UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`ELEKTA INC.
`
`Petitioner
`
`v.
`
`VARIAN MEDICAL SYSTEMS, INC.
`
`Patent Owner
`
`
`
`IPR2016-01902
`Patent No. 6,888,919
`
`DECLARATION OF KENNETH DAVID STEIDLEY, Ph.D.
`
`
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`Page 1 of 75
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`Elekta Exhibit 1002
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`TABLE OF CONTENTS
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`Introduction ...................................................................................................... 1
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`Qualifications ................................................................................................... 2
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`
`
`I.
`
`II.
`
`III. Compensation .................................................................................................. 4
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`IV.
`
`Information Considered ................................................................................... 4
`
`V. Anticipation Principles .................................................................................... 5
`
`VI. Obviousness Principles .................................................................................... 5
`
`VII. Person of Ordinary Skill in the Art .................................................................. 7
`
`VIII. Technology Background: Radiation Therapy ................................................. 8
`
`A.
`
`Radiation Treatment Machines ............................................................. 8
`
`1.
`
`Patient Imaging ......................................................................... 15
`
`a)
`
`b)
`
`Therapeutic (“MV” or “Portal”) Imagers ....................... 16
`
`Diagnostic (or “kV”) Imagers......................................... 19
`
`2.
`
`Prior Mechanisms for Positioning Imagers and Sources .......... 21
`
`a)
`
`Prior Art Recognized in ’919 Patent .............................. 23
`
`b) Munro ............................................................................. 25
`
`c) Watanabe ........................................................................ 26
`
`d)
`
`e)
`
`Barnea ............................................................................. 27
`
`Grady .............................................................................. 28
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`IX. Overview of the ’919 Patent .......................................................................... 29
`
`X.
`
`Claim Construction ........................................................................................ 32
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`
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`i
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`A.
`
`B.
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`C.
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`“gantry” [claims 1, 2, 9, 11, and 13] ................................................... 33
`
`“an articulable end of the second gantry” [claims 1 and 13] .............. 34
`
`“rotatable” [claims 1 and 13] .............................................................. 35
`
`XI. Claims 1-4, 9, 11, and 13 Are Unpatentable Based on the Disclosure
`of Barnea in view of Watanabe ..................................................................... 36
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`[Claim 1, element 1.a] “An apparatus comprising” .................. 36
`
`[Claim 1, element 1.b] “a first therapeutic radiation
`source attached to a first gantry” .............................................. 37
`
`[Claim 1, element 1.c] “at least one second radiation
`source”....................................................................................... 38
`
`[Claim 1, element 1.d] “a second gantry that is rotatable,
`the second gantry is attached to the first gantry” ...................... 39
`
`[Claim 1, element 1.e] “an imager attached to an
`articulable end of the second gantry” ....................................... 41
`
`[Claim 2] “The apparatus of claim 1, wherein at least one
`second radiation source is attached to the second gantry” ....... 46
`
`[Claim 3] “The apparatus of claim 1, wherein the first
`therapeutic radiation source to propagate therapeutic
`energy at a first energy level” ................................................... 47
`
`[Claim 4] “The apparatus of claim 1, wherein at least one
`second radiation source to propagate diagnostic energy at
`a second energy level” .............................................................. 48
`
`[Claim 9] “The apparatus of claim 1, wherein the
`articulable end comprises at least one pivot point
`between the second gantry and the imager” ............................. 48
`
`10.
`
`[Claim 11] “The apparatus of claim 1, wherein the
`articulable end is capable of folding the imager against
`the second gantry” ..................................................................... 50
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`11.
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`12.
`
`13.
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`14.
`
`[Claim 13, element 13.a] “An apparatus comprising” .............. 52
`
`[Claim 13, element 13.b] “a first radiation source
`attached to a first gantry” .......................................................... 52
`
`[Claim 13, element 13.c] “at least one second radiation
`source”....................................................................................... 53
`
`[Claim 13, element 13.d] “a second gantry that is
`rotatable, wherein the second gantry is capable of
`extending and retracting the second radiation source
`attached to the second gantry” .................................................. 53
`
`15.
`
`[Claim 13, element 13.e] “an imager attached to an
`articulable end of the second gantry” ....................................... 57
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`XII. Claim 13 Is Unpatentable Based on the Disclosure of Grady ....................... 57
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`[Claim 13, element 13.a] “An apparatus comprising” .............. 58
`
`[Claim 13, element 13.b] “a first radiation source
`attached to a first gantry” .......................................................... 58
`
`[Claim 13, element 13.c] “at least one second radiation
`source”....................................................................................... 59
`
`[Claim 13, element 13.d] “a second gantry that is
`rotatable, wherein the second gantry is capable of
`extending and retracting the second radiation source
`attached to the second gantry” .................................................. 60
`
`[Claim 13, element 13.e] “an imager attached to an
`articulable end of the second gantry” ....................................... 62
`
`XIII. Conclusion ..................................................................................................... 65
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`I, Dr. Kenneth David Steidley, declare as follows:
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`I.
`
`Introduction
`
`1. My name is Kenneth David Steidley. I am currently a consultant in
`
`radiation oncology after having served for over 30 years as the Chief
`
`Physicist at St. Barnabas Medical Center in Livingston, New Jersey (“St.
`
`Barnabas”) from 1975 until 2006.
`
`2. My private practice in the last 10 years has had two major clients: St.
`
`Barnabas, where I worked part time to cover lack of physics staff, and the
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`Veterans Administration Hospital in East Orange, New Jersey (“Veterans
`
`Hospital”). At the Veterans Hospital, paid as a consultant but as the de facto
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`Chief Physicist, I directed the reopening of their Radiation Department. I
`
`hired new staff and helped supervise reconstruction and the installment of
`
`modern radiotherapy equipment in 2007. While at the Veterans Hospital, I
`
`worked with a Philips CT-simulator and two linear accelerators, the Elekta
`
`Infinity, and the Siemens Impression Plus. I was responsible for all initial
`
`clinical medical physics work there until new hires became functional.
`
`3.
`
`I have been retained by Elekta Inc. (“Elekta” or “Petitioner”) as an
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`independent expert consultant in this inter partes review (“Petition”) before
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`the United States Patent and Trademark Office.
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`
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`1
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`4.
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`5.
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`6.
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`I understand that this proceeding involves U.S. Patent No 6,888,919 to Graf
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`(“the ’919 patent”) (attached as Ex. 1001 to Elekta’s Petition).
`
`I understand that Varian Medical Systems owns the ’919 patent.
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`I have been asked to investigate and opine on certain issues relating to the
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`’919 patent and to consider whether certain references disclose or suggest
`
`the features recited in claims 1, 2, 3, 4, 9, 11, and 13 of the ’919 patent. As
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`explained in detail below, in my opinion: (1) claims 1-4, 9, 11, and 13 are
`
`rendered obvious by Barnea in view of Watanabe; (2) and claim 13 is
`
`anticipated by Grady.
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`II. Qualifications
`
`7. My curriculum vitae, which includes a more detailed summary of my
`
`background, experience, and publications, is attached as Appendix A.
`
`8.
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`I have either trained or worked in the radiotherapy field for over 40 years. I
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`am currently a consultant in radiation oncology, and I previously held the
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`position of Chief Physicist at St. Barnabas from 1975 until 2006 and Chief
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`Physicist at the Veterans Hospital from January 1974 to September 1975.
`
`9.
`
`I have developed and worked with a variety of diagnostic and therapeutic
`
`radiology equipment
`
`including commissioning, periodic calibration,
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`treatment planning, and attending to service issues. On therapy units I did,
`
`or supervised, treatment plans for about 1,000 patients per year. I used
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`several Siemens linear accelerators, including the Primus (2001-2009), KD-
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`2 (1994-2005), and the Model 5800 (1987-2000). I also worked with Varian
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`linear accelerators, including the Clinac 18 Model (1986-1994) and the
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`6/100 Model (1994-2001). Further, I have experience using (1) the
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`Tomotherapy Accelerator (Hi-Art model), an IMRT (Intensity Modulated
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`Radiation Therapy) treatment device that uses a spiral delivery pattern with
`
`6 MV x-rays (2005-2009), (2) the Siemens Model 1750 conventional
`
`simulator (1993-2005), (3) the Haynes radiographic simulator (about 1985-
`
`1987), (4) the Picker computed tomography (CT) simulator (1998-2009),
`
`and (5) the Philips CT-simulator (2005-2009).
`
`10.
`
`I have also co-designed and commissioned a fully rotating simulator used to
`
`take diagnostic images of patients with Haynes, Ltd. I also co-designed and
`
`commissioned a new type of low energy accelerator (Model 5800) with
`
`Siemens Corporation.
`
`11.
`
`I graduated with my Ph.D. in Radiation Science from Rutgers University in
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`1977, where I wrote my thesis on “Integral Dose and Correlation with
`
`Leukocyte Count.” I have authored or co-authored over 100 peer-reviewed
`
`publications and presentations and co-designed simulators and accelerators.
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`I have been board-certified in Therapeutic Radiologic Physics by the
`
`American Board of Radiology since 1975 and was boarded by the American
`
`
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`3
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`Board of Medical Physics in Radiation Oncology Physics in 1991. My
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`training, clinical, and management experience qualify me as a person skilled
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`in the art of radiotherapy physics.
`
`12.
`
`I am not an attorney and offer no legal opinions, but in the course of my
`
`work, I have had experience studying and analyzing patents and patent
`
`claims from the perspective of a person skilled in the art.
`
`III. Compensation
`
`13.
`
`I am being compensated at my standard rate of $300 per hour for the time I
`
`spend on this matter. No part of my compensation depends on my
`
`performance, the outcome of this proceeding, or any issues involved in or
`
`IV.
`
`14.
`
`related to this inter partes review proceeding.
`
`Information Considered
`
`In forming my opinions, I have relied on the ’919 patent, its prosecution
`
`history before the USPTO, and materials cited in Elekta’s Petition that are
`
`listed in the attached Appendix B. I have also relied on my own experience
`
`and expertise of the knowledge of the person of ordinary skill in the relevant
`
`art in the timeframe of November 2, 2001, which I understand is the earliest
`
`potential effective filing date of the application that became the ’919 patent.
`
`15. This declaration is based on information currently available to me. To the
`
`extent additional information becomes available, I reserve the right to
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`continue my investigation and study, which may include a review of
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`documents and information that recently have been or may be produced, as
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`well as testimony from depositions that may be taken after I complete this
`
`declaration.
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`16. For convenience, I have included exhibit numbers in this declaration that I
`
`understand are the exhibit numbers being used in the Petition.
`
`V. Anticipation Principles
`
`17.
`
`I understand that for a patent claim to be anticipated under pre-AIA 35
`
`U.S.C. § 102, a single prior art document must disclose, either expressly or
`
`inherently, each and every claim limitation. I further understand that to be
`
`inherently anticipated, a single prior art document must necessarily and
`
`inevitably disclose the claim limitations at issue. For a patent claim to be
`
`anticipated under § 102(b), I understand that the claim must have been
`
`patented or described in a printed publication in any country, or in public use
`
`or on sale in the United States, more than one year prior to the United States
`
`patent application date (i.e., before November 2, 2000).
`
`VI. Obviousness Principles
`
`18.
`
`I have been advised that a patent claim may be invalid as obvious and
`
`unpatentable under pre-AIA 35 U.S.C. § 103 if the differences between the
`
`subject matter patented and the prior art are such that the subject matter as a
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`whole would have been obvious at the time the invention was made to a
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`person having ordinary skill in the art to which the subject matter pertains.
`
`19.
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`I have also been advised that several factual inquiries underlie a
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`determination of obviousness. These inquiries include the scope and content
`
`of the prior art, the level of ordinary skill in the field of the invention, the
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`differences between the claimed invention and the prior art, and any
`
`objective evidence of non-obviousness to the extent it exists.
`
`20.
`
`I understand that obviousness can be established by combining or modifying
`
`the teachings of the prior art to achieve the claimed invention. It is also my
`
`understanding that where there is a reason to modify or combine the prior art
`
`to achieve the claimed invention, there must also be a reasonable expectation
`
`of success for a finding of obviousness.
`
`21.
`
`I understand that a claimed invention may be obvious if some teaching,
`
`suggestion, or motivation that would have led a person of ordinary skill in
`
`the art to combine the invalidating references exists. I also understand that
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`this suggestion or motivation may come from such sources as explicit
`
`statements in the prior art or from the knowledge of one of ordinary skill in
`
`the art. Alternatively, any need or problem known in the field at the time
`
`and addressed by the patent may provide a reason for combining elements of
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`the prior art.
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`22.
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`I also understand that the law requires a “common sense” approach of
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`examining whether the claimed invention is obvious to a person of ordinary
`
`skill in the art. For example, I understand that combining familiar
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`limitations according to known methods is likely to be obvious when it does
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`no more than yield predictable results. I have been advised that when there
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`is a design need or market pressure and a finite number of predictable
`
`solutions, a person of ordinary skill may be motivated to apply his or her
`
`skill and common sense in trying to combine the known options in order to
`
`solve the problem.
`
`23.
`
`It is also my understanding that one way to rebut a finding of obviousness is
`
`to present evidence of secondary considerations of nonobviousness, such as
`
`unexpected results, commercial success, long felt but unsolved need, and the
`
`failure of others to achieve the claimed invention. I also understand that, in
`
`order to be relevant to the issue of obviousness, such secondary indicia must
`
`have some connection (or nexus) to the claimed invention.
`
`24.
`
`I have followed these principles in my analysis below.
`
`VII. Person of Ordinary Skill in the Art
`
`25. The ’919 patent is a U.S. nonprovisional application that was filed on
`
`November 2, 2001. In my opinion, 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
`
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`medical physics or a related field (e.g., physics or engineering), and three
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`years of work in physics, engineering, or radiation oncology beyond the
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`completion of his or her degree.
`
`VIII. Technology Background: Radiation Therapy
`
`26. The ’919 patent is not the first reference to disclose a radiation therapy
`
`machine having an “articulable” imager. As described here in my
`
`declaration, radiation therapy machines having adjustable diagnostic imagers
`
`and sources have long been known in the radiation therapy field. By
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`November 2000 (a year before the ’919 patent was first filed), it was well
`
`known in the radiation therapy industry for machines to have radiation
`
`sources and imagers that could be articulated into different positions, while
`
`also able to be rotated around a patient. The following discussion of the
`
`prior art supports this conclusion.
`
`A. Radiation Treatment Machines
`27. By the 1990s, linear accelerators were the dominant type of radiotherapy
`
`machine for cancer treatment. A linear accelerator (or “linac”) generates a
`
`source of high-energy radiation for the treatment of patients. It outputs a
`
`beam having a controlled amount of radiation (electrons or x-rays) in the
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`energy range of ~4 to ~25 MeV, the so-called megavoltage (or MV) x-ray
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`range. Ex. 1001 at 4:33-36. A typical linac is mounted on a gantry and
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`rotates the radiation source, and thus the beam, around a rotational axis
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`extending in a horizontal direction. A patient table (or couch) supports the
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`patient lying down along this horizontal axis.
`
`28. During therapy, a patient is positioned on the couch so that the specified
`
`target volume (e.g., a tumor) to be irradiated is geometrically known with
`
`respect to the beam’s isocenter. 1 In the majority of cases, the beam
`
`irradiates the tumor at various angles during rotation. An objective of
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`radiation therapy is to irradiate target tissue to a prescribed total absorbed
`
`dose while minimizing radiation delivered to healthy tissue and critical
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`structures (e.g., spinal cord). See Carlos A. Perez et al., Overview, in
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`PRINCIPLES AND PRACTICE OF RADIATION ONCOLOGY 2-3 (Carlos A. Perez &
`
`Luther W. Brady eds., 3d ed. 1998).
`
`29. Prior to therapy, a dosimetrist or medical physicist will create a computer
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`“treatment plan” that defines the set of instructions used by the treatment
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`machine to deliver the radiation to the target. The goal of this treatment plan
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`will be to irradiate the cancerous target tissue while minimizing the amount
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`of radiation delivered to healthy tissue. The treatment plan will thus define
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`the type and energy of the beam, the directions (or rotational angles) at
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`1 In Fig. 1A of the ’919 patent, the isocenter is shown as the “pivot axis.”
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`which the machine generates a beam, as well as the shape of the beam and
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`the radiation dose at each direction (or rotational angle). Other technical
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`details are also specified by the treatment plan such as dose rate, use of
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`wedges, blocks, etc. Ex. 1011 at 3-4, 286-288.
`
`30. Radiation therapy simulators have been used in treatment planning to mimic
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`the movement of radiation therapy machines since at least 1993. James A.
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`Purdy, Principles of Radiologic Physics, Dosimetry, and Treatment
`
`Planning, in PRINCIPLES AND PRACTICE OF RADIATION ONCOLOGY 259-60
`
`(Carlos A. Perez & Luther W. Brady eds., 3d ed. 1998). Fig. 8-29 shows an
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`example of a simulator with components that are adjustable in multiple
`
`directions. Id. For example, the image intensifier can rotate (A) and/or
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`move laterally (D), longitudinally (E), radially (F). Id. The radiation source
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`can similarly rotate (A), alter the source distance (B), and/or rotate the
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`collimator (C). Id.
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`31. Fig. 1(b) of Jaffray Article (Ex. 1010 at 775) (annotated version reproduced
`
`below) shows an example of a radiation treatment machine having a
`
`diagnostic imager. A diagnostic imager typically receives radiation from a
`
`kilovoltage (kV) source emitting x-rays in the diagnostic energy range of
`
`~50 to ~125 keV, the so-called kilovoltage (or kV) x-ray range. Ex. 1001 at
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`1:53-57.
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`Direction
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`Rotation
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`Arm
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`
`
`supporting
`kV x-ray tube
`
`Arm
`
`supporting
`
`MV imager
`
`supporting
`kV imager
`
`Arm
`
`Am
`
`supporting
`1 MV source
`Arm
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`32.
`
`The treatment machine shown in Jaflray Article is similar, if not identical, to
`
`the machine shown in Fig. 1A (reproduced below) of the ’919 patent, which
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`the ’919 patent recognizes as prior art.
`
`FIG. 1A
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`(Prior Art)
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`33. Both Fig. 1(b) of Jaffray Article and Fig. 1A of the ’919 patent show that the
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`above type of radiation treatment machine has a therapeutic (or “MV”)
`
`radiation source and a diagnostic (or “kV”) radiation source. Each source is
`
`mounted on an arm. Ex. 1001 at 2:19-32; Ex. 1010 at 773. Each source also
`
`has a corresponding imager that is also mounted on a corresponding arm.
`
`Ex. 1001 at 2:19-32; Ex. 1010 at 773. The machine rotates these sources
`
`and imagers around a horizontal axis corresponding to the machine’s
`
`isocenter. Ex. 1001 at 2:19-32, 2:47-50, Fig. 1A; Ex. 1010 at 773-75.
`
`34. While the ’919 patent does not describe that the arms attached to the
`
`diagnostic imager or source in Fig. 1A could allow for additional articulation
`
`or extension of the respective imager or source, it was well-known for
`
`radiation treatment machines to have mechanisms that allowed this. For
`
`instance, Jaffray Article itself explains that the arm attaching the kV x-ray
`
`tube to the drum was “retractable,” such that the tubular arms could “retract
`
`[the kV source] into the accelerator’s drum structure.” Ex. 1010 at 774.
`
`35. Fig. 1B (annotated and reproduced below) of the ’919 patent illustrates
`
`another variation of a radiation therapy machine having diagnostic imagers.
`
`As shown below, Fig. 1B discloses a therapeutic radiation source attached to
`
`a first gantry, two diagnostic radiation sources attached to the first gantry by
`
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`two separate gantries (arms), and two imagers attached to the first gantry by
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`two other arms gantries (arms). Ex. 1001 at 2:33-43.
`
`lherapeutic radiation source
`
`Arm
`
`second diagnostic
`radiation source
`
`P
`
`filst diagnostic imager
`Arm
`
`,
`
`‘
`
`second diagnostic Imager
`Arm
`
`FIG. 1 B
`
`(Prior Art)
`
`36. Again, the ’919 patent does not explain that any of the diagnostic imagers or
`
`sources shown in Fig. 1B were “articulable” or “extendable” in some way
`
`(e.g., for alignment purposes,
`
`for calibration purposes, or for enabling
`
`different clinical applications). As described in the sections below, however,
`
`it was well known at the time for radiation treatment machines to have
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`mechanisms that allowed the diagnostic imagers, as well as the diagnostic
`
`sources, to be articulable or extendable.
`
`1.
`37. A patient typically receives radiation therapy on a daily basis over a period
`
`Patient Imaging
`
`ranging from one day to several weeks, depending on the diagnosis.
`
`Generally the therapy uses the same treatment plan for multiple daily
`
`fractions. Therefore, a major concern is the ability to reliably reposition the
`
`patient to conform to the computer treatment plan with respect to geometry.
`
`If the patient is not positioned correctly, then the tumor will not receive the
`
`full dose of radiation desired by the treatment plan. This not only
`
`compromises the treatment, but can also cause other complications by
`
`overdosing healthy tissue and critical organs. See Ex. 1001 at 1:13-39; Ex.
`
`1014 at 1:20-2:12; Ex. 1007 at 381; Ex. 1011 at 2-3.
`
`38. Radiation therapy machines thus have on-board imagers to determine the
`
`location of the tumor and help accurately position the patient. As described
`
`above, Figs. 1A and 1B of the ’919 patent illustrate a few variations of prior
`
`art machines having on-board “therapeutic imagers” and “diagnostic
`
`imagers” used to image the patient during the positioning process. Ex. 1001
`
`at 2:19-43.
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`39. As mentioned above, the imaging can be done by using two different types
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`of x-ray sources: (1) a kilovoltage (kV) source, or (2) a megavoltage (MV)
`
`source. The ’919 patent refers to the former as a “diagnostic” source and the
`
`latter as “therapeutic” source. Ex. 1001 at 2:27-33. These sources have
`
`important differences when it comes to imaging. A radiographic image
`
`created by a kV source provides greater contrast between soft tissue and
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`bone. Id. at 1:57-62. This occurs because the relative absorption of kV x-
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`rays in bone compared to soft tissue is much greater than for MV x-rays.
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`40.
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`I summarize below the use of therapeutic MV imagers and the use of
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`diagnostic kV imagers.
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`a)
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`Therapeutic (“MV” or “Portal”) Imagers
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`41. As explained above, the radiation therapy machine must position a patient in
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`the correct orientation, such that the patient’s tumor is precisely aligned.
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`Initially, this was done using “portal” images. Portal images are those
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`created based on radiation from the MV treatment beam. Because portal
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`imagers do not allow for good imaging of soft tissue, radiation treatment
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`machines have been enhanced over the years to include kV imaging, which
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`has better quality images for improved treatment accuracy.
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`42. With portal imaging, when positioning a patient for treatment, a standard
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`procedure would be to compare the portal image to an earlier kV image of
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`the patient obtained during the treatment planning phase. These earlier kV
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`images indicated the location of the target volume (e.g., the patient’s tumor)
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`relative to the isocenter of the treatment machine. The portal images, taken
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`during a therapy session, were then compared (e.g., by the trained eye of the
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`radiation oncologist) to the earlier images to determine if the target area was
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`in the correct location. If the target area was not in the correct location, then
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`the patient was moved. This would typically be done by moving the motor-
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`controlled couch.
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`43. By the 1990s, it was common practice to use portal imagers. The portal
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`imager was mounted directly opposite the radiation source. With this setup,
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`the radiation beam passes through the patient at the isocenter and then is
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`captured by the portal imager. Examples of a portal imaging device on a
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`linear accelerator are shown in Figs. 1A and 1B of the ’919 patent and also
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`in the figure below.
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`Ex. 1006 (Munro) at 119.
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`44.
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`Because the MV therapeutic imager was coupled to the same rotatable
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`component that supported the MV treatment source, the MV imager would
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`rotate around the patient as the treatment source itself rotated around the
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`patient. For example, Figs. 1(a) and l(b) of Jaflray ’502 (reproduced here),
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`illustrates how the MV imager would rotate around the patient on the
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`opposite side of the MV radiation source. The MV imager would thus
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`follow a path as it was rotated along an are around the patient. A clinician
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`would thus need to be careful that the MV imager would not collide with
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`other equipment or persons in the path of the rotating imager. Fig. 1A of the
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`’9l9 patent (annotated below) illustrates the path that the diagnostic imager
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`and source would follow during rotation.
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`diagnostic X-ray source
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`sew Path of imagers_
`..---z.~/
`and sources during
`rotation
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`'
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`FIG. 1A
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`(Prior Art)
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`b)
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`Diagnostic (or “kV”) Imagers
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`45-
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`As discussed previously, diagnostic imagers use a kV radiation source to
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`image a patient. By the early 1990s, many radiation therapy machines also
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`included diagnostic imagers. Figs. 1A and 1B of the ’919 patent show
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`examples of prior art machines having a diagnostic radiation source and
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`diagnostic imager. Because the diagnostic radiation source and imager were
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`mounted to the machine itself,
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`they could be positioned to essentially
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`duplicate the same position of the MV radiation source. Ex. 1001 at 2:19-
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`60.
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`46-
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`As explained above, it was known by November 2000 to use diagnostic
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`imagers to help accurately position the patient prior to treatment. It was also
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`well known to use diagnostic imagers to obtain a computed tomography
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`(CT) scan of the patient. A CT scan is acquired by placing the patient on the
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`couch and rotating the diagnostic radiation source around the patient.
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`Multiple two-dimensional (2-D) images are then acquired from different
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`rotational angles. Computer processing techniques then combine these 2-D
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`images to produce a 3-D or volumetric image of the patient, including the
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`patient’s target volume. Such CT images can then be used to position the
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`patient’s such that the target volume is correct with respect to the isocenter.
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`47. There were thus various reasons to include diagnostic imagers on a radiation
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`treatment device. Of course, by including both a diagnostic imager and a
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`diagnostic source on treatment machine increases the number of components
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`on that machine and the number of components rotating around the patient.
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`48. Diagnostic imagers and diagnostic radiation sources are expensive pieces of
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`equipment. The cost of the hardware alone can cost tens of thousands of
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`dollars. They are also extremely sensitive. If a patient or another piece of
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`equipment were to collide with the imager or radiation source, then the
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`imager or source could be easily damaged.
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`2.
`49. By November 2000, it was well known to have mechanisms to adjust the
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`Prior Mechanisms for Positioning Imagers and Sources
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`position or location of the imaging components on a radiation treatment
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`machine. There were many reasons for this.
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`50. First, clinicians often desired the ability to fold these components into a
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`storage position when not in use. Doing so moved the kV imager, kV
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`source, or both out of the way so neither component would collide with
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`other equipment, a clinician, or the patient, either during rotation or while
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`the machine was stationary. See, e.g., Ex. 1010 at 774; Ex. 1006 at 120-121,
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`123. It was thus known to adjust the position of the imager or source during
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`rotation in order to avoid rotation-induced collisions of these components
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`with the patient or treatment couch.
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`51. Second, clinicians often wanted to move these components out of the way
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`for ease or comfort of the patient. Many cancer patients have difficulty
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`moving or positioning themselves on the treatment couch. If a radiation
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`treatment machine, such as the one shown in Fig. 1A of the ’919 patent, has
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`components on all four sides of the patient, then it would be typical (if not
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`necessary) to allow these components to swivel out of the way. For
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`example, if the arm supporting the kV diagnostic imager of Fig. 1A had a
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`hinge that allowed the imager to be swiveled away from the couch, then that
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`may make it easier for the patient to get on or off the treatment couch. It
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`may also make it easier for the clinician to reach the patient during the
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`treatment procedure.
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`52. Third, clinicians often desired the ability to reposition the imager or source
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`relative to one another or a person or object in order to use it for different
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`types of applications or patients. For instance, a smaller patient (e.g., a
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`child) may require that the diagnostic imager and source be closer together,
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`while a larger adult may require the opposite. As another example,
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`clinicians typically adjusted the relative distance or orientation between the
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`imager and source to achieve a desired field of view for imaging.
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`53. Fourth, some diagnostic imagers and sources required at least some degree
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`of adjustability during installation. As the ’919 patent recognizes, a
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`diagnostic imager would not work properly if it was not accurately aligned
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`with its corresponding radiation source. Therefore, during installation, the
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`radiation treatment machine would need to allow some adjustment of the
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`position of the imager or source.
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`54.
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`I summarize below a few prior art references illustrating some of the known
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`mechanisms that allowed the position or location of an imager or radiati