI AND OSORIO) AND CHAN ................................................ 156
`
`CLAIM 15 .................................................................................................................................................. 161
`
`4
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`

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`XVI.
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` CONCLUSION .......................................................................................................................................... 163
`CONCLUSION .......................................................................................................................................... 163
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`5
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`

`

`I, Dr. Bernard R. Chaitman, of St. Louis, Missouri, declare that:
`
`
`1.
`
`ASSIGNMENT
`I have been retained on behalf of Apple Inc. (“Apple” or “Petitioner”)
`
`to offer technical opinions related to U.S. Patent No. 10,595,731 (“The ’731
`
`patent”) (APPLE-1001). I understand that Apple is requesting that the Patent Trial
`
`and Appeal Board (“PTAB” or “Board”) to institute an inter partes review (“IPR”)
`
`proceeding of the ’731 patent.
`
`2.
`
`I have been asked to provide my independent analysis of the ’731
`
`patent in light of the prior art publications cited in this declaration.
`
`3.
`
`I am not and never have been, an employee of Apple. I received no
`
`compensation for this declaration beyond my normal hourly compensation based
`
`on my time actually spent analyzing the ’731 patent, the prior art publications cited
`
`below, and issues related thereto, and I will not receive any added compensation
`
`based on the outcome of any IPR or other proceeding involving the ’731 patent
`
` QUALIFICATIONS
`I am over the age of 18 and am competent to write this declaration. I
`
`4.
`
`have personal knowledge, or have developed knowledge of these technologies
`
`based upon education, training, or experience, of the matters set forth herein.
`
`5.
`
`I am an Emeritus Professor of Medicine, and Director of
`
`Cardiovascular Research at St Louis University School of Medicine. I am also a
`
`6
`
`

`

`Board-Certified Cardiologist and have practiced Internal Medicine and
`
`Cardiovascular Disease for four decades. I am currently licensed in the State of
`
`Missouri and Florida. I also serve as the Chair for Clinical Event Committees and
`
`Data and Safety Monitoring Boards for numerous clinical trials sponsored by
`
`National Heart Lung and Blood Institute (NHLBI) and industry. I am currently a
`
`member of the Editorial Board of nine journals that include Circulation, Journal of
`
`the American College of Cardiology, and the European Heart Journal. I also
`
`founded and am the Medical Director of St Louis University Core ECG Laboratory
`
`that provides ECG analysis for numerous NHLBI and industry sponsored clinical
`
`trials that test various treatment strategies.
`
`6.
`
`I received a Bachelor of Science degree in 1965 and a medical degree
`
`1969, both from McGill University in Montreal, Canada. I completed my Internal
`
`Medicine training at McGill University and Royal Victoria Hospital in 1972. I then
`
`completed post-graduate training in Cardiovascular Diseases at the University of
`
`Oregon (from 1972-1974) and University of Montreal (from 1974-1975).
`
`7.
`
`I have a long and distinguished career in academic medicine and have
`
`published more than 400 peer-reviewed papers and more than 600 abstracts, book
`
`chapters, and short communications. My areas of expertise in Cardiovascular
`
`Medicine include rest and exercise ECG analysis, diagnostic noninvasive testing,
`
`large scale multinational clinical trials testing different treatment strategies, and
`
`7
`
`

`

`drug development. I have received funding from the National Heart Lung and
`
`Blood Institute (NHLBI) for more than 3 decades and also funding by the
`
`Department of Defense. My experience is recognized internationally and I have
`
`lectured abroad and published frequently with cardiologists in Europe.
`
`8.
`
`I have served as a consultant to the Food and Drug Administration on
`
`ECG related issues, and the use of the rest and exercise ECG as a diagnostic
`
`instrument. I also served as a committee member for the American Heart
`
`Association, American College of Cardiology, and the European Society of
`
`Cardiology in matters related to ECG analysis and the use of ECG analysis as a
`
`diagnostic and prognostic tool. I served on grant review committees for the
`
`NHLBI, the Veterans Administration Review Board, and the American Heart
`
`Association.
`
` SUMMARY OF CONCLUSIONS FORMED
`This Declaration explains the conclusions that I have formed based on
`
`9.
`
`my analysis. To summarize those conclusions:
`
`
`
`Ground 1: Based upon my knowledge and experience and my review of the
`
`prior art publications in this declaration, I believe that claims 1, 7, 12, 13,
`
`16, 17, 23-26 and 30 of the ’731 patent are rendered obvious by Shmueli.
`
`
`
`Ground 2: Based upon my knowledge and experience and my review of the
`
`prior art publications in this declaration, I believe that claims 1, 2, 4, 7, 12-
`
`8
`
`

`

`14, 16-18, 20, 23-26 and 30 of the ’731 patent are rendered obvious by
`
`Shmueli in view of Osorio.
`
`
`
`Ground 3: Based upon my knowledge and experience and my review of the
`
`prior art publications in this declaration, I believe that claims 13, 5, 6, 19, 21
`
`and 22 of the ’731 patent are rendered obvious by Shmueli in view of Osorio
`
`and Li 2012.
`
`
`
`Ground 4: Based upon my knowledge and experience and my review of the
`
`prior art publications in this declaration, I believe that claims 8-11 and 27-29
`
` of the ’731 patent are rendered obvious by Shmueli in view of Osorio and
`
`Kleiger 2005.
`
`
`
`Ground 5: Based upon my knowledge and experience and my review of the
`
`prior art publications in this declaration, I believe that claim 15 of the ’731
`
`patent is rendered obvious by Shmueli in view of Osorio and Chan.
`
` BACKGROUND KNOWLEDGE ONE OF SKILL IN THE ART
`WOULD HAVE HAD PRIOR TO THE PRIORITY DATE OF THE ’731
`PATENT
`10.
`
`I have been informed that a person of ordinary skill in the art is a
`
`hypothetical person who is presumed to have the skill and experience of an
`
`ordinary worker in the field at the time of the alleged invention. Based on my
`
`knowledge and experience in the field and my review of the ’731 patent and file
`
`history, I believe that a person of ordinary skill in the art in this matter would have
`
`9
`
`

`

`had at least a combination of Bachelor’s Degree (or a similar Master’s Degree, or
`
`higher degree) in an academic area emphasizing health science, or a related field,
`
`and two or more years of work experience with cardiac monitoring technologies
`
`(e.g., as a cardiologist). Additional education or industry experience may
`
`compensate for a deficit in one of the other aspects of the requirements stated
`
`above.
`
`11. My analysis and conclusions set forth in this declaration are based on
`
`the perspective of a person of ordinary skill in the art having this level of
`
`knowledge and skill as of the date of the alleged invention of the ’731 patent
`
`(“POSITA”). Based on instruction from Counsel, I have applied March 14, 2014
`
`(“Critical Date”), as the date of the alleged invention of the ’731 patent. However,
`
`my analysis of the prior art and the conclusions I have formed as set forth herein
`
`would also apply even if the date of the alleged invention as claimed was
`
`December 12, 2013 (“earliest possible effective filing date”).
`
`12. Based on my experiences, I have a good understanding of the
`
`capabilities of a POSITA. Indeed, I have taught, mentored, advised, and
`
`collaborated closely with many such individuals over the course of my career.
`
` LEGAL PRINCIPLES
`13.
`I am not a lawyer and I will not provide any legal opinions in this IPR.
`
`Although I am not a lawyer, I have been advised that certain legal standards are to
`
`10
`
`

`

`be applied by technical experts in forming opinions regarding the meaning and
`
`validity of patent claims.
`
`A. Claim construction
`I understand that claim terms are generally given their plain and
`
`14.
`
`ordinary meaning in light of the patent’s specification and file history as
`
`understood by a person of ordinary skill in the art at the time of the purported
`
`invention. In that regard, I understand that the best indicator of claim meaning is its
`
`usage in the context of the patent specification as understood by a POSITA. I
`
`further understand that the words of the claims should be given their plain meaning
`
`unless that meaning is inconsistent with the patent specification or the patent’s
`
`history of examination before the Patent Office. I also understand that the words
`
`of the claims should be interpreted as they would have been interpreted by a
`
`POSITA at the time of the invention was made (not today).
`
`B.
`Priority
`I understand that a continuation application is a later-filed application
`
`15.
`
`that has the same disclosure (specification and figures) as an earlier filed
`
`application to which the later-filed application claims priority. A continuation is
`
`generally entitled to the same priority date as the later-filed application to which it
`
`claims priority.
`
`C. Anticipation
`I understand that a patent claim is invalid as anticipated if each and
`
`16.
`
`11
`
`

`

`every element as set forth in the claim is found, either expressly or inherently
`
`described, in a single prior art reference. I also understand that, to anticipate, the
`
`reference must teach all of the limitations arranged or combined in the same way
`
`as recited in the claim. I do not rely on anticipation in this declaration.
`
`17. With respect to inherency, I understand that the fact that a certain
`
`result or characteristic may occur or be present in the prior art is not sufficient to
`
`establish the inherency of that result or characteristic. Instead, the inherent
`
`characteristic must necessarily flow from the teaching of the prior art.
`
`D. Obviousness
`I understand that a patent claim is invalid if the claimed invention
`
`18.
`
`would have been obvious to a person of ordinary skill in the field at the time of the
`
`purported invention, which is often considered the time the application was filed.
`
`Thus, even if all of the claim limitations are not found in a single prior art
`
`reference that anticipates the claim, the claim can still be invalid.
`
`19. To obtain a patent, a claimed invention must have, as of the priority
`
`date, been nonobvious in view of the prior art in the field. I understand that an
`
`invention is obvious when the differences between the subject matter sought to be
`
`patented and the prior art are such that the subject matter as a whole would have
`
`been obvious at the time the invention was made to a person having ordinary skill
`
`in the art.
`
`12
`
`

`

`20.
`
`I understand that, to prove that prior art or a combination of prior art
`
`renders a patent obvious it is necessary to: (1) identify the particular references
`
`that, singly or in combination, make the patent obvious; (2) specifically identify
`
`which elements of the patent claim appear in each of the asserted references; and
`
`(3) explain a motivation, teaching, need, market pressure or other legitimate reason
`
`that would have inspired a person of ordinary skill in the art to combine prior art
`
`references to solve a problem.
`
`21.
`
`I also understand that certain objective indicia can be important
`
`evidence regarding whether a patent is obvious or nonobvious. Such indicia
`
`include:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Commercial success of products covered by the patent claims;
`
`A long-felt need for the invention;
`
`Failed attempts by others to make the invention;
`
`Copying of the invention by others in the field;
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`Unexpected results achieved by the invention as compared to the closest
`
`prior art;
`
`Praise of the invention by the infringer or others in the field;
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`The taking of licenses under the patent by others;
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`Expressions of surprise by experts and those skilled in the art at the making
`
`of the invention; and
`
`13
`
`

`

`
`
`The patentee proceeded contrary to the accepted wisdom of the prior art.
`
`22. To the extent these factors have been brought to my attention, if at all,
`
`I have taken them into consideration in rendering my opinions and conclusions.
`
` MATERIALS CONSIDERED
`23. My analysis and conclusions set forth in this declaration are based on
`
`my educational background and experiences in the field (see Section IV). Based on
`
`my above-described experience, I believe that I am considered to be an expert in
`
`the field. Also, based on my experiences, I understand and know of the capabilities
`
`of persons of ordinary skill in the field during the early 1990s–2010s, and I taught,
`
`participated in organizations, and worked closely with many such persons in the
`
`field during that time frame.
`
`24. As part of my independent analysis for this declaration, I have
`
`considered the following: the background knowledge/technologies that were
`
`commonly known to persons of ordinary skill in this art during the time before the
`
`earliest claimed priority date for the ’731 patent; my own knowledge and
`
`experiences gained from my work experience in the field of the ’731 patent and
`
`related disciplines; and my experience in working with others involved in this field
`
`and related disciplines.
`
`25.
`
`In addition, I have analyzed the following publications and materials:
`
` U.S. Pat. No. 10,595,731 to Gopalakrishnan (“the ’731 patent”) (APPLE-
`
`14
`
`

`

`1001)
`
` Excerpts from the Prosecution History of the ’731 patent (“the Prosecution
`
`History”) (APPLE-1002)
`
` PCT Patent Publication WO2012/140559 (“Shmueli”) (APPLE-1004)
`
` U.S. Patent Publication 2014/0275840 (“Osorio”) (APPLE-1005)
`
` Li Q, Clifford GD, “Signal quality and data fusion for false alarm reduction
`
`in the intensive care unit,” J Electrocardiol. 2012 Nov-Dec; 45(6):596-603
`
`(“Li 2012”) (APPLE-1006)
`
` U.S. Patent Publication 2008/0004904 (“Tran”) (APPLE-1007)
`
` U.S. Patent Publication 2014/0107493 (“Yuen”) (APPLE-1008)
`
` U.S. Patent Publication 2015/0119725 (“Martin”) (APPLE-1009)
`
` U.S. Provisional Application No. 61/794,540 (“Osorio Provisional”)
`
`(APPLE-1010)
`
` Lee J, Reyes BA, McManus DD, Mathias O, Chon KH. Atrial fibrillation
`
`detection using a smart phone. Annu Int Conf IEEE Eng Med Biol Soc.
`
`2012; 2012:1177-800 (“Lee 2013”) (APPLE-1011)
`
` Tsipouras MG, Fotiadis DI. Automatic arrhythmia detection based on time
`
`and time-frequency analysis of heart rate variability. Comput Methods
`
`Programs Biomed. 2004 May; 74(2):95-108 (“Tsipouras 2004”) (APPLE-
`
`1012)
`
`15
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`

`

` Lu S, Zhao H, Ju K, Shin K, Lee M, Shelley K, Chon KH. Can
`
`photoplethysmography variability serve as an alternative approach to obtain
`
`heart rate variability information? J Clin Monit Comput. 2008 Feb; 22(1):23-
`
`9 (“Lu 2008”) (APPLE-1013)
`
` Selvaraj N, Jaryal A, Santhosh J, Deepak KK, Anand S. Assessment of heart
`
`rate variability derived from finger-tip photoplethysmography as compared
`
`to electrocardiography. J Med Eng Technol. 2008 Nov-Dec; 32(6):479-84
`
`(“Selvaraj 2008”) (APPLE-1014)
`
` Lu G, Yang F, Taylor JA, Stein JF. A comparison of photoplethysmography
`
`and ECG recording to analyse heart rate variability in healthy subjects. J
`
`Med Eng Technol. 2009; 33(8):634-41 (“Lu 2009”) (APPLE-1015)
`
` Suzuki T, Kameyama K, Tamura T. Development of the irregular pulse
`
`detection method in daily life using wearable photoplethysmographic sensor.
`
`Annu Int Conf IEEE Eng Med Biol Soc. 2009; 2009:6080-3 (“Suzuki
`
`2009”) (APPLE-1016)
`
` Reed MJ, Robertson CE, Addison PS. Heart rate variability measurements
`
`and the prediction of ventricular arrhythmias. QJM. 2005 Feb; 98(2):87-95
`
`(“Reed 2005”) (APPLE-1017)
`
` Schäfer A, Vagedes J. How accurate is pulse rate variability as an estimate
`
`of heart rate variability? A review on studies comparing
`
`16
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`

`

`photoplethysmographic technology with an electrocardiogram. Int J Cardiol.
`
`2013 Jun 5; 166(1):15-29 (“Schafer 2013”) (APPLE-1018)
`
` K. Douglas Wilkinson, “The Clinical Use of the Sphygmomanometer,” The
`
`British Medical Journal, 1189-90 (Dec. 27, 1924) (“Wilkinson”) (APPLE-
`
`1019)
`
` U.S. Pat. No. 6,095,984 (“Amano”) (APPLE-1020)
`
` B.K. Bootsma et. al, “Analysis of R-R intervals with atrial fibrillation at rest
`
`and during exercise.” Circulation 1970; 41:783-794 (APPLE-1021)
`
` Frits L. Meijler and Fred H. M. Wittkampf, “Role of the Atrioventricular
`
`Node in Atrial Fibrillation” Atrial Fibrillation: Mechanisms and
`
`Management, 2nd ed. 1997 (“Meijler”) (APPLE-1022)
`
` Heart Diseases _ Definition of Heart Diseases by Merriam-Webster
`
`(APPLE-1023)
`
` Rajendra Acharya U, Paul Joseph K, Kannathal N, Lim CM, Suri JS. Heart
`
`rate variability: a review. Med Biol Eng Comput. 2006 Dec; 44(12):1031-51
`
`(“Acharya 2006”) (APPLE-1024)
`
` Saime Akdemir Akar, Sadık Kara, Fatma Latifoğlu, Vedat Bilgiç. Spectral
`
`analysis of photoplethysmographic signals: The importance of
`
`preprocessing. Biomedical Signal Processing and Control, 2013; 8(1):16-22
`
`(Akar 2013) (APPLE-1025)
`
`17
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`

`

` U.S. Provisional Application No. 61/915,113 (APPLE-1026)
`
` U.S. Provisional Application No. 61/953,616 (APPLE-1027)
`
` U.S. Provisional Application No. 61/969,019 (APPLE-1028)
`
` U.S. Provisional Application No. 61/970,551 (APPLE-1029)
`
` U.S. Provisional Application No. 62/014516 (APPLE-1030)
`
` U.S. Patent Publication No. 2012/0203491 (“Sun”) (APPLE-1031)
`
` U.S. Patent No. 9,808,206 (“Zhao”) (APPLE-1032)
`
` Kleiger RE, Stein PK, Bigger JT Jr. Heart rate variability: measurement and
`
`clinical utility. Ann Noninvasive Electrocardiol. 2005 Jan; 10(1):88-101
`
`(“Kleiger 2005”) (APPLE-1033)
`
` Chen Z, Brown EN, Barbieri R. Characterizing nonlinear heartbeat
`
`dynamics within a point process framework. IEEE Trans Biomed Eng. 2010
`
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