Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 79
`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 IPR2016-00163
`Patent 6,842,502 B2
`_______________
`
`
`
`Before MICHAEL W. KIM, KALYAN K. DESHPANDE, and
`MATTHEW R. CLEMENTS, Administrative Patent Judges.
`
`CLEMENTS, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`Paper 79
`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 IPR2016-00163
`Patent 6,842,502 B2
`_______________
`
`
`
`Before MICHAEL W. KIM, KALYAN K. DESHPANDE, and
`MATTHEW R. CLEMENTS, Administrative Patent Judges.
`
`CLEMENTS, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`
`IPR2016-00163
`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. 1201, “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 based on the two 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.”) and Petitioner
`filed a Reply (Paper 50, “Pet. Reply”).1 Petitioner relies on the Declarations
`of James Balter, Ph.D. (Exs. 1202, 1500). Patent Owner relies on the
`Declaration of Ali Bani-Hashemi, Ph.D. (Ex. 2080). Patent Owner also filed
`a Motion to Exclude (Paper 59, “PO Mot.”), to which Petitioner filed an
`Opposition (Paper 65, “Pet. Opp.”) and Patent Owner filed a Reply (Paper
`69, “PO Reply”).
`An oral hearing was held on January 31, 2017. Paper 76 (“Tr.”).
`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,” recited in claim 1. Paper 75.
`
`
`1 Petitioner’s Motion to Seal (Paper 49) was granted in our Order of January
`3, 2017 (Paper 56). Unless otherwise indicated, all references herein to the
`Reply will be to the public version (Paper 51).
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`Patent Owner filed a Response (Paper 77) and Petitioner filed a Response
`(Paper 78).
`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 met its burden of showing, by a
`preponderance of the evidence, that any claim for which trial was instituted
`is unpatentable. Patent Owner’s Motion to Exclude is denied.
`
`Related Proceedings
`B.
`Petitioner and Patent Owner identify the following district court
`proceedings concerning the ’502 Patent: Elekta Ltd. and William Beaumont
`Hosp. v. Varian Med. Sys., 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 IPR2016-00166. 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:
`IPR2015-00169, 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. 1201, 1:11–17. Figure 17(b) (below) depicts a diagrammatic
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`view of one orientation of an exemplary wall-mounted cone beam
`computerized tomography system employing a flat-panel imager. Ex. 1201,
`6:53–56.
`
`
`Specifically, Figure 17(b) depicts wall-mounted cone beam computerized
`tomography system 400 includes an x-ray source, such as x-ray tube 402,
`and flat-panel imager 404 mounted on gantry 406. Ex. 1201, 19:64–67. X-
`ray tube 402 generates beam of x-rays 407 in a form of a cone or pyramid.
`Ex. 1201, 19:67–20:2. Flat-panel imager 404 employs amorphous silicon
`detectors. Ex. 1201, 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;
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`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,
`
`treating an object with radiation,
`
`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
`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
`controlling a radiation therapy treatment plan involving said
`radiation source based on said image.
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`Instituted Grounds of Unpatentability
`E.
`We instituted inter partes review of claims 43–46, 48–55, 57, 59–66,
`and 68 on the following grounds.
`
`Reference(s)
`
`Basis
`
`Challenged Claims
`
`Jaffray 1999 SPIE,2 Jaffray
`1999 JRO,3 Adler,4 and Depp5
`Jaffray 1999 SPIE, Jaffray 1999
`JRO, Adler, Depp, and Yan6
`II. ANALYSIS
`
`§ 103(a) 43–46, 48–55, 57, 59
`
`§ 103(a) 60–66, 68
`
`A. Claim Construction
`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 given
`their ordinary and customary meaning, as would be understood by one of
`
`
`2 D.A. Jaffray et al., Performance of a Volumetric CT Scanner Based
`Upon a Flat-Panel Imager, SPIE, 3659:204–14 (Feb. 1999) (Ex. 1205,
`“Jaffray 1999 SPIE”).
`3 D.A. Jaffray et al., A Radiographic and Tomographic Imaging System
`Integrated into a Medical Linear Accelerator for Localization of Bone and
`Soft-Tissue Targets, Int. J. Radiation Oncology Biol. Phys., 45:773–89 (Oct.
`1999) (Ex. 1206, “Jaffray 1999 JRO”).
`4 U.S. Patent No. 5,207,223, issued May 4, 1993 (Ex. 1203).
`5 U.S. Patent No. 5,427,097, issued June 27, 1995 (Ex. 1204).
`6 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. 1207, “Yan”).
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`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). Any special
`definition for a claim term must be set forth in the specification with
`reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d
`1475, 1480 (Fed. Cir. 1994). We must be careful not to read a particular
`embodiment appearing in the written description into the claim if the claim
`language is broader than the embodiment. In re Van Geuns, 988 F.2d 1181,
`1184 (Fed. Cir. 1993). Only terms which are in controversy need to be
`construed, and then only to the extent necessary to resolve the controversy.
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`1999).
`Petitioner proposes constructions for “based on one rotation,” “three
`dimensional information,” and “a computer . . . that controls said path of
`said radiation source.” Pet. 12–14. In our Decision on Institution, we
`determined that it was necessarily to construe only “three dimensional
`information.” Dec. 6–8. Patent Owner contests our construction of “three
`dimensional information.” PO Resp. 11–14. Specifically, Patent Owner
`contends that “three dimensional information” must be construed in the
`context of the claim phrase “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,” as recited in independent claims 43 and 60. Id.
`In addition, after oral argument, we authorized briefing on the correct
`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
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`said path of said radiation source.”7 Paper 75. Both parties submitted
`briefing. Papers 77, 78.
`For purposes of this Decision, we determine that it is necessary to
`construe only (1) the claim phrase containing “three dimensional
`information;” and (2) “controlling [said path of / a radiation therapy
`treatment plan involving] said radiation source based on said image.”
`
`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 each 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 (citing Ex. 1201, 3:40–43; Ex. 1202 ¶ 37); Pet. Reply 1–5
`(citing Exs. 1500 ¶¶ 7–238; 1502, 78:22–80:16, 83:14–87:11, 135:10–
`
`
`7 Independent claim 43 recites a commensurate limitation: “controlling said
`path of said radiation source based on said image.” Independent claim 60
`recites a commensurate limitation: “controlling a radiation therapy
`treatment plan involving said radiation source based on said image.”
`8 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 58) and Petitioner’s Response to Patent Owner’s Motion for
`Observations on Cross-Examination (Paper 66).
`
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`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. 11–14
`(citing Ex. 1201, 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 ¶¶ 88–93). 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. Circ 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.”
`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
`
`9 In the Decision on Institution, we preliminarily agreed with Petitioner’s
`proposed construction of “three-dimensional information.” Dec. 7–8.
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`“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 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,
`and depth.” Ex. 2080 ¶ 91. The claim limitation at issue, however, reads
`“an image of said object, 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 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).”
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`2. “controlling [said path of / a radiation therapy treatment plan
`involving] said radiation source based on said image.”
`Independent claim 43 recites “controlling said path of said radiation
`source based on said image,” and independent claim 60 recites “controlling a
`radiation therapy treatment plan involving said radiation source based on
`said image.”
`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 78, 1. Patent Owner agrees that “based on the
`intrinsic evidence and basic principles of claim construction, the relevant
`limitation of claim 1 of the ’502 patent should be construed to encompass a
`computer configured to permit human operation to perform the recited
`control function.”10 Paper 77, 5.
`Both parties agree that this construction is supported by both the
`intrinsic evidence and the extrinsic evidence. Paper 78, 1–5 (citing
`Ex. 1201, Abstract, 4:57–62, claim 1, claim 34; Ex. 1500 ¶¶ 32–34;
`Ex. 1502, 120:14–121:11; IPR2016-00160, Ex. 2080 ¶¶ 61–65, 99, 112–116,
`127); Paper 77, 1–5 (citing Ex. 1201, 26:39–55, claim 1; Ex. 1212, 125–26;
`Tr. 31:1–33:13; Ex. 2080 ¶ 99; Ex. 2084, WBH_Elekta_01890,
`WBH_Elekta_01920, WBH_Elekta_01948, WBH_Elekta_01971; IPR2016-
`00162, Paper 66, 44:22–45:13). In particular, both parties agree that claim 1
`is open-ended and non-limiting, and is necessarily broader than dependent
`
`
`10 Patent Owner’s briefing addresses the commensurate limitation recited in
`claim 1, but neither party argues, and we discern no reason why, the
`limitations recited in claims 43 and 60 should be construed to have a scope
`different than the limitation recited in claim 1.
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`claim 34, which specifies that the recited control of said radiation path is “in
`an automatic manner without human intervention.” The same reasons apply
`to independent claims 43 and 60. Both are open-ended and non-limiting,
`and both are necessarily broader than their respective dependent claims, 58
`and 69, which specify that the recited controlling “is performed
`automatically and without human intervention.”
`We agree. We, therefore, construe “controlling [said path of / a
`radiation therapy treatment plan involving] said radiation source based on
`said image” to encompass a person or user operating the computer to
`perform the recited control functions.
`
`B. Level of Ordinary Skill in the Art
`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. 1202 ¶ 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
`because it is 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 play 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
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`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.
`
`C. Whether Jaffray 1999 SPIE and Jaffray 1999 JRO
` are Prior Art to Claims 43–46, 48–55, 57, 59–66, and 68
`Petitioner asserts that (1) claims 43–46, 48–55, 57, 59–66, and 68 are
`not entitled to the benefit of priority of the February 18, 2000 filing date of
`provisional application no. 60/183,590 (“the ’590 Application”), and, thus,
`Jaffray 1999 SPIE and Jaffray 1999 JRO are prior art under 35 U.S.C.
`§ 102(b)11 (Pet. 14–16; Reply 6–10); and (2) even if the claims are entitled
`to the benefit of the February 18, 2000, filing date of the ’590 Application,
`Jaffray 1999 SPIE and Jaffray 1999 JRO are still prior art under 35 U.S.C.
`§ 102(a) (Pet. 18; Reply 10–20).
`Patent Owner asserts that (1) the challenged claims are entitled to the
`benefit of priority of the February 18, 2000 filing date of the
`’590 Application, and, thus, Jaffray 1999 SPIE and Jaffray 1999 JRO are not
`prior art under 35 U.S.C. § 102(b) (PO Resp. 14–28); and (2) Jaffray 1999
`SPIE and Jaffray 1999 JRO are not prior art under 35 U.S.C. § 102(a),
`because the portions of Jaffray 1999 SPIE and Jaffray 1999 JRO upon which
`
`
`11 All references to 35 U.S.C. §§ 102, 103 herein will be pre-AIA.
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`Petitioner relies is the work of the named inventors of the ’502 Patent, not of
`the coauthors not named as inventors (id. at 28–39).
`We agree with Patent Owner for the reasons explained below.
`1.
`Principles of Law
`Petitioner has the burden of persuasion to prove unpatentability by a
`preponderance of the evidence. Dynamic Drinkware, LLC v. Nat’l
`Graphics, Inc., 800 F.3d 1375, 1379 (Fed. Cir. 2015). Petitioner also has the
`initial burden of production to show that a reference is prior art to certain
`claims under a relevant section of 35 U.S.C. § 102. Id. Once Petitioner has
`met that initial burden, the burden of production shifts to Patent Owner to
`argue or produce evidence that the asserted reference is not prior art to
`certain claims, for example, because those claims are entitled to the benefit
`of priority of an earlier filed application. Id. at 1380. Once Patent Owner
`has met that burden of production, the burden is on Petitioner to show that
`the claims at issue are not entitled to the benefit of priority of the earlier filed
`application. Id.
`Section 102(a) of 35 U.S.C. recites “[a] person shall be entitled to a
`patent unless . . . (a) the invention was known or used by others in this
`country, or patented or described in a printed publication in this or a foreign
`country, before the invention thereof by the applicant for patent.” “[O]ne’s
`own work is not prior art under § 102(a) even though it has been disclosed to
`the public in a manner or form which otherwise would fall under § 102(a).”
`In re Katz, 687 F.2d 450, 454 (Fed. Cir. 1982). Generally, “a patent is ‘to
`another’ when the ‘inventive entities’ are different.” Application of Fong,
`378 F.2d 977, 980 (CCPA 1967); see also In re Land and Rogers, 368 F.2d
`866, 877 (CCPA 1966) (“There appears to be no dispute as to the law that A
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`is not ‘another’ as to A, B is not ‘another’ as to B, or even that A & B are
`not ‘another’ as to A & B. But that is not this case, which involves, . . . , the
`question whether either A or B is ‘another’ as to A & B as joint inventors
`under section 102(e)”).
`What we have in this case is ambiguity created by the
`printed publication. The article does not tell us anything specific
`about inventorship, and appellant is only one of three authors
`who are reporting on scientific work in which they have all been
`engaged in some capacity at the Harvard Medical School. It was
`incumbent, therefore, on appellant to provide a satisfactory
`showing which would lead to a reasonable conclusion that he is
`the sole inventor.
`In re Katz, 687 F.2d at 455 (footnote omitted).
`2. Whether Jaffray 1999 SPIE and Jaffray 1999 JRO are
`Prior Art to claims 43–46, 48–55, 57, 59–66,
` and 68 under 35 U.S.C. § 102(b)
`Applying the framework from Dynamic Drinkware, we determine that
`Petitioner has met its initial burden of production by asserting that
`independent claims 43 and 60 are not entitled to the benefit of priority of the
`’590 Application, and, thus, that both Jaffray 1999 SPIE and Jaffray 1999
`JRO are prior art under 35 U.S.C. § 102(b). Pet. 14–18. Specifically,
`Petitioner asserts that “the challenged claims require the claim element of
`controlling the path of a radiation source based on a three-dimensional
`image obtained through a single CBCT rotation” and that the ’590
`Application does not provide sufficient written description support for that
`element because “the provisional application discloses a benchtop
`CBCT-FPI system” and “has no discussion of using the benchtop system to
`control a path of a radiotherapy beam.” Id. at 15; see also id. at 16 (“One of
`ordinary skill in the art, reviewing the ’590 [Application], would not have
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`recognized that the applicants possessed the invention they claimed.”). As a
`result, according to Petitioner, the effective date of independent claims 43
`and 60 is February 16, 2001, the filing date of U.S. Application No.
`09/788,335, which issued as the ’502 Patent. Id. at 16. Petitioner concludes
`that Jaffray 1999 SPIE and Jaffray 1999 JRO are each prior art under 35
`U.S.C. § 102(b), because each has a publication date earlier than February
`18, 2000. Id. at 17–18.
`The burden of production having shifted to Patent Owner, Patent
`Owner asserts that independent claims 43 and 60 are entitled to the benefit
`of priority of the ’590 Application, because the ’590 Application provides
`sufficient written description support for the disputed limitations
`(“controlling said path of said radiation source based on said image” in
`claim 43, and “controlling a radiation therapy treatment plan involving said
`radiation source based on said image” in claim 60). PO Resp. 14–28 (citing
`Polaris Wireless, Inc. v. TruePosition, Inc., Case No. IPR2013-00323, 2013
`WL 8563953, at *17 (PTAB Nov. 15, 2013) (Paper 9) (“Patent Owner has to
`make a sufficient showing of entitlement to earlier filing date or dates, in a
`manner that is commensurate in scope with the specific points and
`contentions raised by Petitioner.”)). Specifically, Patent Owner identifies
`several portions of the ’590 Application that allegedly provide written
`description support for the aforementioned limitations of independent claims
`43 and 60.
`Patent Owner principally identifies the following portions: “[t]he
`specific geometries used in the discussion herein are shown in Figure 2, and
`are set to simulate the imaging geometry that would be implemented for a
`CBCT system incorporated on a radiotherapy treatment machine” (Ex. 1210,
`
`16
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`IPR2016-00163
`Patent 6,842,502 B2
`
`7:13–16); “the host computer advances the motorized rotation stage”
`(Ex. 1210, 11:6); and “[a] CBCT system is proposed for radiotherapy
`guidance on a treatment-by-treatment basis using CT data obtained with a
`kV x-ray source and a large-area, indirect detection flat-panel imager (FPI).
`This imaging system can be installed on a conventional radiotherapy linear
`accelerator for application to image-guided radiation therapy” (Ex. 1210,
`6:11–15). PO Resp. 19–20. In addition, Patent Owner identifies Figure 3 of
`the ’590 Application, and provides an annotated comparison, reproduced
`below, to Figure 17(c) of the ’502 Patent:
`
`
`
`Id. at 21.
`Patent Owner also argues that “it was well-known to a POSA at the
`time of the invention that conventional linear accelerators included
`computer-controlled support tables to position the patient (and thus guide the
`path of the radiation source)” (PO Resp. 25), and that “a [person of ordinary
`skill in the art] would have recognized that the disclosed drum-based Elekta
`
`17
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`IPR2016-00163
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`
`linear accelerator”—like that disclosed in Figure 3 of the ’590 Application—
`“included a computer control system, which facilitated control of the
`treatment couch to adjust the relative position of the patient and radiation
`source” (PO Resp. 25–26 (citing Ex. 2080 ¶¶ 60–65, 104–110, 121–124);
`see also id. at 26–27 (citing Ex. 2080 ¶¶ 59–60, 101, 106, 111–113, 124).
`As a result, according to Patent Owner, a person of ordinary skill in the art
`would have understood the ’590 Application’s disclosure of “image-guided
`radiation therapy” (Ex. 1210, 6:14–15), “guiding radiation therapy on a
`medical linear accelerator” (id. at 31:6–7), “on-line imaging and guidance”
`(id. at 1:19), “on-line tomographic guidance” (id. at 2:18–19), and
`“navigational imaging for therapies” (id. at 30:5–6) to
`constitute an express disclosure of the process of imaging a target
`tumor immediately prior to treatment, comparing the image to
`prior diagnostic or simulation images, and correcting the
`patient’s position by controlling the position of the treatment
`couch relative to the treatment beam (thus controlling the path of
`the radiation source)
`PO Resp. 23. Patent Owner concludes that
`From these express disclosures of on-line image-guided radiation
`therapy on a medical linear accelerator with computer-controlled
`image acquisition of CBCTFPI images (Ex. 2080 ¶ 101; Ex.
`1210 at 0011) and a translatable treatment couch for positioning
`the patient based on the images, a POSA would have recognized
`that the ’502 patent inventors were in possession of the limitation
`of controlling the path of the radiation source based on 3-D
`CBCT-FPI image information, which would have involved
`imaging the patient at the time of treatment, comparing the
`images
`to prior diagnostic or simulation
`images, and
`repositioning the patient based on the images. (Id. ¶¶ 59-60, 124).
`Id. at 27.
`
`18
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`
`We find that Patent Owner has produced sufficient evidence to have
`met its burden of production, and the burdens12 concerning this issue are on
`Petitioner. Petitioner replies that the ’590 Application’s disclosure of
`“image-guided radiation therapy” and “navigational imaging for therapies”
`do not support the disputed limitations—“where controlling is ‘based on’ the
`image” (Pet. Reply 8)—because “even if the provisional is considered to
`inherently disclose control of patient position by couch movements, this is
`an entirely different class of control step from controlling source path” (id. at
`8–9).
`Having considered the arguments and evidence, we agree with Patent
`Owner that the ’590 Application provides sufficient written description
`support for “controlling [said path of / a radiation therapy treatment plan
`involving] said radiation source based on said image.” In particular, we
`credit the testimony of Dr. Hashemi that a person of ordinary skill in the art
`would have understood from the ’590 Application that components of the
`disclosed system were computer-controlled based upon, e.g., the depiction of
`an Elekta SL-20 in Figure 3 of the ’590 Application and from the depiction
`of an electronic portal imaging device. (Ex. 2080 ¶¶ 109–116, 125–132).
`Petitioner’s arguments are not persuasive because, even assuming that
`controlling the source path and controlling a radiation therapy treatment plan
`are “an entirely different class of control step” from controlling patient
`position (Pet. Reply 8–9), Petitioner has not explained why the portions of
`the ’590 Application relied upon by Patent Owner do not disclose
`controlling the source path or controlling a radiation therapy treatment plan.
`
`
`12 Both the burden of production and the burden of persuasion.
`
`19
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`IPR2016-00163
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`
`To the extent that Petitioner is arguing that the ’590 Application does not
`teach control exclusively by the computer without human intervention, that
`argument is not persuasive because we have construed the limitations to
`encompass a person or user operating the computer to perform the recited
`control functions. In post-hearing briefing, both parties agree that this is the
`proper construction. Papers 77, 78. As a result, even if we assume that a
`person of ordinary skill in the art reading the ’590 Application would have
`understood “image-guided radiation therapy” (Ex. 1210, 6:14–15), “guiding
`radiation therapy on a medical linear accelerator” (id. at 31:6–7), “on-line
`imaging and guidance” (id. at 1:19), “on-line tomographic guida
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