UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`VIEWRAY, INC. and VIEWRAY TECHNOLOGIES, INC.
`Petitioner,
`
`v.
`
`VARIAN MEDICAL SYSTEMS, INC.,
`Patent Owner
`
`Case No.: IPR2020-01465
`U.S. Patent No. 8,637,841 B2
`Title: MULTI LEVEL MULTILEAF COLLIMATORS
`
`DECLARATION OF NIKO PAPANIKOLAOU
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,637,841 B2
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`ViewRay Exhibit 1003
`Page 1 of 184
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`

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`DECLARATION OF NIKO PAPANIKOLAOU, PH.D.
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,637,841 B2
`
` hereby declare that all the statements made in this Declaration are of my
`
` I
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`own knowledge and true; that all statements made on information and belief are
`
`believed to be true; and further that these statements were made with the
`
`knowledge that willful false statements and the like so made are punishable by fine
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`or imprisonment, or both, under 18 U.S.C. § 1001 and that such willful false
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`statements may jeopardize the validity of the application or any patent issued
`
`thereon.
`
`I declare under the penalty of perjury that all statements made in this
`
`Declaration are true and correct.
`
`Executed August 12, 2020 in San Antonio, Texas.
`
`
`Niko Papanikolaou, Ph.D.
`
`
`
`
`
`
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`ViewRay Exhibit 1003
`Page 2 of 184
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`
`
`TABLE OF CONTENTS
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`Page
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`III. 
`
`IV. 
`
`LIST OF APPENDICES ................................................................................................................ iv 
`I. 
`INTRODUCTION .............................................................................................................. 1 
`II. 
`OVERVIEW ....................................................................................................................... 3 
`A. 
`QUALIFICATIONS AND EXPERIENCE ............................................................ 3 
`1. 
`Education and Work Experience ................................................................ 3 
`2. 
`Compensation ............................................................................................. 8 
`3. 
`Documents and Other Materials Relied Upon ............................................ 8 
`STATEMENT OF LEGAL PRINCIPLES ......................................................................... 9 
`A. 
`Claim Construction ................................................................................................. 9 
`B. 
`Anticipation............................................................................................................. 9 
`C. 
`Obviousness .......................................................................................................... 10 
`BACKGROUND OF THE TECHNOLOGY ................................................................... 12 
`A. 
`Radiation therapy and beam collimation .............................................................. 12 
`B. 
`Multi-layer MLCs ................................................................................................. 15 
`C. 
`Focusing for improved penumbra ......................................................................... 17 
`1. 
`Focusing leaf ends – arc leaf movement ................................................... 17 
`2. 
`Focusing leaf sides – trapezoidal cross-sections ....................................... 20 
`3. 
`Focusing in a multi-level MLC – projected widths .................................. 23 
`OVERVIEW OF THE ‘841 PATENT .............................................................................. 27 
`A. 
`Summary of the patent .......................................................................................... 27 
`B. 
`Prosecution history of the patent ........................................................................... 29 
`C. 
`Priority date ........................................................................................................... 29 
`D. 
`Level of ordinary skill in the art ........................................................................... 29 
`E. 
`Claim construction ................................................................................................ 30 
`“each of the first and second sets includes an inner first section of a
`1. 
`plurality of pairs of leaves having a first cross section and an outer
`second section of a plurality of pairs of leaves having a second
`cross section” (appears in claim 1) ........................................................... 31 
`wherein the second section in each of the first and second sets
`includes a plurality of pairs of leaves at each side of the inner first
`section (appears in claim 1) ...................................................................... 33 
`i
`
`V. 
`
`2. 
`
`
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`ViewRay Exhibit 1003
`Page 3 of 184
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`3. 
`
`VI. 
`
`a pair of leaves in the first set close at a first location, a
`corresponding pair of leaves in the second set close at a second
`location, and the first and second locations are offset from a beam's
`point of view (appears in claim 20) .......................................................... 35 
`UNPATENTABILITY OF CHALLENGED CLAIMS ................................................... 36 
`A. 
`The cited references are prior art .......................................................................... 36 
`B. 
`Summary of opinions and grounds for invalidity ................................................. 36 
`C. 
`Ground 1: Claim 20 is unpatentable under 35 U.S.C. § 103 as obvious
`over Yamazaki (Ex. 1027) .................................................................................... 37 
`Claim 20: A method of shaping radiation beams from a radiation
`1. 
`source, comprising: ................................................................................... 41 
`Ground 2: Claims 21-22 are unpatentable under 35 U.S.C. § 103 as
`obvious over Yamazaki (Ex. 1027) alone or in view of Cosgrove (Ex.
`1024) ..................................................................................................................... 46 
`Claim 21: The method of claim 20 wherein at the first location, the
`1. 
`pair of leaves in the first set are in contact. ............................................... 46 
`Claim 22: The method of claim 21 wherein at the second location,
`the pair of leaves in the second set are in contact. .................................... 49 
`Ground 3: Claims 1-4 are unpatentable under 35 U.S.C. § 103 as obvious
`over Wallace (Ex. 1013) alone or in view of Schlegel (Ex. 1011), Klassen
`(Ex. 1008) and Vilsmeier (Ex. 1028) .................................................................... 49 
`1. 
`Claim 1: A multileaf collimator comprising: ............................................ 56 
`2. 
`Claim 2: The multileaf collimator of claim 1 wherein the second
`cross section of the leaves in the second section of the first set is
`thinner than the second cross section of the leaves in the second
`section of the second set ........................................................................... 66 
`Claim 3: The multileaf collimator of claim 1 wherein the first cross
`section of the plurality of leaves in the first section of the first set is
`thinner than the second cross section of the plurality of leaves in
`the second section of the first set, and/or the first cross section of
`the plurality of leaves in the first section of the second set is
`thinner than the second cross section of the plurality of leaves in
`the second section of the second set ......................................................... 67 
`Claim 4: The multileaf collimator of claim 3 wherein the leaves in
`each of the second sections of the first and second sets are
`symmetrically disposed relative to each of the first sections of the
`first and second sets respectively .............................................................. 68 
`
`D. 
`
`E. 
`
`2. 
`
`3. 
`
`4. 
`
`ii
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`Page 4 of 184
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`F. 
`
`G. 
`
`Ground 4: Claims 1-2 are unpatentable under 35 U.S.C. § 103 as obvious
`over Noguchi (Ex. 1014) alone or in view of Schlegel (Ex. 1011), Klassen
`(Ex. 1008) and Cui (Ex. 1025) .............................................................................. 70 
`1. 
`Claim 1: A multileaf collimator comprising: ............................................ 74 
`2. 
`Claim 2: The multileaf collimator of claim 1 wherein the second
`cross section of the leaves in the second section of the first set is
`thinner than the second cross section of the leaves in the second
`section of the second set ........................................................................... 88 
`Ground 5: Claims 3-4 are unpatentable under 35 U.S.C. § 103 as obvious
`over Noguchi (Ex. 1014) in view of Schlegel (Ex. 1011), Klassen (Ex.
`1008) and Cui (Ex. 1025)...................................................................................... 88 
`Claim 3: The multileaf collimator of claim 1 wherein the first cross
`1. 
`section of the plurality of leaves in the first section of the first set is
`thinner than the second cross section of the plurality of leaves in
`the second section of the first set, and/or the first cross section of
`the plurality of leaves in the first section of the second set is
`thinner than the second cross section of the plurality of leaves in
`the second section of the second set ......................................................... 88 
`Claim 4: The multileaf collimator of claim 3 wherein the leaves in
`each of the second sections of the first and second sets are
`symmetrically disposed relative to each of the first sections of the
`first and second sets respectively .............................................................. 90 
`VII.  CONCLUSION ................................................................................................................. 92 
`
`
`2. 
`
`
`
`iii
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`ViewRay Exhibit 1003
`Page 5 of 184
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`DECLARATION OF NIKO PAPANIKOLAOU, PH.D.
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,637,841 B2
`LIST OF APPENDICES
`
`Appendix A
`
`Curriculum Vitae of Niko Papanikolaou
`
`
`
`iv
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`ViewRay Exhibit 1003
`Page 6 of 184
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`DECLARATION OF NIKO PAPANIKOLAOU, PH.D.
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,637,841 B2
`
`INTRODUCTION
`My name is Niko Papanikolaou, and I am a Professor and Chief of the
`
`I.
`1.
`
`Division of Medical Physics at the University of Texas Health Science Center at
`
`San Antonio in the Department of Radiation Oncology and Radiology. I am a
`
`medical physicist specializing in radiation oncology. I hold a license to practice in
`
`Texas and I am certified by the American Board of Radiology (ABR) in
`
`therapeutic medical physics. I serve as a reviewer for several medical journals as
`
`well as on review panels for the American Association of Physicists in Medicine
`
`(AAPM) and the American Association of Radiation Oncology Biology and
`
`Physics (ASTRO) annual meetings. I am over 21 years of age and otherwise
`
`competent to make this Declaration. I make this Declaration based on facts and
`
`matters within my own knowledge and on information provided to me by others,
`
`and, if called as a witness, I could and would competently testify to the matters set
`
`forth herein.
`
`2.
`
`I have been engaged by VIEWRAY, INC. and VIEWRAY
`
`TECHNOLOGIES, INC. (“Petitioner”) to investigate and opine on certain issues
`
`relating to U.S. Patent No. 8,637,841 B2 entitled “MULTI LEVEL MULTILEAF
`
`COLLIMATORS” (‘841 Patent”) (Ex. 1001).
`
`1
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`
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`Page 7 of 184
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`3.
`
`I understand that the ‘841 Patent was assigned to VARIAN
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`MEDICAL SYSTEMS, Inc. (“Varian”). Varian is also referred to as the “Patent
`
`Owner” in this document.
`
`4.
`
`In this declaration, I will discuss the technology related to the ‘841
`
`Patent, including an overview of that technology as it was known at the time the
`
`patent was filed and as of the earliest claimed priority date, which according to
`
`Petitioner’s counsel is August 23, 2010, the filing date of its application. This
`
`overview of the technology provides some of the bases for my opinions with
`
`respect to the ‘841 Patent.
`
`5.
`
`This declaration is based on the information currently available to me.
`
`To the extent that additional information becomes available, I reserve the right to
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`continue my investigation and study and provide updated opinions as appropriate.
`
`6.
`
`In forming my opinions, I have relied on information and evidence
`
`identified in this declaration, including without limitation the ‘841 Patent, the
`
`prosecution history of the ‘841 Patent, and prior art including Yamazaki (Ex.
`
`1027), Cosgrove (Ex. 1024), Wallace (Ex. 1013), Schlegel (Ex. 1011), Klassen
`
`(Ex. 1008), Vilsmeier (Ex. 1028), Cui (Ex. 1025), and other items discussed below.
`
`I have also relied on my own experience and expertise in the technologies and
`
`systems that were already in use prior to, and within, the timeframe of the earliest
`
`2
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`claimed priority date of the claimed subject matter in the ‘841 Patent – August 23,
`
`2010.
`
`II.
`7.
`
`OVERVIEW
`The challenged claims 1-4 and 20-22 of the ‘841 Patent generally
`
`describe particular arrangements of pairs of beam blocking leaves in a multilevel
`
`multileaf collimator (“MLC”). See, e.g., Exhibit 1001 (‘841 Patent) at Abstract. In
`
`its simplest form, an MLC consists of two opposed banks of leaves, with each leaf
`
`capable of individually moving in and out of the radiation field to shape the beam
`
`to match a tumor. See, id. at Fig. 1. As I will discuss below in more detail, none
`
`of the features claimed by the ‘841 Patent were novel as of the claimed priority
`
`date, nor does the ‘841 Patent teach a novel and non-obvious way of combining
`
`these known features.
`
`8.
`
`It is my opinion that each of claims 1-4 and 20-22 of the ‘841 Patent
`
`is invalid under 35 U.S.C. § 103(a), under the legal principles explained to me by
`
`Petitioner’s counsel.
`
`9.
`
`For the purposes of my analysis in this declaration only, and based on
`
`the disclosure and file history of the ‘841 Patent, I provide my proposed
`
`construction of certain claim terms in detail in a later part of this declaration.
`
`A. QUALIFICATIONS AND EXPERIENCE
`1.
`Education and Work Experience
`3
`
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`
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`ViewRay Exhibit 1003
`Page 9 of 184
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`10.
`
`I have summarized in this section my educational background, career
`
`history, and other relevant qualifications. I have also attached a current version of
`
`my Curriculum Vitae as Appendix A.
`
`11.
`
`I am a tenured Professor of radiation oncology and radiology and
`
`Chief of the Division of Medical Physics at the University of Texas Health Science
`
`Center at San Antonio in the Department of Radiation Oncology. I have served on
`
`several task and work groups of AAPM and ASTRO and have been for many years
`
`an examiner for the ABR oral boards. I have also served on the advisory group for
`
`companies in the radiotherapy industry. Currently I am a member of the board of
`
`directors for RTSafe.
`
`12.
`
`In 1989, I received a B.S. degree in Physics from the University of
`
`Athens, in Athens, Greece. In 1991, I received an M.S. in Medical Physics from
`
`the University of Wisconsin in Madison (UW-Madison), and in 1994, I received a
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`Ph.D. in Medicine from UW-Madison.
`
`13.
`
`Previously, I was Director, Radiation Therapy at the Cancer Therapy
`
`and Research Center, San Antonio, TX. Prior to that, I was an Associate Professor
`
`and Chief, Division of Medical Physics at the University of Arkansas for Medical
`
`Sciences, Department of Radiation Oncology, an Associate Professor at Emory
`
`University School of Medicine, Department of Radiation Oncology, and an
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`4
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`Assistant Professor at the University of Kentucky, Department of Radiation
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`Medicine.
`
`14.
`
`My research interests include the development of novel techniques for
`
`the planning and delivery of radiation beams, including several algorithms and
`
`software tools to improve on the accuracy and the quality assurance of intensity
`
`modulated radiation therapy. I also continue to work in this area and study the
`
`effect of tissue heterogeneity in the delivery of hypofractionated regiments to lung
`
`and upper GI patients with stereotactic Body Radiotherapy. Further areas of
`
`interest include investigating the effect of tissue heterogeneity on dose prediction
`
`for photon beams, and development of novel algorithms for the calculation of dose
`
`in radiation therapy treatment planning. I also developed clinical training courses
`
`for physicians, medical physicists, and dosimetrists to share the clinical tools that
`
`my colleagues and I have developed and implemented, and I have published and
`
`presented extensively in this area.
`
`15.
`
`I have co-authored over 150 peer-reviewed publications in these and
`
`other areas. I have been jointly responsible for over $1 million in grants since
`
`1996. Examples of grantors for my research include the Veterans Administration,
`
`San Antonio Area Foundation, Oncology Data Systems, Inc., Initia Corporation,
`
`Direx Corporation, Phillips Medical Systems, and others.
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`5
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`16.
`
`A primary aspect of my research and work over the years has been
`
`treatment planning and delivery of radiation as part of radiation therapy. My work
`
`in these areas extends almost 30 years to the early 1990s when I was a Ph.D.
`
`student at the University of Wisconsin-Madison working on the development of a
`
`dose calculation algorithm for external beam treatment planning. My Ph.D. work
`
`in this area comprised of extending the convolution and superposition dose
`
`calculation algorithm to account more rigorously for the distribution of scatter and
`
`to include the effect of atomic number differences in the calculation. I have since
`
`carried out related research and development including small field and stereotactic
`
`dosimetry, radiobiological modelling, and image guided radiotherapy.
`
`17.
`
`As indicated in my CV, even prior to 2010, I have co-authored at least
`
`120 relevant articles related to radiation therapy and treatment planning, including
`
`my 2009 articles “Monte Carlo Modeling and Commissioning of a Dual-layer
`
`Micro Multileaf Collimator” and “Dosimetric evaluation of multi-pattern spatially
`
`fractionated radiation therapy using a multi-leaf collimator and collapsed cone
`
`convolution superposition dose calculation algorithm.” As well as my 2008
`
`articles, “Dosimetric Characteristics of dual-layer multileaf collimation for small
`
`field and IMRT applications,” and “Quality Assurance of the multileaf collimator
`
`with helical Tomotherapy: design and implementation.” Since 2010, I have
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`6
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`published articles on quality control in radiotherapy and plan optimization, all of
`
`which include the use of multi-leaf collimators for the planning and delivery of the
`
`radiation plans.
`
`18.
`
`Since 2000, I have taught over twenty distinct courses relating to
`
`medical physics, including medical physics residency courses, Advanced
`
`Radiotherapy, and the Physics of Radiation Therapy, as well as directing the
`
`dissertations of five Ph.D. candidates in medical physics. Along with carrying out
`
`research in relevant areas I have been on the Board or served as Advisory Board
`
`member of with the American College of Medical Physics (2008-2010) and
`
`Medical Physics Research Inc. (2007-present). I have or am currently serving as a
`
`Committee Member on the Planning Committee for 2008 National Meeting -
`
`American College of Medical Physics, Strategic Planning Committee - American
`
`College of Medical Physics, Committee on National Meeting Program Planning-
`
`American College of Medical Physics, and Committee on Finance - American
`
`College of Medical Physics.
`
`19.
`
`Among other honors, in 2008 I became a Fellow of the American
`
`College of Medical Physics and in 2009 a Fellow of the American Association of
`
`Physicists in Medicine. In 2016 I received from AAPM the Shalek award of
`
`7
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`
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`excellence in medical physics. In 2018, I was named a fellow of the American
`
`College of Radiology.
`
`20.
`
`I am a currently a member of the American College of Medical
`
`Physics, American College of Radiation Oncology, American Society of
`
`Therapeutic Radiation and Oncology, European Society of Therapeutic Radiation
`
`and Oncology, and the American Association of Physicists in Medicine.
`
`2.
`Compensation
`I am being compensated for the services I am providing in regard to
`
`21.
`
`this IPR petition at $500 per hour. The compensation is not contingent upon my
`
`performance, the outcome of this inter partes review or any other proceedings, or
`
`any issues involved in or related to this inter partes review or any other
`
`proceedings.
`
`3.
`Documents and Other Materials Relied Upon
`The documents on which I rely for the opinions expressed in this
`
`22.
`
`declaration are documents and materials cited by me in this declaration, including
`
`the ‘841 Patent, a patent related to the ‘841 Patent, the prosecution history for the
`
`‘841 Patent and the patent related to the ‘841 Patent, the prior art references and
`
`information discussed in this declaration, including the references attached as
`
`exhibits to the petition for the ‘841 Patent, and any other references specifically
`
`identified in this declaration, in their entirety, even if only portions of these
`8
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`documents are discussed here in an exemplary fashion. I also rely on my
`
`experience in the field and information that I have reviewed in my experience in
`
`the field, even if not specifically referenced in this declaration.
`
`III. STATEMENT OF LEGAL PRINCIPLES
`A.
` Claim Construction
`I understand that the ‘841 Patent is an unexpired patent. I am
`
`23.
`
`informed by counsel that claims in an IPR will be construed under the same
`
`standard as a civil action. I was also informed that under this standard, words in a
`
`claim are generally given their plain meaning, which is the meaning understood by
`
`a person having ordinary skill in the art (PHOSITA) in view of the patent and file
`
`history. Dictionaries or other extrinsic sources may assist in determining the plain
`
`and ordinary meaning but cannot override a meaning that is unambiguous from the
`
`intrinsic evidence. A patentee may expressly define a term in the specification or
`
`prosecution history.
`
`B. Anticipation
`Petitioner’s counsel has advised that in order for a patent claim to be
`
`27.
`
`valid, the claimed invention must be novel. They have further advised that if each
`
`and every element of a claim is disclosed in a single prior art reference, then the
`
`claimed invention is anticipated, and the invention is not patentable according to
`
`pre-AIA 35 U.S.C. § 102 effective before March 16, 2013 or AIA 35 U.S.C. § 102
`9
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`
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`effective after March 16, 2013. I understand that prior art under pre-AIA 35
`
`U.S.C. § 102(b) includes patents or printed publications in the United States or a
`
`foreign country published more than one year prior to the date of the application
`
`for patent in the United States. I understand that prior art under AIA 35 U.S.C. §
`
`102(a) includes patents or printed publications published before the effective filing
`
`date of the claimed invention. In order for the invention to be anticipated, each
`
`element of the claimed invention must be described or embodied, either expressly
`
`or inherently, in the single prior art reference. In order for a reference to inherently
`
`disclose a claim limitation, that claim limitation must necessarily be present in the
`
`reference. Petitioner’s counsel have also advised that a prior art reference must be
`
`enabling in order to anticipate a patent claim.
`
`C. Obviousness
`Petitioner’s counsel has also advised me that obviousness under pre-
`
`28.
`
`AIA 35 U.S.C. § 103 effective before March 16, 2013 or AIA 35 U.S.C. § 103
`
`effective after March 16, 2013 is a basis for invalidity. Specifically, I understand
`
`that where a prior art reference discloses less than all of the limitations of a given
`
`patent claim, that patent claim is invalid if the differences between the claimed
`
`subject matter and the prior art reference are such that the claimed subject matter
`
`as a whole would have been obvious at the time the invention was made to a
`
`person having ordinary skill in the relevant art. Obviousness can be based on a
`10
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`
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`single prior art reference or a combination of references that either expressly or
`
`inherently disclose all limitations of the claimed invention.
`
`29.
`
`I understand that obviousness is not driven by a rigid formula, but is a
`
`flexible inquiry that reflects the fact that a person of ordinary skill in the art
`
`exercising ordinary creativity may find a variety of reasons to combine the
`
`teachings of different references. I understand that a non-exclusive list of possible
`
`factors that may give a person of ordinary skill in the art a reason to combine
`
`references includes combining elements according to known methods to yield
`
`predictable results; simple substitution of known elements to obtain predictable
`
`results; use of known techniques to improve similar devices in the same way;
`
`applying known techniques to known devices ready for improvement to yield
`
`predictable results; choosing from a finite number of identified, predictable
`
`solutions, with a reasonable expectation of success; known work in one field of
`
`endeavor prompting variations of it for use in the same field; and teaching in the
`
`prior art that would have led one of ordinary skill to combine prior art reference
`
`teachings to arrive at the claimed invention.
`
`30.
`
` I also understand that anticipation is the epitome of obviousness.
`
`That is, it is appropriate to consider that a reference that actually anticipates a
`
`claim, also renders obvious that same claim.
`
`11
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`ViewRay Exhibit 1003
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`IV. BACKGROUND OF THE TECHNOLOGY
`A. Radiation therapy and beam collimation
`
`31.
`
`The technology at issue in this IPR relates to radiation therapy, which
`
`uses beams of intense energy to target and destroy cancerous tumor cells. The
`
`radiation beams may be created by a device called a linear accelerator or “linac.”
`
`Because a linac’s high energy beams can damage all living cells in their path
`
`(tumors and healthy tissues alike), it is important to shape the beams to
`
`approximate the shape of the tumor. The technology of the ‘841 patent relates to
`
`this type of beam shaping.
`
`32.
`
`Figure 1 of the ‘841 Patent (reproduced below) depicts a radiotherapy
`
`setup, with a radiation source 102 creating a beam of radiation 103 directed toward
`
`a treatment area 112. Figure 1 also depicts a collimating device 110 which shapes
`
`beam 103 so that it matches the shape of target 112. The target 112 is a tumor
`
`within a patient lying on a treatment couch and located near the radiotherapy
`
`system’s “isocenter” 108. See, e.g., Ex. 1001 (‘841 Patent) at 4:1-29.
`
`12
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`
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`33.
`
`In the early days of radiotherapy, clinicians would machine cut outs
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`from thick blocks of metal to match the shape of a tumor (below, left) but this was
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`expensive and time-consuming. Around 1965, the multi-leaf collimator or “MLC”
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`was invented (see, e.g., below right). MLCs can be used to create numerous
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`shapes using leaves that can be moved in and out of the radiation beam, thus
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`allowing customizable and quicker therapy. It should be noted that MLCs are
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`sometimes referred to as “diaphragms” and leaves are sometimes referred to as
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`“plates.”
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`34.
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`One drawback of multileaf collimators that does not exist with blocks
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`is that radiation can leak between the leaves and strike the patient in unwanted
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`locations (as demonstrated by the red lines and shading in the figure below). This
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`is often referred to as inter-leaf leakage.
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`B. Multi-layer MLCs
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`35.
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`A prior art method for reducing the inter-leaf leakage of MLCs uses
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`multiple layers of MLCs in an offset, stacked design. In the illustration below, the
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`lower layer MLC 200 is offset from the upper layer MLC 100 so that the spaces
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`“s” between the leaves of the top layer are lined up with the middle of the leaves in
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`the lower layer. As a result, leaves 202 in the lower MLC 200 block radiation
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`leaking between leaves 102 of the upper MLC 100.
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`36.
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`This strategy of using an offset double-stack MLC was known in the
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`prior art and is disclosed in the Dai and Noguchi references, as shown in the
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`figures reproduced below.
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`Ex. 1009 (Dai) at 696 (Figure 1) –
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`Ex. 1014 (Noguchi) at Figure 6 –
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`looking down, from above the dual-layer
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`looking down, from above the dual-
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`MLC, it can be seen that the leaves of the
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`layer MLC, it can be seen that the
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`bottom MLC (i.e., the “second layer”
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`leaves of the bottom MLC (shown
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`shown with dotted black lines) are offset
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`with dotted black lines) are offset
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`one-half a leaf width from the leaves of
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`one-half a leaf width from the leaves
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`the top MLC (i.e., the “first layer” shown
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`of the top MLC (shown with solid
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`with red lines).
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`black lines).
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`C.
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`Focusing for improved penumbra
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`37.
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`Beyond interleaf leakage, another concept relevant to the issues in this
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`petition is leaf “focusing.” “Focused” MLC leaves ensure that the radiation beam
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`aimed at a patient’s tumor has sharp (i.e., focused) edges. Sharp beam edges are
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`needed to prevent radiation in the “penumbra” of the beam from striking healthy
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`tissues adjacent to the target tumor.
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`38.
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`While understanding focused leaf designs requires a somewhat
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`challenging visualization of leaves in three-dimensional space, the focusing
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`concept is actually quite simple – for leaves to be focused, they must be designed
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`so their edges (sides and ends) point back toward the radiation source. When this
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`is done, radiation will either pass through the entire attenuating thickness of the
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`leaf or not hit the leaf at all – thus reducing any “penumbra” that occurs when the
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`beam passes through only a portion of the leaf’s thickness.
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`39.
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`When leaf sides are focused back to the source, is common in the art
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`to refer to such an MLC as focused or single-focused. When both the leaf sides
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`and the leaf ends are focused back to the source, it is common in the art to refer to
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`such an MLC as “double focused.”
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`1.
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`Focusing leaf ends – arc leaf movement
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`40.
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`One prior art method of focusing to reduce penumbra is demonstrated
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`in the figures below. The focused design on the right ensures that the leaf ends are
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`always directed toward the radiation source. In this way, radiation is either
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`completely blocked by the full thickness of the leaf or not blocked at all. The
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`beam’s edges are sharp and exhibit minimal penumbra. The design on the left has
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`leaf ends that are rounded and thus only partially block the beam, which results in
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`a beam that is not as sharp at the target and has greater penumbra.
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`41.
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`It was well known before the ‘841 Patent priority date that beam
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`penumbra should be minimized. For example, the Schlegel textbook (Ex. 1011)
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`discusses the focusing properties of MLCs and includes the figures below on page
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`262, in Figure 20.7, which notes that “focusing in the direction of leaf motion
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`can…be realized by the leaves traveling on a circular path (b).”
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`42.
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`Indeed, Schlegel notes in Table 20.2 on page 259 that all of the
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`commercially available MLCs at the time (2006) employed focusing, as shown
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`below.
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`2.
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`Focusing leaf sides – trapezoidal cross-sections
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`43.
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`The ubiquitous “single focusing” used in all the of commercial MLCs
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`listed in Schlegel’s Table 20.2 refers to the focusing of leaf sides. This manner of
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`focusing is based on the same concept of having leaf edges directed back toward
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`the radi