UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`In Re:
`
`U.S. Patent 6,888,919
`
`Inventor: Ulrich Martin Graf :
`
`November 2, 2001
`
`Attorney Docket No. 076695.0106
`
`:
`
`:
`
`Filed:
`
`Issued:
`
`May 3, 2005
`
`:
`
`IPR No. 2016-01904
`
`Assignee: Varian Medical Systems, Inc.
`
`Title: Radiotherapy Apparatus Equipped with an Articulable Gantry for
`Positioning an Imaging Unit
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`Submitted Electronically via the Patent Review Processing System
`
`
`
`DECLARATION OF KENNETH GALL
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`
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`Varian Exhibit 2001, Page 001
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`

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`TABLE OF CONTENTS
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`Page
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`I. Background and Qualifications ............................................................... 1
`A. Educational Background ................................................................. 2
`B. Career History ................................................................................. 2
`C. Publications and Patents .................................................................. 4
`D. Materials and Other Information Considered ................................. 5
`II. Understanding of the Law ....................................................................... 5
`A. Legal Standard for Claim Construction .......................................... 6
`B. Legal Standard for Anticipation .................................................... 11
`C. Legal Standard for Obviousness ................................................... 12
`III. Level of Skill of One of Ordinary Skill in the Art ................................ 14
`IV. Technology Background ....................................................................... 16
`A. State of the Art .............................................................................. 16
`B. Subject Matter of the ’919 Patent .................................................. 27
`V. Claim Construction ............................................................................... 32
`A. “gantry” ......................................................................................... 33
`B. “a second gantry that is rotatable”................................................. 37
`C. “articulable end [of the second gantry]” ....................................... 41
`D. “extending and retracting [the second radiation source]” ............. 43
`VI. Summary of the Prior Art ...................................................................... 45
`A.
`Jaffray ’502 .................................................................................... 45
`B. Watanabe ....................................................................................... 56
`C. Maschke ......................................................................................... 58
`VII. Opinions ................................................................................................ 59
`A.
`Jaffray ’502 Does Not Show a Rotatable Second Gantry. ............ 59
`B.
`Second Radiation Source. ............................................................. 64
`
`Jaffray ’502 Does Not Disclose Extending and Retracting the
`
`
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`i
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`Varian Exhibit 2001, Page 002
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`of Figure 20 and Figure 21 to Show an Articulable End of the
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`C. There is No Motivation to Combine Jaffray ’502’s Embodiments
`Second Gantry. .............................................................................. 71
`D. There is No Motivation to Combine Jaffray ’502 with Watanabe.77
`E. There is No Motivation to Combine Jaffray ’502 and Watanabe
`with Maschke. ............................................................................... 84
`Reservation of Rights .................................................................... 86
`VIII.
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`
`
`
`
`ii
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`Varian Exhibit 2001, Page 003
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`I, Kenneth P. Gall, declare as follows:
`
`1. My name is Kenneth P. Gall, Ph.D. I am currently an
`
`independent technical consultant. I have prepared this report as an expert
`
`witness retained by Varian Medical Systems, Inc. (“Varian”). In this report I
`
`give my opinions as to whether certain claims of U.S. Patent No. 6,888,919
`
`(“the ’919 Patent”) are invalid. I provide technical bases for these opinions
`
`as appropriate.
`
`2.
`
`This report contains statements of my opinions formed to date
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`and the bases and reasons for those opinions. I may offer additional
`
`opinions based on further review of materials in this case, including opinions
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`and/or testimony of other expert witnesses. I make this declaration based
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`upon my own personal knowledge and, if called upon to testify, would
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`testify competently to the matters contained herein. For my efforts in
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`connection with the preparation of this declaration I have been compensated
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`at my customary consulting rate. My compensation is in no way contingent
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`on the results of these or any other proceedings relating to the above-
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`captioned patent.
`
`I.
`
`BACKGROUND AND QUALIFICATIONS
`3.
`
`I have summarized in this section my educational background,
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`career history, publications, and other relevant qualifications. My full
`
`
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`1
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`Varian Exhibit 2001, Page 004
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`
`curriculum vitae is attached as Appendix A to this report.
`
`A. Educational Background
`4.
`I received a Bachelor of Arts degree in 1981 from Colby
`
`College in Waterville, ME. I received a Master of Arts in Physics in 1985
`
`and a Doctor of Philosophy in Nuclear/Particle Physics in 1989 from Boston
`
`University in Boston, MA.
`
`B. Career History
`5.
`I have approximately 28 years of experience working in
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`radiation therapy treatment system development, radiation dosimetry, and
`
`automation of image-guided patient positioning for radiation therapy. I have
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`gained this experience working in research institutions, universities,
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`hospitals, and corporations.
`
` I have been certified
`
`in Therapeutic
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`Radiological Physics by the American Board of Radiology since 1994. I
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`have worked on many projects and technologies highly relevant to the
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`subject matter of the ’919 Patent.
`
`6.
`
`I have held the following academic appointments: (1) Instructor
`
`in Radiation Therapy, Harvard Medical School, Massachusetts General
`
`Hospital, from 1988-1996; (2) Associate Professor, with Tenure, University
`
`of Texas Southwestern Medical School, from 1996-2003; and (3) Visiting
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`Scientist, Plasma Science and Fusion Center, Massachusetts Institute of
`
`
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`2
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`Varian Exhibit 2001, Page 005
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`Technology, from 2003-2006.
`
`7.
`
`During portions of my academic appointments, I also held a
`
`number of hospital appointments, including: (1) Assistant in Radiation
`
`Therapy (Biophysics) at Massachusetts General Hospital in Boston, MA,
`
`from 1988-1990; (2) Assistant Radiation Biophysicist at Massachusetts
`
`General Hospital in Boston, MA, from 1990-1996; (3) Director of Physics
`
`and Dosimetry at Parkland Health and Hospital System in Dallas, TX, from
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`1996-2002; (4) Director of Physics and Dosimetry at St. Paul University
`
`Hospital in Dallas, TX, from 2000-2002; and (5) Director of UT
`
`Southwestern Radiosurgery Program at Zale-Lipshy University Hospital in
`
`Dallas, TX, from 1996-2003.
`
`8.
`
`I have held a number of other professional, corporate, and
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`major visiting appointments between 1998 to the present. I have served on a
`
`number of committees supporting local, regional, and national radiation
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`therapy, physics, and/or therapeutic radiology and oncology organizations.
`
`9.
`
`I have been certified by the American Board of Radiology in
`
`Therapeutic Radiological Physics since 1994. I have also been licensed by
`
`the State of Texas in Therapeutic Radiological Physics since 1997.
`
`10. From 2003-2005, I was the founder and CEO of Still River
`
`Systems, a company formed to design, build, and sell advanced, cutting edge
`
`
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`3
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`Varian Exhibit 2001, Page 006
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`radiotherapy systems.
`
`11. From 2005-2012, I was the Chief Technology Officer for Still
`
`River Systems and Mevion Medical Systems. The company changed its
`
`name from Still River Systems to Mevion Medical Systems in 2011. From
`
`2004-2012, I was a Corporate Officer at Still River Systems/Mevion
`
`Medical Systems. At this company I led the design and development efforts
`
`of multiple radiotherapy treatment delivery and diagnostic imaging systems.
`
`The systems I developed at Still River Systems / Mevion Medical Systems
`
`included the design of a particle accelerator, the design of supporting
`
`structures and multiple gantries to hold and position both therapeutic and
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`diagnostic imaging sources and imaging receptors, the design of patient
`
`support devices and the design of controls systems to coordinate the clinical
`
`workflow of all of the sub-systems to facilitate the efficient and precise
`
`treatment of radiotherapy patients. As the program manager for these design
`
`and development activities I also was responsible for the regulatory
`
`compliance of the designs.
`
`C.
`12.
`
`Publications and Patents
`
`I have 14 granted U.S. patents and a number of foreign patents
`
`in technical fields that are related to the field of the ’919 Patent, namely
`
`radiation therapy and systems for delivery of radiation therapy. I also have
`
`
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`4
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`Varian Exhibit 2001, Page 007
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`multiple additional patents, domestic and foreign, that have been filed and
`
`are not yet published.
`
`13.
`
`I am the co-author of 28 peer-reviewed articles that describe
`
`and/or explain research that I conducted within technical fields that are
`
`related to the ’919 Patent. I have published numerous peer-reviewed journal
`
`papers in the field of radiotherapy concerning the alignment of patients for
`
`radiotherapy treatment, and the importance of proper alignment. I have also
`
`designed, built, tested, and clinically implemented systems for both the
`
`imaging of patients prior to radiotherapy treatment and for radiotherapy
`
`treatment itself.
`
`14. Attached as Appendix A is my curriculum vitae, which
`
`includes more information regarding my qualifications.
`
`D. Materials and Other Information Considered
`15.
`I have considered information from various sources in forming
`
`my opinions. I have reviewed and considered each of the exhibits listed in
`
`the attached Appendix B (Appendix of Exhibits) in forming my opinions.
`
`II.
`
`UNDERSTANDING OF THE LAW
`16. My opinions are also formed by my understanding of the
`
`relevant law. I understand that patentability of a patent is analyzed on a
`
`claim-by-claim basis, from the perspective of a hypothetical person of
`
`
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`5
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`Varian Exhibit 2001, Page 008
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`ordinary skill in the art (“POSITA”).
`
`17.
`
`I understand that earlier publications and patents, which may be
`
`referred to as “prior art,” may act to render a patent unpatentable for one of
`
`two reasons: (a) anticipation, and (b) obviousness. I further understand that
`
`the prior art must be viewed from the perspective of a POSITA at the time of
`
`the invention.
`
`A. Legal Standard for Claim Construction
`18.
`I understand that a patent may include two types of claims,
`
`independent claims and dependent claims. An independent claim stands
`
`alone and includes only the limitations it recites. A dependent claim can
`
`depend from an independent claim or another dependent claim. I understand
`
`that a dependent claim includes all the limitations that it recites in addition to
`
`all of the limitations recited in the claim from which it depends.
`
`19.
`
`It is my understanding that in proceedings before the PTAB the
`
`claims of an unexpired patent are to be given their broadest reasonable
`
`interpretation in light of the specification from the perspective of one of skill
`
`in the art.
`
`20.
`
`In comparing the claims of the ’919 Patent to the prior art, I
`
`have carefully considered the ’919 Patent and its file history in light of the
`
`understanding of a person of skill at the time of the alleged invention.
`
`
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`6
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`Varian Exhibit 2001, Page 009
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`21.
`
`I understand that to determine how a person of ordinary skill
`
`would understand a claim term, one should look to those sources available
`
`that show what a person of skill in the art would have understood disputed
`
`claim language to mean. Such sources include the words of the claims
`
`themselves, the remainder of the patent’s specification, the prosecution
`
`history of the patent (all considered “intrinsic” evidence), and “extrinsic”
`
`evidence concerning relevant scientific principles, the meaning of technical
`
`terms, and the state of the art.
`
`22.
`
`I understand that, in construing a claim term, one looks
`
`primarily to the intrinsic patent evidence, including the words of the claims
`
`themselves, the remainder of the patent specification, and the prosecution
`
`history.
`
`23.
`
`I understand that extrinsic evidence, which is evidence external
`
`to the patent and the prosecution history, may also be useful in interpreting
`
`patent claims when the intrinsic evidence itself is insufficient.
`
`24.
`
`I understand that words or terms should be given their ordinary
`
`and accepted meaning unless it appears that the inventors were using them to
`
`mean something else. In making this determination, the claims, the patent
`
`specification, and the prosecution history are of paramount importance.
`
`Additionally, the specification and prosecution history must be consulted to
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`
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`7
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`Varian Exhibit 2001, Page 010
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`confirm whether the patentee has acted as its own lexicographer (i.e.,
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`provided its own special meaning to any disputed terms), or intentionally
`
`disclaimed, disavowed, or surrendered any claim scope.
`
`25.
`
`I understand that the claims of a patent define the scope of the
`
`rights conferred by the patent. The claims particularly point out and
`
`distinctly claim the subject matter which the patentee regards as his
`
`invention. Because the patentee is required to define precisely what he
`
`claims his invention to be, it is improper to construe claims in a manner
`
`different from the plain import of the terms used consistent with the
`
`specification. Accordingly, a claim construction analysis must begin and
`
`remain centered on the claim language itself. Additionally, the context in
`
`which a term is used in the challenged claim can be highly instructive.
`
`26. Likewise, other claims of
`
`the patent
`
`in question, both
`
`challenged and non-challenged, can inform the meaning of a claim term.
`
`For example, because claim terms are normally used consistently throughout
`
`the patent, the usage of a term in one claim can often illuminate the meaning
`
`of the same term in other claims. Differences among claims can also be a
`
`useful guide in understanding the meaning of particular claim terms.
`
`27.
`
`I understand that the claims of a patent define the purported
`
`invention. I understand that the purpose of claim construction is to
`
`
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`8
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`Varian Exhibit 2001, Page 011
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`

`
`understand how one skilled in the art would have understood the claim terms
`
`at the time of the purported invention.
`
`28.
`
`I understand that a person of ordinary skill in the art is deemed
`
`to read a claim term not only in the context of the particular claim in which
`
`the disputed term appears, but in the context of the entire patent, including
`
`the specification. For this reason, the words of the claim must be interpreted
`
`in view of the entire specification. The specification is the primary basis for
`
`construing
`
`the claims and provides a safeguard such
`
`that correct
`
`constructions closely align with
`
`the specification.
`
` Ultimately,
`
`the
`
`interpretation to be given a term can only be determined and confirmed with
`
`a full understanding of what the inventors actually invented and intended to
`
`envelop with the claim as set forth in the patent itself.
`
`29.
`
`I understand that it is improper to place too much emphasis on
`
`the ordinary meaning of the claim term without adequate grounding of that
`
`term within the context of the specification of the challenged patent. Hence,
`
`claim terms should not be broadly construed to encompass subject matter
`
`that, although technically within the broadest reading of the term, is not
`
`supported when the claims are read in light of the invention described in the
`
`specification. Put another way, claim terms are given their broadest
`
`reasonable interpretation that is consistent with the specification and the
`
`
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`9
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`Varian Exhibit 2001, Page 012
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`

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`prosecution history. Art incorporated by reference or otherwise cited during
`
`the prosecution history is also highly relevant in ascertaining the breadth of
`
`claim terms.
`
`30.
`
`I understand that the role of the specification is to describe and
`
`enable the invention. In turn, the claims cannot be of broader scope than the
`
`invention that is set forth in the specification. Care must be taken lest word-
`
`by-word definition, removed from the context of the patent, leads to an
`
`overall result that departs significantly from the patented invention.
`
`31.
`
`I understand that claim terms must be construed in a manner
`
`consistent with the context of the intrinsic record. In addition to consulting
`
`the specification, one should also consider the patent’s prosecution history,
`
`if available. The prosecution file history provides evidence of how both the
`
`Patent Office and the inventors understood the terms of the patent,
`
`particularly in light of what was known in the prior art. Further, where the
`
`specification describes a claim term broadly, arguments and amendments
`
`made during prosecution may require a more narrow interpretation.
`
`32.
`
`I understand that while intrinsic evidence is of primary
`
`importance, extrinsic evidence, e.g., all evidence external to the patent and
`
`prosecution history, including expert and inventor testimony, dictionaries,
`
`and learned treatises, can also be considered. For example, technical
`
`
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`10
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`Varian Exhibit 2001, Page 013
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`dictionaries may help one better understand the underlying technology and
`
`the way in which one of skill in the art might use the claim terms. Extrinsic
`
`evidence should not be considered, however, divorced from the context of
`
`the
`
`intrinsic evidence.
`
` Evidence beyond
`
`the patent specification,
`
`prosecution history, and other claims in the patent should not be relied upon
`
`unless the claim language is ambiguous in light of these intrinsic sources.
`
`Furthermore, while extrinsic evidence can shed useful light on the relevant
`
`art, it is less significant than the intrinsic record in determining the legally
`
`operative meaning of claim language.
`
`B.
`33.
`
`Legal Standard for Anticipation
`
`I understand that, once the claims of a patent have been
`
`properly construed, the second step in determining anticipation of a patent
`
`claim requires a comparison of the properly construed claim language to the
`
`prior art on a limitation-by-limitation basis.
`
`34.
`
`I understand that a prior art reference “anticipates” a challenged
`
`claim, and thus renders the claim invalid, only if all elements of the claim
`
`are disclosed in that prior art reference, either explicitly or inherently (i.e.,
`
`necessarily present or implied).
`
`35.
`
`I have written this declaration with the understanding that in an
`
`inter partes review anticipation must be shown by a preponderance of the
`
`
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`11
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`Varian Exhibit 2001, Page 014
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`evidence.
`
`C. Legal Standard for Obviousness
`36.
`I understand that the prior art may render a patent claim
`
`“obvious.” I understand that one or more prior art references that
`
`individually disclose fewer than all elements of a patent claim may
`
`nevertheless be relied upon to render a patent claim obvious if the claimed
`
`invention would have been obvious to a POSITA based on the collective
`
`teachings of the prior art and the knowledge of a POSITA at the time of the
`
`invention.
`
`37.
`
`I understand that a claim may only be deemed invalid for
`
`obviousness in light of a single prior art reference, without the need to
`
`combine references, if the elements of the claim that are not found in the
`
`reference can be supplied by the knowledge or common sense of one of
`
`ordinary skill in the relevant art.
`
`38.
`
`I understand that a claim may be obvious in light of multiple
`
`prior art references that disclose the claim elements if a POSITA would have
`
`been motivated to combine the references in a manner that would result in
`
`the claimed invention or render it obvious. I understand that this motivation
`
`to combine need not be explicit in any of the prior art, but may be inferred
`
`from the knowledge of a POSITA at the time the patent was filed.
`
`
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`12
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`Varian Exhibit 2001, Page 015
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`39.
`
`I further understand that a claim may be obvious where fewer
`
`than all of the elements of the claim are disclosed by the prior art references
`
`if including the missing element would have been obvious to a POSITA,
`
`e.g., the missing element represents only an insubstantial difference over the
`
`prior art, or a reconfiguration of a known system.
`
`40.
`
`I understand that obviousness is based on the scope and content
`
`of the prior art, the differences between the prior art and the claim, the level
`
`of ordinary skill in the art, and secondary indications of obviousness and
`
`non-obviousness to the extent they exist. I understand that under the
`
`doctrine of obviousness, a claim may by invalid if the differences between
`
`the invention and the prior art are such that the subject matter as a whole
`
`would have been obvious to a POSITA at the time the invention was made.
`
`41.
`
`I understand that a showing of obviousness requires an
`
`articulated reason with a rational underpinning to combine specific teachings
`
`in the prior art references in a particular manner to arrive at the claimed
`
`invention. Arguing that references are analogous to the invention of the
`
`patent at issue or to each other is insufficient. Merely restating the claim
`
`language as an alleged motivation to combine would present a circular
`
`rationale that would fail to provide a sufficient reason as to why one of
`
`ordinary skill in the art would have been prompted to combine the teachings
`
`
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`13
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`Varian Exhibit 2001, Page 016
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`of the references.
`
`42.
`
`I understand that prior art combinations that change the basic
`
`principles under which the prior art was designed to operate, or that render
`
`the prior art inoperable for its intended purpose, cannot be used to support a
`
`conclusion of obviousness.
`
`43.
`
`I understand
`
`that
`
`the obviousness analysis
`
`requires a
`
`comparison of the properly construed claim language to the prior art on a
`
`limitation-by-limitation basis.
`
`44.
`
`I have written this declaration with the understanding that in an
`
`inter partes review obviousness must be shown by a preponderance
`
`evidence.
`
`III.
`
`LEVEL OF SKILL OF ONE OF ORDINARY SKILL IN THE
`ART
`45.
`
`In determining the characteristics of a hypothetical person of
`
`ordinary skill in the art of the ’919 Patent at the time of the claimed
`
`invention, I considered several factors, including the sophistication of the
`
`technology involved in the ’919 Patent, and the educational background and
`
`experience of those working in the field in the 2001 time period. I also
`
`considered the various approaches to design and the use of diagnostic
`
`imaging for treatment targeting, the problems encountered in the art, and the
`
`speed of innovation in the art. Finally, I placed myself back in the 2001
`
`
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`14
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`Varian Exhibit 2001, Page 017
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`timeframe and considered medical physics students I
`
`taught and
`
`radiotherapy experts I had worked with in the field. In my opinion, a person
`
`of ordinary skill in the art for the ’919 Patent would have a post-graduate
`
`degree in physics or engineering, with significant exposure to the principles
`
`of radiation generation and deposition in human subjects, or at least two
`
`years of experience in the field of radiotherapy with at least a Bachelor of
`
`Science degree in mechanical engineering, applied physics, or electrical
`
`engineering; or the equivalent of all of the above. A person with less
`
`education but more relevant practical experience may also meet this
`
`standard. I meet these criteria and consider myself a person of at least
`
`ordinary skill in the art pertaining to the ’919 Patent. I was such a person by
`
`at least 2001. It would be necessary for a person to have these qualifications
`
`in order to read and understand the ’919 Patent.
`
`46.
`
`I understand that Petitioner’s expert Dr. Kenneth David
`
`Steidley has provided an opinion that a person of ordinary skill in the art in
`
`November 2001 would be a person “with a graduate degree (M.S. or Ph.D.)
`
`in medical physics or a related field (e.g., physics or engineering), and three
`
`years of work in physics, engineering, or radiation oncology beyond the
`
`completion of his or her degree.” Ex. 1002 at ¶ 25. While I believe that Dr.
`
`Steidley overestimates the level of skill of a person of ordinary skill in the
`
`
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`15
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`Varian Exhibit 2001, Page 018
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`art, in an effort to make the obviousness challenges here easier, I believe that
`
`even under Dr. Steidley’s flawed position, my conclusions below would not
`
`change.
`
`IV.
`
`TECHNOLOGY BACKGROUND
`A.
`State of the Art
`47. At the time the ’919 Patent was filed, radiation therapy, or
`
`radiotherapy, was a well-practiced method of treatment for cancer patients,
`
`using ionizing radiation to kill cancer cells. By 2001, “the use of linear
`
`accelerators for the generation of either electron radiation or X-ray radiation
`
`[was] well known.” Ex. 1001 at 1:14-15; see also Ex. 2005 at 1:21-22. A
`
`radiotherapy system was a specialized system that would mount a linear
`
`accelerator (“linac”) or other radiation source into a position so that a
`
`patient’s tumor would be exposed to the resulting radiation beam. Because
`
`of the high-energy radiation involved in radiotherapy, it was important that
`
`the treatment minimize the radiation dose received by the patient’s healthy
`
`tissue, while ensuring that the tumors receive the full dose necessary for
`
`effective treatment. See Ex. 1001 at 4:58-62; Ex. 2005 at 1:22-26. Accurate
`
`positioning of the patient relative to the treatment apparatus was therefore
`
`essential to improving the chances of a successful treatment. See Ex. 1001
`
`at 1:28-29.
`
`
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`16
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`Varian Exhibit 2001, Page 019
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`
`48. Several factors could affect the accuracy of the radiotherapy
`
`treatment. One was ensuring that the location of the tumor within the patient
`
`was known during treatment, or shortly before treatment commenced. It was
`
`important to minimize delays or movement of the patient between
`
`determining the location of the tumor and performing treatment. Soft tissues
`
`in the human body, including organs and tumors, could move over time,
`
`including while breathing, during movement, or even just naturally,
`
`independent of other factors. See, e.g., Ex. 1001 at 1:30-34, 2:45-47.
`
`Therefore, too long of a delay between determining the location of the tumor
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`and beginning treatment could result in shifts in the soft tissues. If the
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`treatment method did not adjust for any movement, any misplacement of the
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`therapeutic radiation could result in the tumor not receiving an effective dose
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`of radiation, and/or healthy tissue of the patient receiving a high dose of
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`radiation.
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`49. Obtaining radiation-based diagnostic images of a patient (such
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`as X-ray images) just prior to performing therapeutic treatment could
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`confirm the position of a tumor within the patient. The therapeutic radiation
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`source of a radiotherapy system could theoretically be used for diagnostic
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`imaging; however, the image quality was usually very poor, as the high-
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`energy radiation did not provide as much soft-tissue contrast. See, e.g., Ex.
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`
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`17
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`1001 at 1:40-53. Therefore, a separate diagnostic radiation source such as a
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`low-energy X-ray could be used for diagnostic imaging as part of the
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`radiotherapy treatment. See, e.g., id. at 1:53-67. In some systems, a
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`diagnostic radiation source could also be used for 3D computerized
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`tomography
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`(CT)
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`scans, which would
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`enable
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`three-dimensional
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`reconstruction of the target volume and surrounding soft tissue. See, e.g.,
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`Ex. 1001 at 4:50-58. A 3D image of the target volume could be used for
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`improved treatment planning.
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`50.
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`In addition to the use of diagnostic imaging to verify the
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`position of the target volume, it was also desirable that the radiotherapy
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`system ensured that the therapeutic radiation source is positioned properly
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`and minimizes any unnecessary movement. However, some radiotherapy
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`systems did require at least some movement of components to provide a
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`radiation beam at multiple angles relative to the patient. These systems
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`allowed for a concentration of a radiation dose on a target volume within a
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`patient’s body from multiple angles (or even a continuous arc). At the same
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`time, the healthy cells surrounding the target volume were spared the full
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`brunt of the radiation dose, as different healthy cells were exposed to
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`radiation at different angles. A radiotherapy system could provide radiation
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`from multiple angles either by using multiple radiation sources place around
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`
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`the patient, or by allowing a radiation source to rotate around the patient.
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`See, e.g., Ex. 1001 Fig. 1A; Ex. 1010 at 3, Fig. 1. With a rotating
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`therapeutic radiation source, it was important that any movement of the
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`therapeutic radiation sources be performed in a precisely-controlled manner
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`to achieve the benefits of a rotating therapeutic source, without unnecessary
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`movement adversely affecting placement of the beam. See Ex. 2005 at 2:23-
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`27 (discussing radiation therapy system in which the movement of the
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`therapeutic source is “constrained to a single plane,” which “provides a
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`number of benefits over” systems that permit additional movement).
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`51.
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`In some radiotherapy systems, adding flexibility and movement
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`of particular components (such as a diagnostic X-ray) could offer additional
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`advantages. The gantry and attached equipment used in many radiotherapy
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`systems weighed several tons and were positioned surrounding the patient,
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`and movement of a particular component could require the movement of the
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`entire system, which could require additional time and energy. An example
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`radiotherapy system cited by Petitioner shows at least four components of a
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`rotatable gantry that were adjacent to the patient:
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`
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`
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`Ex. 1010 at 3 (Fig. 1(b)); see also Pet. at 7. In this example, the
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`various components (labeled “MV Source,” “kV Imager,” “kV x-ray tube,”
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`and “MV Imager”) were mounted on a gantry, and the components could
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`rotate in unison around the patient via the drum structure of the gantry
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`against the wall. Allowing some of these components to move relative to
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`the rest of the system in a specific, controlled manner could offer greater
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`flexibility in the system; however, allowing the components to move freely
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`would be detrimental to the operation of a radiotherapy system, as explained
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`below.
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`52. There were several considerations in the design and building of
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`radiotherapy systems that a POSITA would have taken into account. For
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`example, standards for medical electrical equipment set by the International
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`
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`20
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`Electrotechnical Commission (“IEC”)1 required that heavy equipment such
`
`as linacs that were used in proximity to patients have a speed limit, to ensure
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`that they could be stopped quickly for safety purposes. Ex. 2006 (IEC
`
`60601-2-1) at 8. Linacs were typically restricted to a movement speed of
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`approximately one revolution per minute. Id. Another consideration was
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`the ease of access to the patient. While the patient usually lay on a treatment
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`couch that could then be slid into an operative position, if an emergency or
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`other issue arose while the radiotherapy system was in use, it would have
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`been desirable for the radiation technologist to have quick access to the
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`patient. The speed of a rotating gantry and patient accessibility were
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`considerations in the design of radiotherapy systems. Because of the
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`
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`1 Compliance with IEC standards was needed for a product to receive a “CE”
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`mark indicating approval for use in the European Union. I have reviewed
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`the document marked Exhibit 2006 and