Trials@uspto.gov Paper 69
`Tel: 571-272-7822
`
`Entered May 4, 2017
`
`
`
`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 IPR2016-00170
`Patent 7,471,765 B2
`____________
`
`
`
`Before MICHAEL W. KIM, KALYAN K. DESHPANDE, and
`MATTHEW R. CLEMENTS, Administrative Patent Judges.
`
`DESHPANDE, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`Inter Partes Review
`35 U.S.C. § 318(a); 37 C.F.R. § 42.73
`
`
`
`
`
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`

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`Case IPR2016-00170
`Patent 7,471,765 B2
`
`
`I.
`
`INTRODUCTION
`
`A. Background
`Varian Medical Systems, Inc. (“Petitioner”) filed a Petition to institute
`an inter partes review of claims 1‒13 and 20‒31 of U.S. Patent No.
`7,471,765 B2 (Ex. 1101, “the ’765 patent”). Paper 1 (“Pet.”). William
`Beaumont Hospital (“Patent Owner”) filed a Preliminary Response. Paper
`11 (“Prelim. Resp.”).
`Pursuant to 35 U.S.C. § 314, we instituted inter partes review of the
`ʼ765 patent, on May 5, 2016, under 35 U.S.C. § 103(a), as to claims 1‒13
`and 20‒31 on the basis that these claims would have been obvious over
`Cho,1 Antonuk,2 Jaffray 1997,3 Adler,4 and Depp.5 Paper 14 (“Dec.”).
`Patent Owner filed a Response (Paper 26, “PO Resp.”), and Petitioner
`filed a Reply (Paper 42, “Pet. Reply”). A consolidated oral hearing was held
`on January 31, 2017, and the hearing transcript has been entered in the
`record. Paper 66 (“Tr.”). Patent Owner also filed a Motion to Exclude
`
`
`1 P.S. Cho et al., Cone-beam CT for radiotherapy applications, Phys. Med.
`Biol., 40:1863-83 (1995) (Ex. 1105, “Cho”).
`2 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. 1106, “Antonuk”).
`3 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. 1107, “Jaffray 1997”).
`4 U.S. Patent No. 5,207,223, issued May 4, 1993 (Ex. 1103).
`5 U.S. Patent No. 5,427,097, issued June 27, 1995 (Ex. 1104).
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`(Paper 49, “PO Mot.”), to which Petitioner filed an Opposition (Paper 55,
`“Pet. Opp.”) and Patent Owner filed a Reply (Paper 59, “PO Reply”).
`After the oral hearing, we authorized additional briefing on the proper
`claim construction of the phrase “wherein said computer receives said image
`of said object and based on said image sends a signal to said radiation source
`that controls said path of said radiation source,” as recited by independent
`claim 1 of U.S. Patent 6,842,502 B2, and as similarly recited by independent
`claims 1, 7, 20, and 26. Paper 65. Patent Owner filed a Response (Paper 67)
`and Petitioner filed a Response (Paper 68).
`We have jurisdiction under 35 U.S.C. § 6. This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`Pursuant to our jurisdiction under 35 U.S.C. § 6, we conclude, for the
`reasons discussed below, Petitioner has not shown by a preponderance of the
`evidence that claims 1–13 and 20‒31 of the ʼ765 patent are unpatentable
`under 35 U.S.C. § 103(a).
`
`B. Related Proceedings
`The parties indicate that the ’765 patent is involved in the following
`district court case: Elekta Ltd. and William Beaumont Hosp. v. Varian Med.
`Sys., Inc., Case No. 2:15-cv-12169-AC-MKM (E.D. Mich.). Pet. 1; Paper 4,
`2. Petitioner and Patent Owner identify further the following inter partes
`reviews that also involve the ’765 patent: IPR2016-00169 and IPR2016-
`00171. Pet. 1; Paper 4, 1. Patent Owner identifies further the following
`inter partes reviews directed to U.S. Patent 6,842,502 B2 (“the ’502
`patent”), which the ’765 patent claims priority to: IPR2016-00160,
`IPR2016-00162, IPR2016-00163, and IPR2016-00166. Paper 4, 2. Patent
`Owner identifies further the following inter partes reviews directed to U.S.
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`Patent 7,826,592 B2, which claims priority to the ’765 patent: IPR2016-
`00187. Id.
`C. The ʼ765 Patent
`The ’765 patent discloses that it is directed to a cone-beam computed
`tomography system that employs an amorphous silicon flat-panel imager for
`use in radiotherapy applications where images of a patient are acquired with
`the patient in a treatment position on a treatment table. Ex. 1101, 1:16–21.
`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. Id. at 6:48–52.
`
`
`Specifically, Figure 17(b) above shows 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. Id. at
`19:41‒43. X-ray tube 402 generates beam of x-rays 407 in a form of a cone
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`or pyramid. Id. at 19:43‒46. Flat-panel imager 404 employs amorphous
`silicon detectors. Id. at 19:46‒47.
`D. Illustrative Claim
`Petitioner challenges claims 1‒13 and 20‒31 of the ’765 patent. Pet.
`14‒59. Claim 1 is illustrative of the claims at issue and is reproduced below:
`1. A radiation therapy system comprising:
`a radiation source that moves about an object and directs a
`beam of radiation towards said object;
`a cone-beam computed tomography system comprising:
`an x-ray source that moves about said object and
`emits toward said object from multiple positions around
`said object x-ray beams in a cone-beam form;
`a flat-panel imager positioned to receive x-rays after
`at least a portion of said x-ray beams pass through said
`object, said imager providing an image that contains three-
`dimensional information concerning said object based on
`a plurality of two-dimensional projection images; and
`a computer coupled to said cone-beam computed
`tomography system, wherein said computer receives said
`three-dimensional information and based on said three
`dimensional information received controls a path of said
`beam of radiation through said object by controlling a
`relative position between said radiation source and said
`object, wherein said receiving said x-rays by said flat
`panel imager is performed substantially at a time of
`occurrence of said controlling said path of said beam of
`radiation through said object.
`Ex. 1001, 28:2–24.
`Instituted Ground of Unpatentability
`E.
`We instituted inter partes review of claims 1–13 and 20‒31 of the
`’765 patent under 35 U.S.C. § 103(a) as obvious over a combination of Cho,
`Antonuk, Jaffray 1997, Adler, and Depp. Dec. 23.
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`
`II. ANALYSIS
`Claim Construction
`A.
`We interpret claims of an unexpired patent using the broadest
`reasonable interpretation in light of the specification of the patent in which
`they appear. See 37 C.F.R. § 42.100(b); see also Cuozzo Speed Techs., LLC
`v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest
`reasonable interpretation standard as the claim construction standard to be
`applied in an inter partes review proceeding). Under the broadest
`reasonable interpretation standard, claim terms are generally given their
`ordinary and customary meaning, as would be 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). 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.”).
`In our Decision on Institution, we were not persuaded that the terms
`“computer” (claim 1), “controller” (claim 7), “structure” (claim 20), and
`“support table” (claim 26) fail to recite sufficiently definite structure, and,
`therefore, we declined to construe these terms as means-plus-function
`limitations in accordance with 35 U.S.C. § 112 ¶ 6. Dec. 10‒12. Neither
`Patent Owner nor Petitioner provide any more argument or evidence to
`disturb our interpretation of these terms. See PO Resp. 12. Accordingly, we
`do not construe these terms as means-plus-function limitations under 35
`U.S.C. § 112 ¶ 6. See SAS Institute, Inc. v. ComplementSoft, LLC., 825 F.3d
`1341, 1351 (Fed. Cir. 2016) (The Board may not change a claim
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`interpretation from the institution decision where neither party anticipated
`that “already-interpreted terms were actually moving targets.”).
`Patent Owner offers constructions for the terms “radiation therapy
`system,” “cone-beam tomography system,” and “an image that contains
`three-dimensional information concerning said object based on a plurality of
`two-dimensional projection images.” PO Resp. 12‒17. In addition, after
`oral argument, we authorized briefing on the construction of “wherein said
`computer receives said image of said object and based on said image sends a
`signal to said radiation source that controls said path of said radiation
`source,” as recited by independent claim 1 of the ’502 patent, and as
`similarly recited by independent claims 1, 7, 20, and 26. Paper 65. Both
`parties submitted briefing. Papers 67, 68.
`For purposes of this Decision, we determine that it is necessary to
`construe only (1) “substantially at a time;” (2) the claim phrase containing
`“three-dimensional information;” and (3) “wherein said computer receives
`said three-dimensional information and based on said three dimensional
`information received controls a path of said beam of radiation through said
`object by controlling a relative position between said radiation source and
`said object.”
`1. “substantially at a time”
`In our Decision on Institution, we construed “substantially at a time”
`to mean “substantially at the same time,” where the “receiving” of the x-rays
`is substantially at the same time of the “controlling” of the radiation path.
`Dec. 7‒9. Neither Patent Owner nor Petitioner provides any more argument
`or evidence to disturb our construction of this term. See PO Resp. 12.
`Accordingly, after considering our initial construction anew in light of
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`Patent Owner’s assertions, we construe “substantially at a time” to mean
`“substantially at the same time,” where the “receiving” of the x-rays is
`substantially at the same time of the “controlling” of the radiation path.
`2. “an image that contains three-dimensional information
`concerning said object based on a plurality of two-
`dimensional projection images”
`Independent claim 1 recites “an image that contains three-dimensional
`information concerning said object based on a plurality of two-dimensional
`projection images.” Independent claims 7, 20, and 26 recite substantially
`similar limitations. Petitioner asserts that “three-dimensional information”
`should be construed as “information concerning three dimensions of an
`object (such as length, width, and depth).” Pet. 17 (citing Ex. 1101, 3:41–
`44; Ex. 1102 ¶ 39); Pet. Reply 1–4 (citing Exs. 1500 ¶¶ 9–23;6 1502, 78:22–
`80:16, 83:14–87:11, 135:10–136:11).7 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. 14–17 (citing Ex. 1101, 1:40–50, 2:44–56, 3:41‒56,
`5:5–9, 16:24‒28, 16:39‒42; Ex. 2080 ¶¶ 84–89). 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,
`
`
`6 In evaluating the assertions set forth in the Declaration of James Balter
`Ph.D. in Support of Petitioner’ 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).
`7 In the Decision on Institution, we preliminarily agreed with Petitioner’s
`proposed construction of “three-dimensional information.” Dec. 9–10.
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`and depth” are just such information. We have considered Patent Owner’s
`above-cited portions of the ’765 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 44‒56 certainly disclose that
`“volume” is desirable, but does not provide any equivalence between “three-
`dimensional information” and “volume.” Indeed, column 2, lines 55–56
`disclose “provide information regarding the location of soft-tissue target
`volumes,” indicating that “information” is a subset of “volume.” In another
`example, column 3, lines 41–56, 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 54‒64, clearly refers to
`“volumetric data,” but does not indicate its relation to “three-dimensional
`information.” In yet another example, column 16, lines 23–25 and 38–42,
`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 regards 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 “cone-beam computed tomography,” “a CBCT
`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,
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`and depth.” Ex. 2080 ¶ 85. Furthermore, the claim limitation does not
`preclude an image having more information than “three-dimensional
`information concerning said object” (such as length, width, and depth),
`“based on a plurality of two-dimensional projection images.” Under Patent
`Owner’s construction, however, the image would be required to have such
`information. We are unpersuaded that such 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).”
`
`3. “wherein said computer receives said three-dimensional
`information and based on said three dimensional
`information received controls a path of said beam of
`radiation through said object”
`Independent claim 1 recites “wherein said computer receives said
`three-dimensional information and based on said three-dimensional
`information received controls a path of said beam of radiation through said
`object.” Independent claims 7, 20 and 26 recite substantially similar
`limitations.8
`
`8 Patent Owner asserts that the limitation “wherein said computer receives
`said three-dimensional information and based on said three dimensional
`information received controls a path of said beam of radiation through said
`object” (hereinafter “controls a path”) is unique to independent claim 1, and
`“is not found in any other claims in this proceeding.” Paper 67, 1 n.1. We
`do not agree with Patent Owner. As an initial matter, dependent claims 2‒6
`incorporate this limitation by dependence on independent claim 1.
`Furthermore, independent claim 7 recites “a controller to control a path of
`said radiation through said object,” independent claim 20 recites “said
`radiation therapy system has a structure for controlling a path of said beam
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`Petitioner asserts that “[a person of ordinary skill in the art] would
`understand this claim language to encompass both a computer system
`operated by a user and a system that autonomously carries out the recited
`control function.” Paper 68, 1. Patent Owner agrees that “based on the
`intrinsic evidence and basic principles of claim construction, the relevant
`limitation of claim 1 of the ’765 patent should be construed to encompass a
`computer configured to permit human operation to perform the recited
`control function.” Paper 67, 5.
`Both parties agree that this construction is supported by both the
`intrinsic evidence and the extrinsic evidence. Paper 68, 1–5 (citing
`Ex. 1101, Abstract, 4:56–61, claims 1, 7, 13, 20, 26, 31);9 Paper 67, 1–5
`(citing Ex. 1001, 26:12–27, claim 1; Ex. 1112, 125‒126; Paper 66, 44:22‒
`45:13; Ex. 2084, WBH_Elekta_02082, WBH_Elekta_02116,
`WBH_Elekta_02169).
`We agree. We, therefore, construe “wherein said computer receives
`said image of said object and based on said image sends a signal to said
`
`
`of radiation through said object,” and independent claim 26 recites “said
`support table controls a path of said beam of radiation through said object.”
`As neither party has explained, and we are unable to discern independently,
`any substantive differences between the aforementioned limitations, we
`determine that all of these limitations are substantially similar to the
`“controls a path” limitation of independent claim 1. Dependent claims 8‒13,
`21‒25, and 27‒31 incorporate these limitations from independent claims 7,
`20, and 26 respectively. Accordingly, we determine that all of the remaining
`challenged claims, claims 2‒13 and 20‒31, recite substantially similar
`limitations to the “controls a path” limitation of independent claim 1.
`9 Petitioner further cites to papers and exhibits filed in IPR2016-00169.
`Paper 68 (citing IPR2016-00169: Ex. 1500 ¶¶ 36–38; Ex. 1502, 120:14–
`121:11; Ex. 2080 ¶¶ 61‒65, 108, 109, 126‒130).
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`radiation source that controls said path of said radiation source” to
`encompass a person or user operating the computer to perform the recited
`control functions. As discussed above, independent claims 7, 20, and 26
`recite similar limitations, and, therefore, we interpret these limitations to
`similarly encompass a person or user operating the computer to perform the
`recited control functions.
`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’765 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. 1102 ¶ 13. 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 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
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`art would have in the obviousness analysis. See Graham v. John Deere Co.,
`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 1–13 and 20–31 were unpatentable as obvious based on Cho,
`Antonuk, Jaffray 1997, Adler, and Depp. Dec. 23. 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 1‒13 and 20‒31 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 1–13 and 20‒31. Pet. 31–59.
`Patent Owner disagrees. PO Resp. 17–62. Petitioner replies. Pet. Reply 5–
`24. Claims 1, 7, 20, and 26 are the independent claims for this ground.
`1. Cho (Ex. 1105)
`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. 1105, 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. 1105, 24 (citing Antonuk). Cho describes generating a 3-D image “by
`rotating the gantry over 360º at approximately 1º increments.” Ex. 1105, 9,
`15–17.
`
`2. Antonuk (Ex. 1106)
`Antonuk describes “Thin-Film, Flat-Panel, Composite Imagers for
`Projection and Tomographic Imaging.” Ex. 1106, Title. Specifically,
`Antonuk describes how “[t]he recent development of large-area, flat-panel a-
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`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.
`1106, Abstract. According to Antonuk, “[t]he construction, operation, and
`properties of the arrays have been extensively reported.” Ex. 1106, 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.
`1106, 5. “Toward this aim of patient verification, a variety of real-time
`megavoltage imaging devices, including our a-Si:H imager, have been
`developed over the last decade.” Ex. 1106, 5. “This composite imager
`would be positioned behind the patient in the middle of the megavoltage
`radiation field during imaging.” Ex. 1106, 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. 1106, 8.
`3. Jaffray 1997 (Ex. 1107)
`Jaffray 1997 describes “a conebeam-computed tomography (CB-CT)
`scanner for installation on our medical linear accelerator.” Ex. 1107, 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 1107, 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. 1107, 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. 1107, 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. 1107, 5.
`4. Adler (Ex. 1103)
`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. 1103, 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. 1103, 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. 1103,
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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. 1103, 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. 1103,
`7:37–40.
`
`5. Depp (Ex. 1104)
`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. 1104, 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. 1104, 11:46–61.
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`6. Petitioner’s Initial Positions
`Petitioner asserts that a combination of Cho, Antonuk, Jaffray 1997,
`Adler, and Depp renders obvious claims 1–13 and 20‒31. Pet. 31–59. For
`example, claim 1 recites “[a] radiation therapy system.” Petitioner argues
`that Adler and Depp disclose a system for radiotherapy that is configured for
`selectively irradiating a target within a patient. Id. at 31‒32 (citing Ex.
`1103, Abstract, 3:62‒68; Ex. 1104, Abstract, 1:6‒12, 1:18‒26; Ex. 1102
`¶¶ 64‒65). Petitioner further argues that Antonuk and Jaffray 1997 also
`disclose radiotherapy systems using a medical linear accelerator device. Id.
`at 32.
`Claim 1 further recites “a radiation source that moves about an object
`and directs a beam of radiation towards said object.” Petitioner argues that
`Adler/Depp discloses that the beaming apparatus can be adjusted such that
`the collimated beam is continuously focused on the target region. Id. at 32‒
`33 (citing Ex. 1103, 7:52‒58; Ex. 1104, 5:25‒31). Petitioner further argues
`that Jaffray 1997 and Antonuk disclose the use of a radiation source. Id. at
`33 (citing Ex. 1107, 4; Ex. 1106, 3, 5).
`Claim 1 also recites “a cone-beam computed tomography system
`comprising: an x-ray source that moves about said object and emits toward
`said object from multiple positions around said object x-ray beams in a
`cone-beam form.” Petitioner argues that Cho discloses a cone-beam
`computed tomography (“CBCT”) system that generates a 3-D image by
`rotating an x-ray source around an object. Id. at 33‒34 (citing Ex. 1105, 15).
`Petitioner further argues that Jaffray 1997 discloses a cone beam CT
`apparatus that uses a linear accelerator that obtains 3-D information from a
`plurality of 2-D projection images by rotating the gantry around a patient.
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`Id. at 34 (citing Ex. 1107, 4‒5). Petitioner further argues, applying the
`testimony of Dr. Balter, that Antonuk discloses an x-ray source that emits
`beams in a con-beam geometry. Pet. 34‒35 (citing Ex. 1106, Fig. 5; Ex.
`1102 ¶ 72).
`Claim 1 additionally recites “a flat-panel imager positioned to receive
`x-rays after at least a portion of said x-ray beams pass through said object,
`said imager providing an image that contains three-dimensional information
`concerning said object based on a plurality of two-dimensional projection
`images.” Petitioner argues that Cho discloses an amorphous silicon flat
`panel imager (“FPI”) that detects cone-beam x-ray projection images, and
`Cho specifically references to Antonuk for its FPI. Id. at 35 (citing Ex.
`1105, 24). Petitioner then argues that Antonuk discloses flat panel imagers
`as diagnostic x-ray detectors mounted on a linear accelerator for imaging
`during radiotherapy. Id. (citing Ex. 1106, 3). Petitioner argues, as explained
`by Dr. Balter, the FPI devices detect multiple x-ray beams that pass through
`an object being imaged, and each FPI receives a plurality of 2-D x-rays. Id.
`at 35‒36 (citing Ex. 1106, Fig. 5; Ex. 1102 ¶¶ 58, 73‒74). Petitioner argues
`that Adler/Depp disclose obtaining two x-ray images at a known angle
`relative to one another, and, therefore, providing three-dimensional
`information about the imaged object. Id. at 36‒37 (citing 1103, 7:6‒12,
`7:17‒23; Ex. 1102 ¶ 75).
`Claim 1 further recites:
`a computer coupled to said cone-beam computed tomography
`system, wherein said computer receives said three-dimensional
`information and based on said three dimensional information
`received controls a path of said beam of radiation through said
`object by controlling a relative position between said radiation
`source and said object, wherein said receiving said x-rays by said
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`flat panel imager is performed substantially at a time of
`