United States Patent No. 6,888,919
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`––––––––––
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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 IPR2016-01904
`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 IPR2016-01904
`Patent No. 6,888,919
`
`––––––––––
`
`PATENT OWNER’S PRELIMINARY RESPONSE.
`
`
`
`
`
`
`
`United States Patent No. 6,888,919
`
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`
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`TABLE OF CONTENTS
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`Page
`PETITIONER’S LIST OF EXHIBITS .......................................................................... v
`
`I.
`
`II.
`
`INTRODUCTION ............................................................................................... 1
`
`OVERVIEW OF THE ’919 PATENT ................................................................ 1
`
`A.
`
`B.
`
`State of the Art ............................................................................... 1
`
`Subject Matter of the ’919 Patent ................................................ 11
`
`III. CLAIM CONSTRUCTION .............................................................................. 17
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`Level of Skill in the Art ............................................................... 17
`
`Legal Standard ............................................................................. 18
`
`“gantry” ........................................................................................ 19
`
`“a second gantry that is rotatable” ............................................... 23
`
`“articulable end [of the second gantry]” ...................................... 27
`
`“extending and retracting [the second radiation source]” ........... 29
`
`IV. PETITIONER HAS NOT SHOWN A REASONABLE LIKELIHOOD
`THAT AT LEAST ONE CLAIM OF THE
`’919 PATENT
`IS
`UNPATENTABLE ............................................................................................ 32
`A.
`Legal Standard ............................................................................. 32
`
`B.
`
`C.
`
`D.
`
`Claims 1, 3, 4, 9, and 11 are not Anticipated by Jaffray ’502. .... 36
`
`The Challenged Claims are Not Obvious Over Jaffray ’502 in
`View of Watanabe. ...................................................................... 49
`
`Ground III is Redundant. ............................................................. 70
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`-i-
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`United States Patent No. 6,888,919
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`E.
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`There is No Motivation to Combine Jaffray ’502 and
`Watanabe with Maschke. ............................................................. 72
`
`V.
`
`CONCLUSION .................................................................................................. 74
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`
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`-ii-
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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) .......................................................................... 35
`
`Bell Atl. Network Servs. v. Covad Commc’ns Grp.,
`262 F.3d 1258 (Fed. Cir. 2001) .......................................................................... 19
`
`CBS Interactive Inc. v. Helferich Patent Licensing, LLC,
`Case IPR2013-00033, Paper 122 (P.T.A.B. Mar. 3, 2014) ................................ 19
`
`Dominion Dealer Solutions, LLC v. AutoAlert, Inc.,
`Case IPR2013-00220 (JL), Paper 9 (P.T.A.B Aug. 15, 2013) ..................... 33, 34
`
`Ex Parte Hindle,
`Appeal 2012-003332 (P.T.A.B. July 17, 2014) .................................................. 33
`
`Gordon * Howard Assocs., Inc. v. LunarEye, Inc.,
`Case IPR2014-00712, Paper 8 (P.T.A.B. Oct. 17, 2014) ................................... 17
`
`In re Fine,
`837 F.2d 1071 (Fed. Cir. 1988) .......................................................................... 33
`
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ................................................................ 35, 61, 70
`
`In re Hyatt,
`708 F.2d 712 (Fed. Cir. 1983) ............................................................................ 18
`
`In re Ratti,
`270 F.2d 810 (CCPA 1959) .........................................................................passim
`
`Karsten Mfg. Corp. v. Cleveland Golf Co.,
`242 F.3d 1376 (Fed. Cir. 2001) .......................................................................... 33
`
`Kinetic Techs., Inc. v. Skyworks Solutions, Inc.,
`IPR2014-00529, Paper 8 (P.T.A.B. Sept. 23, 2014)........................................... 35
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 33, 34
`
`-iii-
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`United States Patent No. 6,888,919
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`Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co.,
`CBM2012-00003, Paper 7 (P.T.A.B. Oct. 25, 2012) ................................... 70, 71
`
`Net MoneyIN v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) .......................................................................... 33
`
`Nissim Corp. v. Time Warner, Inc.,
`Appeal No. 2011-011260 (B.P.A.I. Feb. 6, 2012) .............................................. 18
`
`Par Pharma, Inc. v. TWI Pharma, Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) .......................................................................... 35
`
`TRW Automotive US LLC v. Manga Elecs. Inc.,
`Case IPR2014-00259, Paper 19 (P.T.A.B. June 26, 2014) ................................ 34
`
`Verdegaal Bros. v. Union Oil Co. of Cal.,
`814 F.2d 628 (Fed. Cir. 1987) ............................................................................ 32
`
`STATUTES
`
`35 U.S.C. § 103(a) ................................................................................................... 33
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.61 ....................................................................................................... 4
`
`37 C.F.R. § 42.62 ....................................................................................................... 4
`
`37 C.F.R. § 42.64 ....................................................................................................... 4
`
`37 C.F.R. § 42.107 ..................................................................................................... 1
`
`M.P.E.P. § 2131 ....................................................................................................... 32
`
`
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`-iv-
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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
`
`2004 U.S. Patent No. 5,727,554
`
`2005 U.S. Patent No. 5,724,400
`
`2006
`
`IEC International Standard 60601-2-1, Second edition, June 1998
`
`2007 U.S. Patent No. 5,233,990
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`-v-
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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
`
`(the “’919 Patent”) because Petitioner Elekta Inc. (“Elekta” or “Petitioner”) has not
`
`shown a reasonable likelihood of prevailing on any proposed ground. Petitioner
`
`has failed to show that Jaffray ’502 discloses every element of independent claim
`
`13. Further, Petitioner has failed to show how the proposed Jaffray ’502-
`
`Watanabe combination or
`
`the proposed Jaffray
`
`’502-Watanabe-Maschke
`
`combination allegedly discloses every element of the challenged claims. Petitioner
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`has also failed to show that a person of ordinary skill in the art (“POSITA”) would
`
`have combined Jaffray ’502 and Watanabe (and Maschke), relying on a purported
`
`motivation to combine that is based on improper hindsight analysis. Petitioner
`
`fails to explain or analyze the rational underpinnings for why one of ordinary skill
`
`in the art would have combined the references relied upon, when in fact a person
`
`would have not been motivated to combine the references. For these and other
`
`reasons explained herein, the Board should deny in its entirety Elekta’s petition.
`
`II. OVERVIEW OF THE ’919 PATENT
`State of the Art
`A.
`At the time the ’919 Patent was filed, radiation therapy, or radiotherapy, was
`
`a well-practiced method of treatment for cancer, using ionizing radiation to kill
`
`
`
`1
`
`
`
`
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`cancer cells. Ex. 2001, Declaration of Kenneth Gall, at ¶47. By 2001, “the use of
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`linear accelerators for the generation of either electron radiation or X-ray radiation
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`[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 with a linear
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`accelerator (“linac”) or other radiation source mounted into a position to place a
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`radiation beam on a patient’s tumor. Ex. 2001 at ¶47; see also Ex. 2007 at 1:15-
`
`18. Because radiotherapy involved high-energy radiation, it was important to
`
`minimize the radiation dose received by the patient’s healthy tissue, while ensuring
`
`that the tumors receive a therapeutically effective dose. 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 essential to successful treatment. See Ex. 1001 at
`
`1:28-29; Ex. 2007 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 or
`
`shortly before treatment. Ex. 2001 at ¶48. It was important to minimize delays or
`
`movement of the patient between determining the location of the tumor and
`
`performing treatment. Id. Soft tissues in the human body could move over time,
`
`including while breathing, patient movement, or even just naturally. See, e.g., Ex.
`
`1001 at 1:30-34, 2:45-47; Ex. 2004 at 1:26-29; Ex. 2001 at ¶48. A delay between
`
`determining the location of the tumor and beginning treatment could result in
`
`
`
`2
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`
`
`
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`movement in the soft tissues. Ex. 2001 at ¶48. Any unadjusted misplacement of
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`the therapeutic radiation could result in the tumor not receiving an effective dose
`
`of radiation, and/or healthy tissue receiving a high dose of radiation. Id.
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`Obtaining diagnostic images of a patient using radiation beams (such as X-
`
`ray images) just prior to performing therapeutic treatment could confirm the
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`position of a tumor. Id. at ¶49. The therapeutic radiation source could be used for
`
`diagnostic imaging; however, the image quality was usually poor, as high-energy
`
`radiation did not provide as much soft-tissue contrast. See, e.g., Ex. 1001 at 1:40-
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`53; Ex. 2001 at ¶49. Therefore, a separate diagnostic radiation source such as a
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`low-energy X-ray could be used for diagnostic imaging. See, e.g., Ex. 1001 at
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`1:53-67; Ex. 2001 at ¶49. In some systems, a diagnostic radiation source could
`
`also be used for 3D computerized tomography (CT) scans, which would enable
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`three-dimensional reconstruction of the target volume and surrounding soft tissue.
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`See, e.g., Ex. 1001 at 4:50-58; Ex. 2001 at ¶49. A 3D image of the target volume
`
`could be used for improved treatment planning.
`
`In addition to the use of diagnostic imaging, proper positioning of the
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`therapeutic radiation source with minimal unnecessary movement was desirable.
`
`Ex. 2001 at ¶50. However, some radiotherapy systems required movement of
`
`components to provide a radiation beam at multiple angles relative to the patient.
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`These systems allowed for concentration of a radiation dose on a target volume
`
`
`
`3
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`
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`
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`from multiple angles (or even a continuous arc). Ex. 2001 at ¶ 50. At the same
`
`time, healthy cells surrounding the target volume were spared the full radiation
`
`dose, as different healthy cells were exposed to radiation at different angles. Ex.
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`2001 at ¶ 50. A radiotherapy system could provide radiation from multiple angles
`
`by using multiple radiation sources around the patient, or rotating a radiation
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`source around the patient. See, e.g., Ex. 1001 Fig. 1A; Ex. 1010 at 3, Fig. 1.1 In
`
`the case of a rotating therapeutic radiation source, it was important that any
`
`movement of therapeutic radiation sources be performed in a precisely-controlled
`
`manner to achieve the benefits of multiple angles, without unnecessary movement
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`adversely affecting beam placement. Ex. 2001 at ¶50; see Ex. 2005 at 2:23-27
`
`(discussing radiotherapy system in which movement of the therapeutic source is
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`“constrained to a single plane,” which “provides a number of benefits over”
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`systems that permit additional movement).
`
`In some radiotherapy systems, adding flexibility and movement of particular
`
`
`
`1 Varian notes that Petitioner alleges that Exs. 1006-1011 constitute prior art to the
`
`’919 Patent. Petitioner has failed to authenticate these exhibits or show they were
`
`publicly available by 2001. 37 C.F.R. §§ 42.61, 62, 64. While Varian addresses
`
`the teachings of these purported references, Varian reserves the right to object to
`
`these exhibits and to exclude these exhibits under 37 C.F.R. § 42.64.
`
`
`
`4
`
`
`
`
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`components (such as a diagnostic X-ray) could offer additional advantages. Ex.
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`2001 at ¶51. The gantry and attached equipment used in many radiotherapy
`
`systems weighed several tons and surrounded the patient, and movement of a
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`particular component could require the movement of the entire system, which
`
`could require additional time and energy. Id. An example radiotherapy system
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`cited by Petitioner as prior art2 shows at least four components of a rotatable
`
`gantry that were adjacent to the patient:
`
`
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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 components (labeled “MV Source,” “kV Imager,” “kV x-ray tube,” and “MV
`
`Imager”) were mounted on one gantry, and the components would rotate in unison
`
`around the patient via the drum structure of the gantry against the wall. Ex. 2001
`
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`2 See supra n. 1.
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`
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`5
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`
`
`
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`at ¶51. Allowing some of these components to move relative to the rest of the
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`system in a specific, controlled manner could offer greater flexibility in the system;
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`however, allowing the components to move freely would be detrimental to the
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`operation of a radiotherapy system, as explained below.
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`The speed of a rotating gantry and patient accessibility were considerations
`
`in the design of radiotherapy systems. For example, standards for medical
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`electrical equipment set by the International Electrotechnical Commission
`
`(“IEC”)3 required that equipment such as linacs have a speed limit, to ensure quick
`
`stoppage for safety purposes. Ex. 2006 at 8; Ex. 2001 at ¶52. Linacs were
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`typically restricted to a movement speed of approximately one revolution per
`
`minute. Id. Another consideration was ease of access to the patient. While the
`
`patient would usually lie on a treatment couch that was slid into treatment position,
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`if any issue arose while the radiotherapy system was in use, it would have been
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`desirable for the radiation technologist to have quick access to the patient. Ex.
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`2001 at ¶52. Because of the specialized nature of radiotherapy systems, a
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`POSITA would have generally focused on optimizing the systems for the specific
`
`
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`3 Compliance with IEC standards was needed for a product to receive a “CE” mark
`
`for use in Europe. See Ex. 2001 at ¶52, n.1. This standard was publicly available at
`
`least by the time of filing the ’919 Patent. Id.
`
`
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`6
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`
`
`
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`purpose of radiotherapy. Id.
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`Some radiotherapy systems prior to the invention of the ’919 Patent included
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`a diagnostic radiation source that could be used for treatment guidance (e.g., by
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`verifying that the therapeutic beam is properly aligned with the target volume).
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`Ex. 2001 at ¶53. As discussed in the ’919 Patent (and shown by the prior art
`
`asserted by Petitioner), these systems featured a gantry that held a therapeutic
`
`radiation source, a diagnostic radiation source, and at least one imager 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 and a
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`diagnostic radiation source, where the sources are fixed at a 90-degree orientation
`
`from each other:
`
`Ex. 1001 at Fig. 1A; Ex. 2001 at ¶53.
`
`
`
`7
`
`
`
`
`
`
`
`In 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. 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 offset between the diagnostic
`
`and therapeutic sources, there was a time delay in rotating the diagnostic source
`
`into the same relative position to the patient as the therapeutic source had been
`
`(due to the 1 revolution/minute FDA standard on the gantry holding the linac). Ex.
`
`2006 at 8; Ex. 2001 at ¶54. Switching from therapeutic to diagnostic sources along
`
`the same angle to the patient would have taken a not-insignificant amount of time.
`
`In the Fig. 1A system, a 3D CT reconstruction using the diagnostic source would
`
`have taken additional time, because of the rotation speed limit of the gantry. Ex.
`
`2006 at 8; Ex. 2001 at ¶54. Rotation of the entire gantry is demonstrated below in
`
`Fig. 1A of the ’919 Patent, where the green beam represents a diagnostic radiation
`
`beam and the red beam represents a therapeutic radiation beam along the same
`
`angle:
`
`
`
`8
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`
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`Ex. 2001 at ¶54.
`
`In the fields of radiotherapy and radiation-based imaging, a motivation to
`
`combine existing systems did not arise simply because a POSITA would have been
`
`aware of the existing systems. Ex. 2001 at ¶55. There were a number of different
`
`configurations
`
`for a
`
`radiotherapy system by 2001,
`
`including different
`
`configurations of a gantry holding one or more of therapeutic radiation sources,
`
`diagnostic radiation sources, and/or imagers. See, e.g., Ex. 2007; 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, specialized X-ray
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`devices such as mammographic X-ray equipment, dental extra-oral or intra-oral X-
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`ray devices, light ion beam therapeutic equipment, etc. See, e.g., Ex. 1004; Ex.
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`2001 at ¶55.
`
`While a POSITA 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. Such
`
`
`
`9
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`
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`combinations would have reduced the efficiency of the overall system or
`
`frequently resulted in an inoperable system. 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. See, e.g., Ex.
`
`2007 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 target can be
`
`irradiated from the same point either with a treatment beam or an x-ray beam, with
`
`every other variable remaining unchanged”); Ex. 2001 at ¶55.
`
`For example, there were many diagnostic systems such as X-ray radiography
`
`systems that could be positioned in a variety of ways around a target. Ex. 2001 at
`
`¶55. The X-ray system could be used to image the patient and detect objects such
`
`as broken bones, inflammation of soft tissue, 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 therapeutic beam
`
`would hit the target volume exactly where the diagnostic X-ray said it was. See
`
`Ex. 2007 at 1:31-34; Ex. 2001 at ¶55. This consideration required that the multiple
`
`components of a radiotherapy system be 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 known and accounted for
`
`
`
`10
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`
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`
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`throughout the procedure. Ex. 2001 at ¶55.
`
`A POSITA would not have used a 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 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 the prior art given
`
`a roadmap provided by a patent claim, which is what Petitioner is doing in this
`
`proceeding and specifically not allowed under the caselaw.
`
`Subject Matter of the ’919 Patent
`
`B.
`The ’919 Patent is directed to a radiotherapy device with an integrated
`
`diagnostic imaging system for directing a therapeutic radiation beam. See Ex.
`
`1001 at 2:65-3:2; Ex. 2001 at ¶57. The 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 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
`
`
`
`11
`
`
`
`
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`devices described in the ’919 Patent also includes a low-energy X-ray source in the
`
`kiloelectronvolt (“kV”) range that can be used for diagnostic purposes and
`
`verification. See Ex. 1001 at 4:40-49; Ex. 2001 at ¶58. While the therapeutic
`
`source is attached to a first gantry of the device described in the ’919 Patent, an
`
`imager is attached to a second gantry. Ex. 2001 at ¶58. By placing the therapeutic
`
`source and the imager on separate, independent structures, the imager can be
`
`moved or rotated without requiring the same movement by the therapeutic source.
`
`Id. Therefore, the rotation of the imager is not forced to 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:
`
`
`
`
`
`12
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`
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`
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`Ex. 2001 at ¶58.
`
`Using a separate, second gantry for the imager offered several benefits. As
`
`discussed above, the second gantry is not subject to the rotation speed standard for
`
`a linac. Ex. 2001 at ¶59. 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 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 various components of the described system
`
`and the respective ranges of motion with specific terms and limits. First, with
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`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
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`imaging can be performed through an independent structure from the therapeutic
`
`radiation source, “[t]he application of therapeutic radiation and diagnostic radiation
`
`
`
`13
`
`
`
`
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`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
`
`source:
`
`Rotation of the second gantry occurs in the same plane and about the same axis as
`
`the therapeutic radiation source, ensuring 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
`
`“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
`
`
`
`14
`
`
`
`
`
`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
`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,
`
`“articulable” refers specifically to the type of movement that moves the imager in
`
`and out of operative position, as demonstrated below with the example of Fig. 3B:
`
`
`
`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
`
`¶63. Again, “extend” and “retract” do not refer to movement in any direction, but
`
`rather refer to movement of the diagnostic (e.g., “second”) radiation source in and
`
`
`
`15
`
`
`
`
`
`out of an operative position, as example embodiment Fig. 3B demonstrates:
`
`
`
`Ex. 1001 at Fig. 3B; Ex. 2001 at ¶63.
`
`The ’919 Patent thus allows for specific flexibility of the radiotherapy
`
`system’s components. The system of the ’919 Patent does not simply allow each
`
`of its components (e.g. the therapeutic radiation source, the diagnostic radiation
`
`source, and at least one imager) to have degrees of freedom for the sake of adding
`
`flexibility. Ex. 2001 at ¶64. As discussed supra, the system of the ’919 Patent
`
`includes specific movements of each component that provide a particular benefit,
`
`not just any type of motion. Id.
`
`One of the advantages of the inventive system of the ’919 Patent is that the
`
`flexibility of the system allows for the diagnostic imaging to occur from particular
`
`angles, then for therapeutic radiation to be delivered to the target volume from
`
`substantially similar angles. Ex. 2001 at ¶65. The flexibility permitted in the ’919
`
`Patent specifically allows the diagnostic system to be moved to avoid interference.
`
`Id. Because the diagnostic radiation source and the therapeutic radiation source
`
`can be aligned on the same plane and can move out of the plane when the
`
`
`
`16
`
`
`
`
`
`diagnostic source is retracted (e.g. not in use), this system is flexible where needed,
`
`and immobile where a fixed angle is needed. Id.
`
`III. CLAIM CONSTRUCTION
`As explained below, Petitioner has failed to demonstrate a reasonable
`
`likelihood that any of the challenged claims are unpatentable, even if the Board
`
`adopts Petitioner’s constructions. Varian however disagrees with Petitioner’s
`
`constructions and reserves the right to offer constructions for additional terms,
`
`should those terms become relevant to either this or other proceedings. Varian
`
`also reserves the right to offer claim constructions in other proceedings, including
`
`district court litigation, that differ from those presented in this Preliminary
`
`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
`
`construction in a district court infringement action is different than the standard
`
`applied by the Board.”
`
`A. Level of Skill in the Art
`Petitioner states that a POSITA at the time the ’919 Patent was filed 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.”
`
`Pet. at 17. Petitioner overestimates the level of skill of a POSITA in an effort to
`
`
`
`17
`
`
`
`
`
`make the obviousness challenges easier. Ex. 2001 at ¶46. A person of ordinary
`
`skill in the art for the ’919 Patent would have had 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. Ex. 2001 at ¶45. A person with less education but more relevant
`
`practical experience may also meet this standard. Id. Varian’s arguments below
`
`are applicable under either standard proposed by the parties. Id. at ¶46.
`
`Legal Standard
`
`B.
`While claims are construed under a broadest reasonable interpretation
`
`standard in an inter partes review, “[t]he protocol of giving claims their broadest
`
`reasonable interpretation … does not include giving claims a legally incorrect
`
`interpretation.” Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed.
`
`Cir. 2015) (quoting In re Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir. 2009)). Claim
`
`language “must be read in accordance with the precepts of English grammar.”
`
`Nissim Corp. v. Time Warner, Inc., Appeal No. 2011-011260, at *4 (B.P.A.I. Feb.
`
`6, 2012) (quoting In re Hyatt, 708 F.2d 712, 714 (Fed. Cir. 1983)).
`
`“[E]xtrinsic evidence may be used only to assist in the proper understanding
`
`of the disputed limitation; it may not be used to vary, contradict, expand, or limit
`
`
`
`18
`
`
`
`
`
`the claim language from how it is defined, even by implication, in the specification
`
`or file history.’” CBS Interactive Inc. v. Helferich Patent Licensing, LLC, Case
`
`IPR2013-00033, Paper 122, at *14 (P.T.A.B. Mar. 3, 2014) (quoting Bell Atl.
`
`Network Servs. v. Covad Commc’ns Grp., 262 F.3d 1258, 1269 (Fed. Cir. 2001)).
`
`“gantry”
`
`C.
`Term
`
`Varian’s Construction
`
`Petitioner’s Construction
`
`“gantry”
`
`
`
`“arm”
`
`ordinary
`and
`Plain
`meaning, or alternatively
`“structure
`that
`holds
`radiation source(s) and/or
`imager(s).”
`
`The Board should reject Petitioner’s proposed construction and afford the
`
`term “gantry” its plain and ordinary meaning in the relevant art, e.g., “structure
`
`that holds radiation source(s) and/or imager(s).” In the relevant field of art, the
`
`literature customarily uses the term “gantry” for the component of the radiotherapy
`
`system that holds the therapeutic radiation source and any imagers or diagnostic
`
`sources. “Gantry” is not limited to a specific type of structure or component. Ex.
`
`2001 at ¶67.
`
`Petitioner has proposed that “gantry” should be construed as “arm,” and is
`
`basing that proposal on an example embodiment that describes particular “arms” as
`
`“gantries.” See Pet. at 18-19. However, in the relevant field of art, “gantry” and
`
`“arm” are not used interchangeably. Ex. 2001 at ¶68. Nor do
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