Trials@uspto.gov
`571-272-7822
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` Paper No. 69
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` Entered: May 4, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`VARIAN MEDICAL SYSTEMS, INC.,
`Petitioner,
`
`v.
`
`WILLIAM BEAUMONT HOSPITAL,
`Patent Owner.
`_________
`
`Case IPR2016-00166
`Patent 6,842,502 B2
`____________
`
`
`Before MICHAEL W. KIM, KALYAN K. DESHPANDE, and
`MATTHEW R. CLEMENTS, Administrative Patent Judges.
`
`KIM, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
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`571-272-7822
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` Paper No. 69
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` Entered: May 4, 2017
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`VARIAN MEDICAL SYSTEMS, INC.,
`Petitioner,
`
`v.
`
`WILLIAM BEAUMONT HOSPITAL,
`Patent Owner.
`_________
`
`Case IPR2016-00166
`Patent 6,842,502 B2
`____________
`
`
`Before MICHAEL W. KIM, KALYAN K. DESHPANDE, and
`MATTHEW R. CLEMENTS, Administrative Patent Judges.
`
`KIM, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
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`IPR2016-00166
`Patent 6,842,502 B2
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`I.
`
`INTRODUCTION
`Background
`A.
`Varian Medical Systems, Inc. (“Petitioner”) filed a Petition to institute
`an inter partes review of claims 43–46, 48–55, 57, 59–66, and 68 of U.S.
`Patent No. 6,842,502 B2 (Ex. 1301, “the ’502 Patent”). Paper 1 (“Pet.”).
`William Beaumont Hospital (“Patent Owner”) filed a Preliminary Response.
`Paper 11 (“Prelim. Resp.”).
`On May 6, 2016, we instituted an inter partes review of claims 43–46,
`48–55, 57, 59–66, and 68 on all grounds of unpatentability set forth in the
`Petition. (Paper 14; “Dec.”). After institution of trial, Patent Owner filed a
`Patent Owner Response (Paper 25, “PO Resp.”)1 and Petitioner filed a Reply
`(Paper 42, “Pet. Reply”). Petitioner relies on the Declarations of Dr. James
`J. Balter (Exs. 1302, 1500). Patent Owner relies on the Declaration of Ali
`Bani-Hashemi, Ph.D. (Ex. 2080). Patent Owner also filed a Motion to
`Exclude (Paper 49; “PO Mot.”), to which Petitioner filed an Opposition
`(Paper 55; “Pet. Opp.”) and Patent Owner filed a Reply (Paper 59; “PO
`Reply”).
`An oral hearing was held on January 31, 2017. Paper 66 (“Tr.”).
`The Board has jurisdiction under 35 U.S.C. § 6. In this Final Written
`Decision, issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73, we
`determine that Petitioner has not shown, by a preponderance of the evidence,
`
`
`1 Patent Owner’s Motion to Seal (Paper 27) was granted in our Order of
`January 3, 2017 (Paper 46). Unless otherwise indicated, all references
`herein to the Patent Owner Response will be to the public version (Paper
`26).
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`that any claim for which trial was instituted, claims 43–46, 48–55, 57, 59–
`66, and 68 of the ’502 patent, is unpatentable.
`
`Related Proceedings
`B.
`Petitioner and Patent Owner identify the following district court
`proceeding concerning the ’502 Patent: Elekta Ltd. and William Beaumont
`Hospital v. Varian Medical Systems, Inc., Case No. 2:15-cv-12169-AC-
`MKM (E.D. Mich.). Pet. 1; Paper 9, 1. Petitioner and Patent Owner identify
`further the following inter partes reviews also directed to the ’502 Patent:
`IPR2016-00160, IPR2016-00162, and IPR2016-00163. Pet. 1; Paper 9, 2.
`Patent Owner identifies additionally the following inter partes reviews
`directed to U.S. Patent No. 7,471,765 B2, which claims priority to the ’502
`Patent: IPR2016-00169, IPR2016-00170, and IPR2016-00171. Paper 9, 2.
`Patent Owner identifies also the following inter partes review directed to
`U.S. Patent No. 7,826,592 B2, which claims priority to the ’502 Patent:
`IPR2016-00187. Paper 9, 3.
`
`The ’502 Patent
`C.
`The ’502 Patent discloses that it is directed to a cone-beam computed
`tomography (“CBCT”) system that employs an amorphous silicon flat-panel
`imager (“FPI”) for use in radiotherapy applications where images of a
`patient are acquired with the patient in a treatment position on a treatment
`table. Ex. 1301, 1:11–17. Figure 17(b) (below) depicts a diagrammatic
`view of one orientation of an exemplary wall-mounted cone beam
`computerized tomography system employing a flat-panel imager. Ex. 1301,
`6:53–56.
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`Specifically, Figure 17(b) depicts wall-mounted cone beam computerized
`tomography system 400 including an x-ray source, such as x-ray tube 402,
`and flat-panel imager 404 mounted on gantry 406. Ex. 1301, 19:64–20:2.
`X-ray tube 402 generates a beam of x-rays in a form of a cone or pyramid.
`Ex. 1301, 20:2–4. Flat-panel imager 404 employs amorphous silicon
`detectors. Ex. 1301, 20:6–7.
`
`Illustrative Claims
`D.
`Petitioner challenges claims 43–46, 48–55, 57, 59–66, and 68 of the
`’502 Patent. Claims 43 and 60 are the only independent claims at issue, and
`are reproduced below:
`43. A method of treating an object with radiation,
`comprising:
`move a radiation source about a path;
`direct a beam of radiation from said radiation source
`towards an object;
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`emitting an x-ray beam in a cone beam form
`towards an object;
`detecting x-rays that pass through said object due to
`said emitting an x-ray beam with a flat-panel imager;
`generating an image of said object from said
`detected x-rays,
`wherein said generating comprises forming a
`computed tomography image of said object based on said
`detected x-rays,
`three
`least
`image contains at
`wherein said
`dimensional information of said object based on one
`rotation of said x-ray source around said object; and
`controlling said path of said radiation source based
`on said image.
`
`60. A method of treating an object with radiation,
`comprising:
`move a radiation source about a path;
`direct a beam of radiation from said radiation source
`towards an object;
`emitting an x-ray beam in a cone beam form
`towards an object;
`detecting x-rays that pass through said object due to
`said emitting an x-ray beam with a flat-panel imager;
` generating an image of said object from said
`detected x-rays,
`wherein said generating comprises forming a
`computed tomography image of said object based on said
`detected x-rays,
`three
`least
`image contains at
`wherein said
`dimensional information of said object based on one
`rotation of said x-ray source around said object; and
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`controlling a radiation therapy treatment plan
`involving said radiation source based on said image.
`E.
`Prior Art References Applied by Petitioner
`and Instituted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 43–46, 48–55, 57, 59–
`66, and 68 as obvious under 35 U.S.C. § 103(a) based on the following
`grounds and items of prior art (Pet. 15–51):
`
`Reference(s)
`
`Basis
`
`Challenged Claims
`
`Cho,2 Antonuk,3 Jaffray
`1997,4 Adler,5 and Depp6
`Cho, Antonuk, Jaffray 1997,
`Adler, Depp, and Yan7
`
`§ 103(a) 43–46, 48–55, 57, and
`59
`§ 103(a) 60–66 and 68
`
`
`2 P.S. Cho et al., Cone-beam CT for radiotherapy applications, Phys. Med.
`Biol., 40:1863-83 (1995) (Ex. 1305, “Cho”).
`3 L.E. Antonuk et al., Thin-Film, Flat-Panel, Composite Imagers for
`Projection and Tomographic Imaging, IEEE Transactions on Medical
`Imaging, 13:482-90 (1994) (Ex. 1306, “Antonuk”).
`4 D.A. Jaffray et al., Exploring “Target Of The Day” Strategies for A
`Medical Linear Accelerator With Conebeam-CT Scanning Capability,
`Proceedings of the 12th International Conference on the Use of Computers
`in Radiation Therapy, Medical Physics Publishing, pp. 172-75 (1997)
`(Ex. 1307, “Jaffray 1997”).
`5 U.S. Patent No. 5,207,223, issued May 4, 1993 (Ex. 1303, “Adler”).
`6 U.S. Patent No. 5,427,097, issued June 27, 1995 (Ex. 1304, “Depp”).
`7 D. Yan et al., The Use of Adaptive Radiation Therapy to Reduce Setup
`Error: A Prospective Clinical Study, Int’l J. Radiation Oncology Biol. Phys.,
`41:715-20 (1998) (Ex. 1308, “Yan”).
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`II. ANALYSIS
`Claim Construction
`A.
`In an inter partes review, a claim in an unexpired patent shall be given
`its broadest reasonable construction in light of the specification of the patent
`in which it appears. 37 C.F.R. § 42.100(b); see also Cuozzo Speed Techs.,
`LLC v. Lee, 136 S.Ct. 2131, 2142 (2016) (affirming that USPTO has
`statutory authority to construe claims according to 37 C.F.R. § 42.100(b)).
`Under the broadest reasonable construction standard, claim terms are
`generally given their ordinary and customary meaning, as would have been
`understood by one of ordinary skill in the art in the context of the entire
`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). For the purposes of this Decision, we determine that only the
`following claim term needs express interpretation. See Vivid Techs., Inc. v.
`Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those
`terms need be construed that are in controversy, and only to the extent
`necessary to resolve the controversy.”).
`1. “a computed tomography image of said object based on said
`detected x-rays, wherein said image contains at least three
`dimensional information of said object based on one
`rotation of said x-ray source around said object”
`Independent claims 43 and 60 recite “a computed tomography image
`of said object based on said detected x-rays, wherein said image contains at
`least three dimensional information of said object based on one rotation of
`said x-ray source around said object.” Petitioner asserts that “three
`dimensional information” should be construed as “information concerning
`three dimensions of an object (such as length, width, and depth).” Pet. 14–
`15 (citing Ex. 1301, 3:40–43; Ex. 1302 ¶ 37); Pet. Reply 1–5 (citing Exs.
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`1500 ¶¶ 9–258; 1502, 78:22–80:16, 83:14–87:11, 135:10–136:11).9 Patent
`Owner asserts that the aforementioned claim limitation, in its entirety,
`should be construed as “a volumetric image of an object generated by
`reconstructing 2-D projection images.” PO Resp. 11–15 (citing Ex. 1301,
`1:37–42, 1:45–54, 2:42–48, 2:51–55, 3:40–43, 3:54–55, 5:6–10, 16:43–45,
`16:58–62; Ex. 2080 ¶¶ 82–87). We agree with Petitioner.
`We begin first with the claim language, and note that “three
`dimensional information” appears facially to be co-extensive with any
`information relevant to three dimensions. We discern that “length, width,
`and depth” are just such information. We have considered Patent Owner’s
`above-cited portions of the ’502 Patent, but are unpersuaded that those
`portions narrow “three dimensional information” with sufficient “reasonable
`clarity, deliberateness, and precision” such that one of ordinary skill would
`have understood “three dimensional information” as co-extensive with
`Patent Owner’s proffered construction. In re Paulsen, 30 F.3d 1475, 1480
`(Fed. Cir. 1994). For example, column 2, lines 42–48 and 51–55 certainly
`disclose that “volume” is desirable, but does not provide any equivalence
`between “three dimensional information” and “volume.” Indeed, column 2,
`lines 54–55 disclose “provide information regarding the location of soft-
`tissue target volumes,” indicating that “information” is a subset of “volume.”
`
`
`8 In evaluating the assertions set forth in the Declaration of James Balter,
`Ph.D. in Support of Petitioner’s Reply (Ex. 1500), we considered Patent
`Owner’s Motion for Observations on the Cross-Examination of Dr. James
`Balter (Paper 48) and Petitioner’s Response to Patent Owner’s Motion for
`Observations on Cross-Examination (Paper 56).
`9 In the Decision on Institution, we preliminarily agreed with Petitioner’s
`proposed construction of “three dimensional information.” Dec. 8–9.
`
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`In another example, column 3, lines 40–43, mentions “three-dimensional (3-
`D) images,” which we agree would appear to require “volumetric” data;
`however, the claim limitation at issue is the broader term “three dimensional
`information.” In a further example, column 9, line 62, through column 10,
`line 5, clearly refers to “volumetric data,” but does not indicate its relation to
`“three dimensional information.” In yet another example, column 16, lines
`43–45 and 58–62, do not recite “three dimensional information,” instead
`disclosing “3-D structure” and “3-D nature” in relation generally to
`“volumetric data,” but, again, not in a manner sufficient to indicate a
`particular relationship.
`Finally, in regard to assertions set forth in the Declaration of Dr.
`Hashemi, we discern some merit in his assertion that when reading the claim
`limitation “three dimensional information” in conjunction with another
`claim limitation “computed tomography image,” “a cone beam computed
`tomography image is a volumetric image that provides the location, shape,
`and spatial orientation of the target volume in all directions, not just its
`length, width, and depth.” Ex. 2080 ¶ 83. The claim limitation at issue,
`however, reads “a computed tomography image of said object based on said
`detected x-rays, wherein said image contains at least three dimensional
`information of said object based on one rotation of said x-ray source around
`said object” (emphasis added). Accordingly, the claim limitation does not
`preclude an image having more information than “information concerning
`three dimensions of an object (such as length, width, and depth),” such as “a
`volumetric image of an object generated by reconstructing 2-D projection
`images.” Under Patent Owner’s construction, however, the image would be
`required to have such information. We are unpersuaded that such
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`information is required under a proper construction of “three dimensional
`information” for the reasons set forth supra.
`We construe “three dimensional information” as “information
`concerning three dimensions of an object (such as length, width, and
`depth).”
`
`Level of Ordinary Skill in the Art
`B.
`“Section 103(a) forbids issuance of a patent when ‘the differences
`between the subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains.’” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007).
`Dr. Balter, Petitioner’s expert, proffers that a hypothetical person of
`ordinary skill in the art, with respect to and at the time of the’502 patent,
`would have the following qualifications: “a medical physicist with a Ph.D.
`(or similar advanced degree) in physics, medical physics, or a related field,
`and two or more years of experience in radiation oncology physics and
`image processing/computer programming related to radiation oncology
`applications.” Ex. 1302 ¶ 14. Dr. Hashemi, Patent Owner’s expert,
`essentially agrees, with the only major differences to the above being that an
`M.S. is acceptable in lieu of a Ph.D, and that three years of experience is
`preferred. Ex. 2080 ¶ 17. Nominally, we accept Petitioner’s proffered level
`of ordinary skill in the art based on Dr. Balter’s more complete explanation.
`We note, however, that neither party has explained substantively any
`significance that the difference in the proffered levels of ordinary skill in the
`art would have in the obviousness analysis. See Graham v. John Deere Co.,
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`383 U.S. 1, 17–18 (1966); Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed.
`Cir. 2001) (“[T]he level of skill in the art is a prism or lens through which a
`judge, jury, or the Board views the prior art and the claimed invention.”);
`Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991) (“The
`importance of resolving the level of ordinary skill in the art lies in the
`necessity of maintaining objectivity in the obviousness inquiry.”). To that
`end, we note that the prior art itself often reflects an appropriate skill level.
`See Okajima, 261 F.3d at 1355.
`
`The Parties’ Post-Institution Arguments
`C.
`In our Decision on Institution, we concluded that the arguments and
`evidence advanced by Petitioner demonstrated a reasonable likelihood that
`claims 43–46, 48–55, 57, and 59 were unpatentable as obvious based on
`Cho, Antonuk, Jaffray 1997, Adler, and Depp, and in the case of claims 60–
`66 and 68, additionally Yan. Dec. 21–22. We must now determine whether
`Petitioner has established by a preponderance of the evidence that the
`specified claims are unpatentable over the cited prior art. 35 U.S.C.
`§ 316(e). We previously instructed Patent Owner that “any arguments for
`patentability not raised in the [Patent Owner Response] will be deemed
`waived.” Paper 15, 3; see also 37 C.F.R. § 42.23(a) (“Any material fact not
`specifically denied may be considered admitted.”). Additionally, the
`Board’s Trial Practice Guide states that the Patent Owner Response “should
`identify all the involved claims that are believed to be patentable and state
`the basis for that belief.” Office Patent Trial Practice Guide, 77 Fed. Reg.
`48,756, 48,766 (Aug. 14, 2012).
`In connection with the arguments and evidence advanced by
`Petitioner to support its positions that Patent Owner chose not to address in
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`its Patent Owner Response, the record now contains persuasive, unrebutted
`arguments and evidence presented by Petitioner regarding the manner in
`which the asserted prior art teaches corresponding elements of the claims
`against which that prior art is asserted. Based on the preponderance of the
`evidence before us, we conclude that the prior art identified by Petitioner
`describes all other limitations of the reviewed claims, except for those that
`Patent Owner contested in the Patent Owner Response, which we address
`below.
`
`D.
`
`Claims 43–46, 48–55, 57, and 59 as Unpatentable Over
`Cho, Antonuk, Jaffray 1997, Adler, and Depp
`Petitioner asserts that a combination of Cho, Antonuk, Jaffray 1997,
`Adler, and Depp renders obvious claims 43–46, 48–55, 57, and 59. Pet. 15–
`47. Patent Owner disagrees. PO Resp. 17–60. Petitioner replies. Pet.
`Reply 5–24. Claim 43 is the only independent claim for this ground.
`1.
`Cho (Ex. 1305)
`Cho describes a cone-beam CT system for radiotherapy applications,
`and algorithm used therein to permit an increased reconstruction volume to
`be imaged using a detector of a given size. Ex. 1305, Abstract. The system
`described in Cho is a digital spot imager (id. at 6), but Cho also describes the
`use of a flat panel detector for real-time diagnostic X-ray imaging.
`Ex. 1305, 24 (citing Antonuk). Cho describes generating a 3-D image “by
`rotating the gantry over 360º at approximately 1º increments.” Ex. 1305, 9,
`15–17.
`
`Antonuk (Ex. 1306)
`2.
`Antonuk describes “Thin-Film, Flat-Panel, Composite Imagers for
`Projection and Tomographic Imaging.” Ex. 1306, Title. Specifically,
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`Antonuk describes how “[t]he recent development of large-area, flat-panel a-
`Si:H imaging arrays is generally expected to lead to real-time diagnostic and
`megavoltage x-ray projection imagers with film-cassette-like profiles.” Ex.
`1306, Abstract. According to Antonuk, “[t]he construction, operation, and
`properties of the arrays have been extensively reported.” Ex. 1306, 3. “It is
`widely perceived that part of the solution is to obtain imaging information
`with the portal beam immediately prior to and/or during the treatment.” Ex.
`1306, 5. “Toward this aim of patient verification, a variety of real-time
`mega voltage imaging devices, including our a-Si:H imager, have been
`developed over the last decade.” Ex. 1306, 5. “This composite imager
`would be positioned behind the patient in the middle of the mega voltage
`radiation field during imaging.” Ex. 1306, 6, Fig. 5. In an alternative
`configuration, “[s]everal a-Si:H x-ray detectors rotate with an x-ray tube
`collecting conebeam projection data inside the bore of a PET machine.”
`Ex. 1306, 8.
`
`Jaffray 1997 (Ex. 1307)
`3.
`Jaffray 1997 describes “a conebeam-computed tomography (CB-CT)
`scanner for installation on our medical linear accelerator.” Ex. 1307, 4.10 A
`schematic of the dual-beam imaging system is shown in Figure 1 of Jaffray
`1997, which is reproduced below.
`
`
`10 Many Exhibits, such as Exhibit 1307, include two page numbers: the
`original page number from the source material itself, and the page numbers
`added by the parties. For consistency, we use the page numbers added by
`the parties.
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`Ex. 1307, 5. As shown in Figure 1, “[t]wo fluoroscopic imaging systems are
`attached to a Philips SL-20 medical linear accelerator; one detects the
`megavoltage image, the other a kV image produced with a kV beam
`projected at 90º to the treatment beam axis.” Ex. 1307, 4. Jaffray 1997
`states that the “gantry is rotated continuously” in order to generate a
`“conebeam imaging sequence consist[ing] of ~100 exposures over 194º of
`rotation.” Ex. 1307, 5.
`
`Adler (Ex. 1303)
`4.
`Adler teaches an apparatus and method for extending a surgical
`instrumentality to a target region in a patient, for example, for performing
`stereotaxic surgery using an x-ray linear accelerator. Ex. 1303, 1:6–10.
`Specifically, Adler teaches that a 3-dimensional mapping of a mapping
`region of at least a portion of a living organism is prepared. Ex. 1303, 3:64–
`68. First and second diagnostic beams are then passed through the mapping
`region, and are used to produce respective first and second images of
`respective first and second projections within the mapping region. Ex. 1303,
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`4:5–10. Adler then teaches that the 3-dimensional mapping and the first and
`second images are compared to derive therefrom data representative of a
`real-time location of a target portion of the mapping region. Ex. 1303, 4:41–
`46. Adler teaches further “adjusting the relative position of the beaming
`apparatus 20 and the patient 14 as needed in response to data which is
`representative of the real time location of the target region 18.” Ex. 1303,
`7:37–40.
`
`Depp (Ex. 1304)
`5.
`Depp teaches an apparatus for and method of carrying out stereotaxic
`radiosurgery and/or radiotherapy on a particular target region within a
`patient utilizing previously obtained reference data indicating the position of
`the target region with respect to its surrounding area, which also contains
`certain nearby reference points. Ex. 1304, 1:6–12. Depp further teaches the
`following:
`The apparatus also utilizes a pair of diagnostic beams of radiation
`or target locating beams, as they will be referred to in this
`discussion. These beams are passed through the surrounding
`area containing the target region and reference points and, after
`passing through the surrounding area, contain data indicating the
`positions of the reference points within the surrounding area.
`This position data is collected by cooperating detectors, as
`described previously, and delivered to the multiprocessor
`computer where the latter compares it with previously obtained
`reference data for determining the position of the target region
`with respect to each of the reference points during each such
`comparison. The radiosurgical beam is accurately directed into
`the target region in substantially real time based on this
`information.
`Ex. 1304, 11:46–61.
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`Petitioner’s Initial Positions
`6.
`Petitioner asserts that a combination of Cho, Antonuk, Jaffray 1997,
`Adler, and Depp renders obvious claims 43–46, 48–55, 57, and 59. Pet. 15–
`47. For example, independent claim 43 recites “move a radiation source
`about a path” and “direct a beam of radiation from said radiation source
`towards an object.” Petitioner cites Adler for teaching beaming apparatus 20
`performing stereotaxic surgery using an x-ray linear accelerator, and cites
`Antonuk and Jaffray 1997 for teaching medical linear accelerators. Pet. 25.
`Independent claim 43 also recites
`emitting an x-ray beam in a cone beam form towards an
`object:
`detecting x-rays that pass through said object due to said
`emitting an x-ray beam with a flat-panel imager;
`generating an image of said object from said detected x-
`
`rays,
`
`wherein said generating comprises forming a computed
`tomography image of said object based on said detected x-rays,
`Petitioner cites Cho and Jaffray 1997 for disclosing CBCT x-ray systems,
`and cites Cho and Antonuk for teaching a flat panel imager for receiving
`diagnostic x-rays and providing an image. Pet. 26–29. Independent claim 1
`also recites “wherein said image contains at least three dimensional
`information of said object based on one rotation of said x-ray source around
`said object.” Petitioner cites Cho for disclosing that “[t]he projection data
`were obtained by rotating the gantry over 360° at approximately 1°
`increments,” and for disclosing a modified Feldkamp algorithm for
`reconstructing the projection data into a 3-D image. Pet. 29–30 (quoting Ex.
`1305, 15); Ex. 1305, 22 (“data were available through a full 360° rotation.”).
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`Independent claim 1 also recites “controlling said path of said radiation
`source based on said image.” Petitioner cites Adler for disclosing the
`comparing of a previously obtained 3-dimensional mapping with newly
`acquired first and second images, and then adjusting patient treatment based
`on that comparison. Pet. 30–33. For a rationale to modify Cho, Antonuk,
`Jaffray 1997, Adler, and Depp in view of each other, Petitioner sets forth
`such a rationale on pages 33–37 of the Petition. Petitioner performs a
`similar analysis for dependent claims 44–46, 48–55, 57, and 59. Pet. 37–47.
`For the reasons explained in detail below, we agree with Petitioner that all
`limitations are taught by the prior art, and that a skilled artisan would have
`made the proffered modifications for the reasons set forth in the Petition.
`7.
`Patent Owner’s Assertions Concerning the References
`i.
`Missing Limitation
`Patent Owner asserts that the Petition does not account sufficiently for
`“the element of controlling the path of the radiation beam based on the three-
`dimensional information contained in the claimed image,” because Petitioner
`solely relies on Adler/Depp for the aforementioned claim element, and
`Adler/Depp does not disclose an image containing three-dimensional
`information. PO Resp. 21–24, 28–29. As an initial matter, we note that
`Patent Owner’s assertions are unpersuasive because they appear to presume
`a construction of “three-dimensional information” as requiring volumetric
`information. As set forth above, we construe “three-dimensional
`information” as “information concerning three dimensions of an object (such
`as length, width, and depth).” Adler discloses conducting radiosurgery using
`a 3-dimensional mapping (Ex. 1303, 4:41–46) and Depp discloses
`conducting radiosurgery and radiotherapy on a target region and reference
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`points in 3-dimensional space (Ex. 1304, 11:46–61), each of which we find
`corresponds properly to the aforementioned claim limitation.
`Moreover, Patent Owner’s assertions are misplaced, because
`Petitioner does not rely solely on Adler/Depp for “the element of controlling
`the path of the radiation beam based on the three-dimensional information
`contained in the claimed image.” PO Resp. 28–29; see Pet. 29–33; Pet.
`Reply 5. More specifically, the aforementioned claim “element” is not
`recited in a single limitation of independent claim 43, but instead appears to
`be an amalgamation of several express limitations, namely, “wherein said
`image contains at least three dimensional information of said object based on
`one rotation of said x-ray source around said object” and “controlling said
`path of said radiation source based on said image.” While for the latter
`limitation, Petitioner may rely solely on Adler/Depp, for the former
`limitation, Petitioner also relies on Cho/Antonuk/Jaffray 1997, the
`combination of which we are persuaded meet the entire limitation at issue.
`Pet. 29–30; Pet. Reply 5.
`Patent Owner asserts also that “[n]one of these references . . . either
`alone or in combination, shows the actual use of an FPI in the context of
`CBCT in the treatment room. (Ex. 2080 ¶ 109).” PO Resp. 25. Patent
`Owner’s assertions are misplaced, as Petitioner relies on a combination of
`references for the above, e.g., Cho/Antonuk for the FPI, Cho/Jaffray ’97 for
`CBCT, and Adler/Depp for the treatment room. See Pet. 30‒33. Patent
`Owner’s arguments are unpersuasive because they are directed to each
`individual reference’s failure to disclose the claim limitations, rather than to
`the combination of prior art disclosures. See In re Merck & Co. Inc., 800
`F.2d 1091, 1097 (Fed. Cir. 1986). Insofar as Patent Owner requires more by
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`using the word “actual,” we note that obviousness is a hypothetical exercise,
`given certain factual underpinnings, and so an example of “actual use” is
`unnecessary and beside the point.
`ii.
`Teaching Away
`Petitioner sets forth their rationale, for their proffered modification of
`the radiation therapy systems of Adler/Depp to include the CBCT/FPI
`system of Cho/Antonuk/Jaffray 1997, on pages 33–37 of the Petition which,
`for the reasons set forth below, we agree with and adopt. Patent Owner
`asserts that one of ordinary skill would not have modified the radiation
`therapy systems of Adler/Depp to include the CBCT/FPI system of
`Cho/Antonuk/Jaffray 1997, because both timing and dosage considerations
`teach away from the proposed combination. PO Resp. 29–36. We disagree.
`We begin with timing considerations. PO Resp. 29–34.
`Fundamentally, Patent Owner asserts that replacing the orthogonal 2-D
`images projections of Adler/Depp with the CBCT acquired images of
`Cho/Antonuk/Jaffray 1997 would represent “very poor methodology”
`because the CBCT system takes a significantly longer period of time to
`acquire and process images from a patient than the 2-D image system, e.g.,
`60 seconds to acquire the image, and 30–50 minutes to reconstruct the entire
`CT conebeam data set. PO Resp. 33–34. According to Patent Owner, such
`a delay is detrimental in the context of sending targeted radiation to a
`specific volume within the patient, because during that time, the patient from
`whom the images was acquired would most likely have shifted positions.
`PO Resp. 33–35.
`We are unpersuaded for several reasons. Primarily, we are
`unpersuaded because a fundamental assumption made by Patent Owner is
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`that the patient must remain unrestrained. Patent Owner makes this
`assumption based on the assertion that “the primary goal of the Adler/Depp
`systems is to permit a patient to be relatively unrestrained during the
`radiotherapy procedure.” PO Resp. 31. We have reviewed Patent Owner’s
`supporting evidence, and are unpersuaded that the evidence supports Patent
`Owner’s assertion that “the primary goal of the Adler/Depp systems is to
`permit a patient to be relatively unrestrained during the radiotherapy
`procedure.” For example, Patent Owner cites to certain paragraphs of Dr.
`Hashemi’s Declaration, which in turn cite to certain portions of Depp.
`Ex. 2080 ¶¶ 107, 123, 126 (citing Ex. 1304, 11:66–12:23, Fig. 9). We have
`reviewed those portions of Depp, and find that while they do disclose that
`target location and treatment periods are on the order of seconds, they do not
`mention anything about “the primary goal of the Adler/Depp systems is to
`permit a patient to be relatively unrestrained during the radiotherapy
`procedure.”11 Accordingly, absent such an evidentiary foundation, we do
`not find credible Dr. Hashemi’s assertions concerning this matter.
`Even without explicit analysis by Patent Owner, we logically
`understand the connection between longer image acquisition and processing
`times, and the higher likelihood of interim patient movement. Absent the
`aforementioned “primary goal,” however, we are unclear as to why the
`converse of that goal would not be correct, i.e., that one of ordinary skill
`would have resolved the timing consideration by restraining the patient.
`
`
`11 We also note that the use of the word “primary” indicates a general
`preference, which “does not criticize, discredit, or otherwise discourage the
`solution claimed . . . ,” as generall
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