United States Patent No. 6,888,919
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`––––––––––
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`––––––––––
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`ELEKTA INC.
`Petitioner
`v.
`
`VARIAN MEDICAL SYSTEMS, INC.
`Patent Owner
`
`––––––––––
`
`Case IPR2016-01902
`Patent No. 6,888,919
`
`––––––––––
`
`PATENT OWNER’S PRELIMINARY RESPONSE.
`
`
`
`
`
`
`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`––––––––––
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`––––––––––
`
`ELEKTA INC.
`Petitioner
`v.
`
`VARIAN MEDICAL SYSTEMS, INC.
`Patent Owner
`
`––––––––––
`
`Case IPR2016-01902
`Patent No. 6,888,919
`
`––––––––––
`
`PATENT OWNER’S PRELIMINARY RESPONSE.
`
`
`
`
`
`
`
`United States Patent No. 6,888,919
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`
`TABLE OF CONTENTS
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`
`
`Page
`
`PETITIONER’S LIST OF EXHIBITS ................................................................. i
`I.
`INTRODUCTION ..................................................................................... 1
`II.
`OVERVIEW OF THE ’919 PATENT ...................................................... 1
`A.
`State of the Art ............................................................................... 1
`
`B.
`
`Subject Matter of the ’919 Patent ................................................ 12
`
`III. CLAIM CONSTRUCTION .................................................................... 18
`A.
`Level of Skill in the Art ............................................................... 19
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`Legal Standard ............................................................................. 20
`
`“gantry” ........................................................................................ 21
`
`“a second gantry that is rotatable” ............................................... 25
`
`“articulable end [of the second gantry]” ...................................... 29
`
`“extending and retracting [the second radiation source]” ........... 31
`
`SHOWN A REASONABLE
`IV. PETITIONER HAS NOT
`LIKELIHOOD THAT AT LEAST ONE CLAIM OF THE ’919
`PATENT IS UNPATENTABLE ............................................................ 34
`Legal Standard ............................................................................. 34
`
`A.
`
`B.
`
`C.
`
`Claims 1-4, 9, 11, and 13 are Not Obvious Over Barnea in
`View of Watanabe. ...................................................................... 38
`
`Petitioner Has Failed to Show that Grady Anticipates Claim
`13. ................................................................................................ 60
`
`V.
`
`CONCLUSION ....................................................................................... 68
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`-i-
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`United States Patent No. 6,888,919
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`
`TABLE OF AUTHORITIES
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`
`
`
`
`Page(s)
`
`CASES
`ActiveVideo Networks v. Verizon Commc’ns, Inc.,
`694 F.3d 1312 (Fed. Cir. 2012) .......................................................................... 36
`
`Bell Atl. Network Servs. v. Covad Commc’ns Grp.,
`262 F.3d 1258 (Fed. Cir. 2001) .......................................................................... 20
`
`CBS Interactive Inc. v. Helferich Patent Licensing, LLC,
`Case IPR2013-00033, Paper 122 (P.T.A.B. Mar. 3, 2014) ................................ 20
`
`Dominion Dealer Solutions, LLC v. AutoAlert, Inc.
`Case IPR2013-00220, Paper 9 (P.T.A.B. Aug 15, 2013) ................. 35, 36, 37, 57
`
`Ex Parte Hindle,
`Appeal 2012-003332 (P.T.A.B. July 17, 2014) .................................................. 35
`
`Gordon * Howard Assocs., Inc. v. LunarEye, Inc.,
`Case IPR2014-00712, Paper 8 (P.T.A.B. Oct. 17, 2014) ................................... 19
`
`In re Fine,
`837 F.2d 1071 (Fed. Cir. 1988) .......................................................................... 35
`
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) .......................................................... 37, 42, 51, 53
`
`In re Hyatt,
`708 F.2d 712 (Fed. Cir. 1983) ............................................................................ 20
`
`In re Morris,
`127 F.3d 1048 (Fed. Cir. 1997) .......................................................................... 19
`
`In re Ratti,
`270 F.2d 810 (CCPA 1959) .................................................................... 37, 42, 51
`
`In re Skvorecz,
`580 F.3d 1262 (Fed. Cir. 2009) .......................................................................... 20
`
`InTouch Technologies, Inc. v. VGO Comm’ns, Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) .......................................................................... 52
`
`-i-
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`United States Patent No. 6,888,919
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`
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`Karsten Mfg. Corp. v. Cleveland Golf Co.,
`242 F.3d 1376 (Fed. Cir. 2001) .......................................................................... 38
`
`Kinetic Techs., Inc. v. Skyworks Solutions, Inc.,
`IPR2014-00529, Paper 8 (P.T.A.B. Sept. 23, 2014)........................................... 36
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ................................................................................ 35, 36, 57
`
`Microsoft Corp. v. Proxyconn, Inc.,
`789 F.3d 1292 (Fed. Cir. 2015) .......................................................................... 20
`
`Net MoneyIN v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) .......................................................................... 37
`
`Nissim Corp. v. Time Warner, Inc.,
`Appeal No. 2011-011260 (B.P.A.I. Feb. 6, 2012) .............................................. 20
`
`Par Pharma, Inc. v. TWI Pharma, Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) .......................................................................... 37
`
`TRW Automotive US LLC v. Manga Elecs. Inc.,
`Case IPR2014-00259, Paper 19 (P.T.A.B. June 26, 2014) .......................... 35, 36
`
`Verdegaal Bros. v. Union Oil Co. of Cal.,
`814 F.2d 628 (Fed. Cir. 1987) ............................................................................ 37
`
`STATUTES
`
`35 U.S.C. § 103(a) ................................................................................................... 35
`
`OTHER AUTHORITIES
`
`37 C.F.R. §§ 42.61, 62, 64 ......................................................................................... 4
`
`37 C.F.R. § 42.64 ....................................................................................................... 5
`
`37 C.F.R. § 42.107 ..................................................................................................... 1
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`M.P.E.P. § 2131 ....................................................................................................... 37
`
`
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`-ii-
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`United States Patent No. 6,888,919
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`
`PETITIONER’S LIST OF EXHIBITS
`
`
`
`Ex.
`
`Description
`
`2001 Declaration of Kenneth Gall
`
`2002 U.S. Patent No. 5,448,607
`
`2003 U.S. Patent No. 6,614,036
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`2004 U.S. Patent No. 5,727,554
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`2005 U.S. Patent No. 5,724,400
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`2006
`
`IEC International Standard 60601-2-1, Second edition, June 1998
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`-i-
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`I.
`
`INTRODUCTION
`
`Patent Owner Varian Medical Systems, Inc. (“Varian”) submits this
`
`Preliminary Response under 37 C.F.R. § 42.107. The Board should not institute
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`inter partes review (IPR) on claims 1-4, 9, 11, and 13 of U.S. Patent No. 6,888,919
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`(the “’919 Patent”) because Petitioner Elekta Inc. (“Elekta” or “Petitioner”) has not
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`shown a reasonable likelihood of prevailing on any of its proposed grounds of
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`unpatentability. Petitioner has failed to show how the proposed Barnea-Watanabe
`
`combination allegedly discloses each and every element of independent claims 1
`
`and 13. Petitioner has also failed to show that a person of ordinary skill in the art
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`would have combined Barnea and Watanabe, relying on a purported motivation to
`
`combine that is based on improper hindsight analysis. Petitioner merely cobbles
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`together independent features from unrelated references and fails to explain or
`
`analyze the rational underpinnings for why one of ordinary skill in the art would
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`have combined such references, when in fact a person would have not been
`
`motivated to combine the references. Further, Petitioner has failed to show that
`
`Grady discloses each and every clement of independent claim 13. For these, and
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`other reasons explained herein, the Board should deny in its entirety the Petition
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`for Inter Partes Review of the ’919 Patent.
`
`II. OVERVIEW OF THE ’919 PATENT
`State of the Art
`A.
`At the time the ’919 Patent was filed, radiation therapy, or radiotherapy, was
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`
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`1
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`
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`
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`a well-practiced method of treatment for cancer patients, using ionizing radiation
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`to kill cancer cells. Ex. 2001, Declaration of Kenneth Gall, at ¶ 47. By 2001, “the
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`use of linear accelerators for the generation of either electron radiation or X-ray
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`radiation [was] well known.” Ex. 1001, ’919 Patent at 1:14-15; see also Ex. 2005
`
`at 1:21-22; Ex. 2001 at ¶ 47. A radiotherapy system was a specialized system that
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`would mount a linear accelerator (“linac”) or other radiation source into a position
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`so that a patient’s tumor would be exposed to the resulting radiation beam. Ex.
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`2001 at ¶ 47; see also Ex. 1012 at 1:15-18. 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; Ex. 2001 at ¶ 47. 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; Ex. 1012 at 1:22-25; Ex. 2001 at ¶
`
`47.
`
`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
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`treatment, or shortly before treatment commenced. Ex. 2001 at ¶ 48. It was
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`important to minimize delays or movement of the patient between determining the
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`location of the tumor and performing treatment. Id. Soft tissues in the human
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`
`
`2
`
`
`
`
`
`body, including organs and tumors, could move over time, including while
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`breathing, during movement, or even just naturally, independent of other factors.
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`See, e.g., Ex. 1001 at 1:30-34, 2:45-47; Ex. 2004 at 1:26-29; Ex. 2001 at ¶ 48.
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`Therefore, too long of a delay between determining the location of the tumor and
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`beginning treatment could result in shifts in the soft tissues. Ex. 2001 at ¶ 48. If
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`the treatment method did not adjust for any movement, the misplacement of the
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`therapeutic radiation could result in the tumor not receiving an effective dose of
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`radiation, and/or healthy tissue of the patient receiving a high dose of radiation. Id.
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`Obtaining diagnostic images of a patient using radiation beams (e.g., X-rays)
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`just prior to performing therapeutic treatment could confirm the position of a tumor
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`within the patient. Id. at ¶ 49. The therapeutic radiation source of a radiotherapy
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`system could theoretically be used for diagnostic imaging; however, the image
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`quality was usually very poor, as the high-energy radiation did not provide as
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`much soft-tissue contrast. See, e.g., Ex. 1001 at 1:40-53; Ex. 2001 at ¶ 49.
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`Therefore, a separate diagnostic radiation source such as a low-energy X-ray could
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`be used for diagnostic imaging as part of the radiotherapy treatment. See, e.g., Ex.
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`1001 at 1:53-67; Ex. 2001 at ¶ 49. In some systems, a diagnostic radiation source
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`could also be used for 3D computerized tomography (CT) scans, which would
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`enable three-dimensional reconstruction of the target volume and surrounding soft
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`tissue. See, e.g., Ex. 1001 at 4:50-58; Ex. 2001 at ¶ 49. A 3D image of the target
`
`
`
`3
`
`
`
`
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`volume could be used for improved treatment planning.
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`In addition to the use of diagnostic imaging to verify the position of the
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`target volume, proper positioning of the therapeutic radiation source with minimal
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`unnecessary movement was desirable. Ex. 2001 at ¶ 50. However, some
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`radiotherapy systems did require at least some movement of components to
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`provide a radiation beam at multiple angles relative to the patient. These systems
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`allowed for concentration of a radiation dose on a target volume within a patient’s
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`body from multiple angles (or even a continuous arc). Ex. 2001 at ¶ 50. At the
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`same 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 radiation at
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`different angles. Ex. 2001 at ¶ 50. A radiotherapy system could provide radiation
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`from multiple angles either by using multiple radiation sources placed around the
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`patient, or by allowing a radiation source to rotate around the patient. See, e.g., Ex.
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`1001 Fig. 1A; Ex. 1010 at 3, Fig. 1.1 In the case of a rotating therapeutic radiation
`
`
`
`1 Varian notes that Petitioner alleges that Exs. 1006-1011 constitute prior art to the
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`’919 Patent. However, Petitioner has failed to authenticate these exhibits or show
`
`that they were publicly available at least by 2001. 37 C.F.R. §§ 42.61, 62, 64.
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`While Varian addresses the teachings of these purported prior art references,
`
`Varian reserves the right to object to these exhibits and to move to exclude these
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`
`
`4
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`
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`
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`source, it was important that any movement of therapeutic radiation sources be
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`performed in a precisely-controlled manner to achieve the benefits of a rotating
`
`therapeutic source, without unnecessary movement adversely affecting placement
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`of the beam. Ex. 2001 at ¶ 50; see Ex. 2005 at 2:23-27 (discussing radiation
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`therapy system in which the movement of the therapeutic source is “constrained to
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`a single plane,” which “provides a number of benefits over” systems that permit
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`additional movement).
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`In some radiotherapy systems, adding some flexibility and movement of
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`particular components (such as a diagnostic X-ray) could offer additional
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`advantages. Ex. 2001 at ¶ 51. The gantry and attached equipment used in many
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`radiotherapy systems weighed several tons and were positioned surrounding the
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`patient, and movement of a particular component could require the movement of
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`the entire system, which could require additional time and energy. Ex. 2001 at ¶
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`51. An example radiotherapy system cited by Petitioner as prior art2 shows at least
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`four components of a rotatable gantry that were adjacent to the patient:
`
`
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`exhibits under 37 C.F.R. § 42.64.
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`2 See supra n. 1.
`
`
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`5
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`
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`Ex. 1010 at 3 (Fig. 1(b)); see also Petition at 7; Ex. 2001 at ¶ 51. In this example,
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`the various components (labeled “MV Source,” “kV Imager,” “kV x-ray tube,” and
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`“MV Imager”) were mounted on a gantry, and the components would rotate in
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`unison around the patient via the drum structure of the gantry against the wall. Ex.
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`2001 at ¶ 51. Allowing some of these components to move relative to the rest of
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`the system in a specific, controlled manner could offer greater flexibility in the
`
`system; however, allowing the components to move freely would have been
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`detrimental to the operation of a radiotherapy system, as explained in detail below.
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`Ex. 2001 at ¶ 51.
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`The speed of a rotating gantry and patient accessibility were considerations
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`in the design of radiotherapy systems. For example, standards for medical
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`electrical equipment set by the International Electrotechnical Commission
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`
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`6
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`
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`(“IEC”)3 required that heavy equipment such as linacs that were used in proximity
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`to patients have a speed limit, to ensure that they could be stopped quickly for
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`safety purposes. Ex. 2006 at 8; Ex. 2001 at ¶ 52. Linacs were typically restricted
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`to a movement speed of approximately one revolution per minute. Id. Another
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`consideration was the ease of access to the patient. While the patient would
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`usually lie on a treatment couch that could then be slid into an operative position, if
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`an emergency or other issue arose while the radiotherapy system was in use, it
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`would have been desirable for the radiation technologist to have quick access to
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`the patient. Ex. 2001 at ¶ 52. Because of the specialized nature of radiotherapy
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`systems, a person of ordinary skill in the art would have generally focused on
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`optimizing the systems for the specific purpose of radiotherapy. Id.
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`Some existing radiotherapy systems prior to the invention of the ’919 Patent
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`included a diagnostic radiation source that could be used for treatment guidance
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`(e.g., by verifying that the therapeutic beam is properly aligned with the target
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`volume). Ex. 2001 at ¶ 53. As discussed in the ’919 Patent (and shown by the
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`prior art asserted by Petitioner), these existing systems featured a gantry that held a
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`
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`3 Compliance with IEC standards was needed for a product to receive a “CE” mark
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`indicating approval for use in Europe. See Ex. 2001 at ¶52, n.1. This standard was
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`publicly available at least by the time of filing the ’919 Patent. Id.
`
`
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`7
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`
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`
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`therapeutic radiation source, a diagnostic radiation source, and at least one imager
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`in a fixed geometric relationship. Id. For example, the prior art system discussed
`
`in Fig. 1A of the ’919 Patent shows a gantry holding a therapeutic radiation source
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`and a diagnostic radiation source, where the sources are fixed at a 90-degree
`
`orientation from each other:
`
`
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`Ex. 1001 at Fig. 1A; Ex. 2001 at ¶ 53.
`
`In radiotherapy systems such as the example Fig. 1A of the ’919 Patent, the
`
`diagnostic source and imager could be used for locating the target volume and
`
`subsequently the therapeutic source and imager could be used for treatment. Ex.
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`2001 at ¶ 54. To accurately verify the image, the diagnostic radiation source was
`
`also used. Ex. 1001 at 1:40-42; Ex. 2001 at ¶ 54. Due to the fixed 90-degree
`
`offset between the diagnostic source and the therapeutic source, there would have
`
`
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`8
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`
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`been a time delay in rotating the diagnostic source into the same relative position
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`to the patient as the therapeutic source had been (due to the 1 revolution/minute
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`FDA standard on the gantry holding the linac). Ex. 2006 at 8; Ex. 2001 at ¶ 54.
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`Therefore, switching from therapeutic to diagnostic sources along the same angle
`
`relative to the patient would have taken a not-insignificant amount of time.
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`Similarly, in the systems such as Fig. 1A of the ’919 Patent, a 3D CT
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`reconstruction using the diagnostic source and imager would have taken additional
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`time, because of the rotation speed limit. Ex. 2006 at 8; Ex. 2001 at ¶ 54. Rotation
`
`of the entire gantry about a patient is demonstrated below with the example of Fig.
`
`1A of the ’919 Patent, where the green beam represents a diagnostic radiation
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`beam and the red beam represents a therapeutic radiation beam along the same
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`angle:
`
`Ex. 2001 at ¶54.
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`In the fields of radiotherapy and radiation-based imaging, a motivation to
`
`combine existing systems did not arise simply because a person of ordinary skill in
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`9
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`
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`the art would have been aware of the existing systems. Ex. 2001 at ¶ 55. There
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`were a number of different configurations for a radiotherapy system by 2001,
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`including different configurations of a gantry holding one or more of therapeutic
`
`radiation sources, diagnostic radiation sources, and/or imagers. See, e.g., Ex.
`
`1012; Ex. 1010; Ex. 2003; Ex. 2004; Ex. 2001 at ¶ 55. There were also fields
`
`outside of radiotherapy that used similar equipment, such as clinical X-ray devices,
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`specialized X-ray devices such as mammographic X-ray equipment, dental extra-
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`oral or intra-oral X-ray devices, light ion beam therapeutic equipment, etc. See,
`
`e.g., Ex. 1004; Ex. 2001 at ¶ 55.
`
`While a person of ordinary skill in the art would have been aware of these
`
`systems, such a person would not have thought to simply combine any two or
`
`more systems or references absent an actual motivation for the specific
`
`combination. Ex. 2001 at ¶ 55. This is because such combinations would have
`
`reduced the efficiency of the overall system or even resulted in an inoperable
`
`system in many cases. Id. In particular, any combination of systems or references
`
`that could not adjust or affix the spatial relationship between its components would
`
`not be useful in radiotherapy applications, as Petitioner’s own evidence shows.
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`See, e.g., Ex. 1012 at 6:9-13 (“[g]iven the position of the various components, a
`
`fixed geometrical relationship exists that permits the direct construction of
`
`verification images for immediate use during treatment”); id. at 4:45-48 (“the
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`
`
`10
`
`
`
`
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`target can be irradiated from the same point either with a treatment beam or an x-
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`ray beam, with every other variable remaining unchanged”); Ex. 2001 at ¶ 55.
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`As an example, there were many diagnostic systems such as X-ray
`
`radiography systems that could be positioned in a variety of ways around a target.
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`Ex. 2001 at ¶ 55. The X-ray system could be used to image the patient and detect
`
`objects such as broken bones, damage to or inflammation of soft tissue,
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`cardiovascular issues, etc. Id. However, this type of X-ray system would not be
`
`useful for performing radiotherapy unless the radiotherapist could ensure that the
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`therapeutic beam would hit the target volume exactly where the X-ray diagnostic
`
`system said it was. See, e.g., Ex. 1012 at 1:31-34; Ex. 2001 at ¶ 55. This
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`consideration required that the multiple components of a radiotherapy system be
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`precisely aligned with respect to each other; that is, the mechanical alignment of
`
`the diagnostic source and the therapeutic source relative to each other had to be
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`known and accounted for throughout the procedure. Ex. 2001 at ¶ 55.
`
`A person of ordinary skill in the art would not have used the diagnostic X-
`
`ray attached to a therapeutic radiation source simply for any clinical application -
`
`in any setting where a radiotherapy system is available (e.g., a hospital), there
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`would have been other dedicated diagnostic X-ray systems available for the “wide
`
`range of clinical applications.” Ex. 2001 at ¶ 56. Such a proposed combination
`
`would only make sense in hindsight if a person were to try to combine elements in
`
`
`
`11
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`
`
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`the prior art given a roadmap provided by a patent claim, which is what Petitioner
`
`appears to be doing with its arguments in this case and specifically not allowed
`
`under the case law.
`
`Subject Matter of the ’919 Patent
`
`B.
`The ’919 Patent is directed to a radiotherapy device with an integrated
`
`diagnostic imaging system for directing treatment delivered via a therapeutic
`
`radiation beam. See Ex. 1001 at 2:65-3:2; Ex. 2001 at ¶ 57. In particular, the
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`radiotherapy device design taught by the ’919 Patent allows for a greater range of
`
`beneficial motion for the radiotherapy device (without introducing extraneous
`
`degrees of freedom for the components to move), more flexible workflows, and
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`ensures accurate treatment. See Ex. 1001 at 3:11-27; Ex. 2001 at ¶ 57.
`
`The ’919 Patent discloses a system with a high-energy radiation source for
`
`delivering therapeutic radiation in the megaelectronvolt (“MV”) energy range to a
`
`target volume. See Ex. 1001 at 4:28-36; Ex. 2001 at ¶ 58. One of the radiotherapy
`
`devices described in the ’919 Patent also includes a low-energy X-ray source in the
`
`kiloelectronvolt (“kV”) energy range that can be used for diagnostic purposes and
`
`verification. See Ex. 1001 at 4:40-49; Ex. 2001 at ¶ 58. While the therapeutic MV
`
`source is attached to a first gantry of the device described in the ’919 Patent, an
`
`imager is attached to a second gantry of the device. Ex. 2001 at ¶ 58. By placing
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`the therapeutic source and the imager on separate, independent structures, the
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`
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`12
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`
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`imager can be moved or rotated without requiring the same movement by the
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`therapeutic source. Id. This means that the rotation of the imager is not forced to
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`adhere to the restrictions in the industry standard applicable to the rotation of
`
`therapeutic radiation sources. Ex. 2006 at 8; Ex. 2001 at ¶ 58. In particular
`
`embodiments of the ’919 Patent, the diagnostic radiation source is also attached to
`
`the second gantry. Figure 3A (annotated here) shows the various components of
`
`this embodiment of the invention:
`
`
`
`Ex. 2001 at ¶ 58.
`
`Using a separate, second gantry for the imager offered several benefits.
`
`Because the separate second gantry does not have to move with a linac attached,
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`the second gantry is not as limited with respect to the speed of rotation. Ex. 2001
`
`at ¶ 59. In particular, if the second gantry holds a diagnostic radiation source and
`
`imager, a 3D CT scan could be performed much faster than the example system of
`
`
`
`13
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`
`
`
`
`Fig. 1A of the ’919 Patent, where any such scans would have required rotation of
`
`the single gantry. Id.
`
`Due to the nature of radiotherapy systems and the need for precision and
`
`accuracy, the ’919 Patent describes the various components of the described
`
`system and the respective ranges of motion with specific terms and limits. First,
`
`with respect to the second gantry, the second gantry itself must be able to rotate
`
`around the target volume of the patient. Ex. 2001 at ¶ 60. The rotating movement
`
`of the second gantry is independent of the first gantry; that is, a “rotatable” second
`
`gantry can rotate without a corresponding rotation by the first gantry. See Ex.
`
`1001 at 5:17-18; Ex. 2001 at ¶ 60. This is useful where a diagnostic source is
`
`attached to the second gantry: diagnostic imaging of the target volume could be
`
`performed through positioning and movement of the second gantry alone, without
`
`requiring any movement by the first gantry. Ex. 2001 at ¶ 60. Because the
`
`diagnostic imaging can be performed through an independent structure from the
`
`therapeutic radiation source, “[t]he application of therapeutic radiation and
`
`diagnostic radiation can alternate in any combination to provide diagnostic
`
`imaging and verification imaging as a result of the degrees of freedom available to
`
`position the [imager].” Ex. 1001 at 3:23-27; Ex. 2001 at ¶ 60.
`
`Annotated Figs 3B-3C of the ’919 Patent below show a rotatable second
`
`gantry that is independent of the first gantry holding the therapeutic radiation
`
`
`
`14
`
`
`
`
`
`source:
`
`
`
`The rotation of the second gantry occurs in the same plane and about the same axis
`
`as the therapeutic radiation source, ensuring greater mechanical alignment of the
`
`two systems, which reduces the chances of errors in aligning the therapeutic beam.
`
`Ex. 2001 at ¶ 61.
`
`The ’919 Patent further recites that the second gantry has an “articulable
`
`end” that is attached to the imager. While the word “articulable” can have a
`
`general meaning, the ’919 Patent provides a specific definition, to distinguish the
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`“articulation” of a second gantry from its rotation as discussed above. Ex. 2001 at
`
`¶ 62. In the ’919 Patent, “articulable” indicates that the imager placed on the
`
`articulable end of the second gantry can be “moved in and out of an operative
`
`position through pivoting.” Id. The specification of the ’919 Patent describes how
`
`the articulable arm is used:
`
`The inner arm end 220 attached to the multiple-energy imaging unit
`212 can articulate the multiple-energy imaging unit 212 into
`alignment with either radiation source 202 or 204 . . . . The
`articulating end 220 can be attached to an opposite end 200 of the
`second gantry C-arm 208 to hold and position the multiple-energy
`imaging unit 212 . . . . The articulating end 220 can contain any
`
`
`
`15
`
`
`
`
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`number of pivot points from single plane pivots to ball joints having
`360 degrees of rotation for positioning the multiple-energy imaging
`unit . . . . Further, the articulating end 220 can retract to position the
`multiple-energy imaging unit 212 into a stowed position.
`
`Ex. 1001 at 5:27-30, 5:55-58, 5:61-64, 6:4-6 (emphasis added).
`
` Thus,
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`“articulable” refers specifically to the type of movement that moves the imager in
`
`and out of the operative position, as demonstrated below with the example of Fig.
`
`3B:
`
`
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`Ex. 1001 at Fig. 3B; Ex. 2001 at ¶ 62.
`
`The ’919 Patent also provides a specific definition for how the second
`
`gantry can extend and retract the diagnostic radiation source in embodiments
`
`where the diagnostic radiation source is attached to the second gantry. Ex. 2001 at
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`¶ 63. Again, “extend” and “retract” do not refer to movement in any direction, but
`
`rather refer to the movement of the diagnostic (e.g., “second”) radiation source in
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`and out of an operative position, as the example embodiment of Fig. 3B
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`demonstrates:
`
`
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`16
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`
`
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`
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`Ex. 1001 at Fig. 3B; Ex. 2001 at ¶ 63.
`
`The ’919 Patent thus allows for specific flexibility of the radiotherapy
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`system’s components. That is, the system of the ’919 Patent does not simply allow
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`each of its components (e.g. the therapeutic radiation source, the diagnostic
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`radiation source, and at least one imager) to have degrees of freedom for the sake
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`of adding flexibility. Ex. 2001 at ¶ 64. As discussed supra, the system of the
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`’919 Patent includes specific movements of each component that provide a
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`particular benefit, and not just any type of motion. Id.
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`One of the advantages of the inventive system of the ’919 Patent is that the
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`flexibility of the system allows for the diagnostic imaging to occur from particular
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`angles, then for therapeutic radiation to be delivered to the target volume from
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`substantially similar angles. Ex. 2001 at ¶ 65. The flexibility that is permitted in
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`the ’919 Patent specifically permits the diagnostic system to be moved to avoid
`
`interference. Id. Because the diagnostic radiation source and the therapeutic
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`radiation source can be aligned on the same plane and can move out of the plane
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`when the diagnostic source is retracted (e.g. not in use), this system is flexible
`
`
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`17
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`
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`where needed, and immobile where a fixed angle is needed. Id.
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`Claims 1 and 13 are the independent claims challenged by Petitioner:
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`1. An apparatus comprising:
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`a first therapeutic radiation source attached to a first gantry;
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`at least one second radiation source;
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`a second gantry that is rotatable, the second gantry is attached
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`to the first gantry; and
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`an imager attached to an articulable end of the second gantry.
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`13. An apparatus comprising:
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`a first radiation source attached to a first gantry;
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`at least one second radiation source;
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`a second gantry that is rotatable, wherein the second gantry is
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`capable of extending and retracting the second radiation source
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`attached to the second gantry; and
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`an imager attached to an articulable end of the second gantry.
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`III. CLAIM CONSTRUCTION
`As will be described below, Petitioner has failed to demonstrate a reasonable
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`likelihood that any of the challenged claims are unpatentable, even if the Board
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`adopts Petitioner’s constructions. Varian however disagrees with Petitioner’s
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`constructions and provides the following responses to Petitioner’s proposed
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`
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`18
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`
`
`
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`constructions. Varian reserves the right to offer constructions for additional terms,
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`should those terms become relevant to either this or other proceedings. Varian
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`also reserves the right to offer claim constructions in other proceedings, including
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`district court litigation, that differ from those presented in this Preliminary
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`Response. See Gordon * Howard Assocs., Inc. v. LunarEye, Inc., Case IPR2014-
`
`00712, Paper 8, at *7 (P.T.A.B. Oct. 17, 2014) (“The standard for claim
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`construction in a district court infringement action is different than the standard
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`applied by the Board.” (citing In re Morris, 127 F.3d 1048, 1053-54 (Fed. Cir.
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`1997)).
`
`A. Level of Skill in the Art
`Petitioner states that a person of ordinary skill in the art at the time the ’919
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`Patent was filed 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 years of
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`work in physics, engineering, or radiation oncology beyond the completion of his
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`or her degree.” Pet. at 17. Petitioner appears to overestimate the level of skill of a
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`person of ordinary skill in the art in an effort to make the obviousness challenges
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`easier. Ex. 2001 at ¶ 46. A person of ordinary skill in the art for the ’919 Patent
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`would have had a post-graduate degree in physics or engineering, with significant
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`exposure to the principles of radiation generation and deposition in human
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`subjects, or at least two years of experience in the field of radiotherapy with at
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`19
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`least a Bachelor of Science degree in mechanical engineering, ap
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