Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 82
`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 IPR2016-00160
`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 82
`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 IPR2016-00160
`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
`
`
`
`
`
`
`
`
`IPR2016-00160
`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 1–14, 16–29, 33, and 35–38 of U.S. Patent
`No. 6,842,502 B2 (Ex. 1001, “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 1–14,
`16–29, 33, and 35–38 on the sole ground 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 53, “Pet. Reply”). Petitioner relies on the Declarations of James
`Balter, Ph.D. (Exs. 1002, 1500). Patent Owner relies on the Declaration of
`Ali Bani-Hashemi, Ph.D. (Ex. 2080). Patent Owner also filed a Motion to
`Exclude (Paper 62, “PO Mot.”), to which Petitioner filed an Opposition
`(Paper 68, “Pet. Opp.”) and Patent Owner filed a Reply (Paper 72, “PO
`Reply”).
`An oral hearing was held on January 31, 2017. Paper 79 (“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 78.
`
`
`1 Patent Owner’s Motion to Seal (Paper 26) was granted in our Order of
`January 3, 2017 (Paper 58). Unless otherwise indicated, all references
`herein to the Patent Owner Response will be to the public version
`(Paper 25).
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`Patent Owner filed a Response (Paper 80) and Petitioner filed a Response
`(Paper 81).
`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., 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-
`00162, IPR2016-00163, 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. 1001, 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. 1001,
`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. 1001, 19:64–67. X-
`ray tube 402 generates beam of x-rays 407 in a form of a cone or pyramid.
`Ex. 1001, 19:67–20:2. Flat-panel imager 404 employs amorphous silicon
`detectors. Ex. 1001, 20:6–7.
`
`Illustrative Claim
`D.
`Petitioner challenges claims 1–14, 16–29, 33, and 35–38 of the ’502
`Patent. Claim 1 is the only independent claim, and is reproduced below:
`1.
`A radiation therapy system comprising:
`a radiation source that moves about a path and directs a
`beam of radiation towards an object;
`a cone-beam computed tomography system comprising:
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`an x-ray source that emits an x-ray beam in a cone-
`beam form towards said object;
`a flat-panel imager receiving x-rays after they pass
`through the object, said imager providing 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; and
`a computer connected to said radiation source and
`said cone beam computed tomography system, 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.
`Instituted Ground of Unpatentability
`E.
`We instituted inter partes review of claims 1–14, 16–29, 33, and 35–
`38 of the ’502 patent under 35 U.S.C. § 103(a) as obvious over a
`combination of Jaffray 1999 SPIE,2 Jaffray 1999 JRO,3 Adler,4 and Depp5.
`Dec. 22–23.
`
`II. ANALYSIS
`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.,
`
`
`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. 1005,
`“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. 1006, “Jaffray 1999 JRO”).
`4 U.S. Patent No. 5,207,223, issued May 4, 1993 (Ex. 1003).
`5 U.S. Patent No. 5,427,097, issued June 27, 1995 (Ex. 1004).
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`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 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). 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. 12–16. In our Decision on Institution, we
`determined that it was necessarily to construe only “three dimensional
`information” and “a computer . . . that controls said path of said radiation
`source.” Dec. 6–9. Patent Owner agrees with our determination that “a
`computer . . . that controls said path of said radiation source” should not be
`construed as a means-plus-function limitation in accordance with § 112 ¶ 6
`(PO Resp. 15–18), but contests our construction of “three-dimensional
`information” (id. at 12–15). Specifically, Patent Owner contends that
`“three-dimensional information” must be construed in the context of the
`claim phrase “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.” Id. at 12–15. Patent Owner also offers
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`constructions for “radiation therapy system” and “cone-beam computed
`tomography system.” Id. at 10–11.
`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
`said path of said radiation source.” Paper 78. Both parties submitted
`briefing. Papers 80, 81.
`For purposes of this Decision, we determine that it is necessary to
`construe only (1) the claim phrase containing “three-dimensional
`information;” and (2) “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.”
`
`1. “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”
`Independent claim 1 recites “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.” Petitioner asserts
`that “three-dimensional information” should be construed as “information
`concerning three dimensions of an object (such as length, width, and
`depth).” Pet. 13–14 (citing Ex. 1001, 3:40–43; Ex. 1002 ¶ 37); Pet. Reply
`1–4 (citing Exs. 1500 ¶¶ 7–196; 1502, 78:22–80:16, 83:14–87:11, 135:10–
`
`
`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 61) and Petitioner’s Response to Patent Owner’s Motion for
`Observations on Cross-Examination (Paper 69).
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`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. 12–15
`(citing Ex. 1001, 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 ¶¶ 90–95). 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
`
`7 In the Decision on Institution, we preliminarily agreed with Petitioner’s
`proposed construction of “three-dimensional information.” Dec. 6–7.
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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. “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”
`Independent claim 1 recites “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.”
`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 81, 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.” Paper 80, 5.
`Both parties agree that this construction is supported by both the
`intrinsic evidence and the extrinsic evidence. Paper 81, 1–5 (citing
`Ex. 1001, Abstract, 4:57–62, claim 1, claim 34; Ex. 1500 ¶¶ 32–34;
`Ex. 1502, 120:14–121:11; Ex. 2080 ¶¶ 61–65, 99, 112–116, 127); Paper 80,
`1–5 (citing Ex. 1001, 26:39–55, claim 1; Ex. 1011, 125–26; Tr. 31:1–33:13;
`Ex. 2080 ¶ 99; Ex. 2084, WBH_Elekta_01892, WBH_Elekta_01922,
`WBH_Elekta_01950, WBH_Elekta_01973). In particular, both parties
`agree that claim 1 is open-ended and non-limiting, and is necessarily broader
`than dependent claim 34, which specifies that the recited control of said
`radiation path is “in an automatic manner without human intervention.”
`We agree. We, therefore, construe “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” to
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`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. 1002 ¶ 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
`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.
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`C. Whether Jaffray 1999 SPIE and Jaffray 1999 JRO
` are Prior Art to Claims 1–14, 16–29, 33, and 35–38
`Petitioner asserts that (1) claims 1–14, 16–29, 33, and 35–38 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)8 (Pet. 16–19; Pet. Reply 6–12); 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. 19–20; Pet. Reply 12–22).
`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. 18–31); 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
`Petitioner relies is the work of the named inventors of the ’502 Patent, not of
`the coauthors not named as inventors (id. at 32–41).
`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
`
`8 All references to 35 U.S.C. §§ 102, 103 herein will be pre-AIA.
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`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) 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.” In re Fong, 378 F.2d
`977, 980 (CCPA 1967); see also In re Land, 368 F.2d 866, 877 (CCPA
`1966) (“There appears to be no dispute as to the law that A 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
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`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 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 claim 1 was 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. 16–20. Specifically,
`Petitioner asserts that the ’590 Application does not provide sufficient
`written description support for “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 in independent
`claim 1, 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 16–17; see also id. at 18
`(“One of ordinary skill in the art, reviewing the ’590 [Application], would
`not have recognized that the applicants possessed the invention they
`claimed.”). As a result, according to Petitioner, the effective date of
`independent claim 1 is February 16, 2001, the filing date of U.S. Application
`No. 09/788,335, which issued as the ’502 Patent. Id. at 18. 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 19.
`The burden of production having shifted to Patent Owner, Patent
`Owner asserts that independent claim 1 is entitled to the benefit of priority of
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`the ’590 Application, because the ’590 Application provides sufficient
`written description support for the disputed limitation in independent
`claim 1. PO Resp. 19–31 (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
`limitation of independent claim 1.
`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. 1009,
`7:13–16); “the host computer advances the motorized rotation stage”
`(Ex. 1009, 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. 1009,
`6:11–15). PO Resp. 23–24. 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:
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`Id. at 23.
`Patent Owner also argues that “[a person of ordinary skill in the art]
`would have recognized that disclosure of a conventional medical linear
`accelerator at the time of the invention expressly disclosed a linear
`accelerator that operates its components under computer control” (PO
`Resp. 28), and that “a [person of ordinary skill in the art] would have
`recognized that the disclosed drum-based Elekta 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. 28 (citing
`Ex. 2080 ¶¶ 61–65, 115–116, 127); see also id. at 29–30 (citing Ex. 2080
`¶¶ 69, 112, 117–119). As a result, according to Patent Owner, a person of
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`ordinary skill in the art would have understood the ’590 Application’s
`disclosure of “image-guided radiation therapy” (Ex. 1009, 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. 26–27. 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 CBCT-FPI images (Ex. 2080 ¶ 107; Ex.
`1009 at 011) and a translatable treatment couch for positioning
`the patient based on the images, a [person of ordinary skill in the
`art] 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. (Ex. 2080 ¶¶ 59–60, 129). Moreover, processes for
`registering and comparing such 3-D images were known in the
`art prior to the date of the invention. (Id. ¶ 60; see also Ex. 2089;
`Ex. 2090). Petitioner’s argument improperly ignores the state of
`the art at the time of the invention. Capon, 418 F.3d at 1357-58.
`Id. at 30.
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`We find that Patent Owner has produced sufficient evidence to have
`met its burden of production, and the burdens9 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 limitation, because those terms would not
`necessarily have implied, to a person of ordinary skill in the art, the use of a
`computer for control the path of a radiation source. Pet. Reply 7–8.
`According to Petitioner, “[i]t is undisputed that the path of the radiation
`source can be controlled by manual means in which a human operator, not a
`computer, performs the tasks of image analysis and determination of path
`control based on the image.” Id. at 8; see also id. at 9–10 (arguing that
`known adjustment of beam position, in real time, based on imaging was
`“manual and unaided by computer control of beam path based on imaging”
`and that, “‘computer-controlled’ treatment tables . . . are irrelevant . . . since
`the claims require that a computer must perform the function of path control
`based on the received image.”).
`Having considered the arguments and evidence, we agree with Patent
`Owner that the ’590 Application provides sufficient written description
`support for “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.” 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
`
`
`9 Both the burden of production and the burden of persuasion.
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`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 they are based upon
`a construction of the disputed limitation that excludes human intervention.
`We have construed that limitation, however, 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 80, 81. As a result, even if we assume, as Petitioner contends in
`Reply, that a person of ordinary skill in the art reading the ’590 Application
`would have understood that “the step of controlling the path of the beam
`based on image data was performed by a human operator, not a computer
`acting autonomously” (Pet. Reply 9) and that “[t]he computer elements
`connected to table control . . . are all operated in response to commands
`received from a human operator, and none are tied to table movements
`specifically based on image data” (id.), it would not show a lack of support
`for the disputed limitation, because the disputed limitation does not exclude
`human intervention.
`Accordingly, we determine that Petitioner has not shown sufficiently,
`on this record, that both Jaffray 1999 SPIE and Jaffray 1999 JRO are prior
`art to independent claim 1, and the challenged claims that depend therefrom,
`under 35 U.S.C. § 102(b).
`3. Whether Jaffray 1999 SPIE, Jaffray 1999 JRO are Prior
`Art under 35 U.S.C. § 102(a)
`Again applying the framework from Dynamic Drinkware, we
`determine that Petitioner has met its initial burden of production by asserting
`that each of Jaffray 1999 SPIE and Jaffray 1999 JRO are prior art under
`35 U.S.C. § 102(a). Pet. 19 (“at a minimum, the Jaffray 1999 references are
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`prior art under § 102(a) (pre-AIA) because each published before
`February 18, 2000, the filing date of the earliest application appearing on the
`face of the ’502 Patent”). Specifically, Jaffray 1999 SPIE lists a co-author,
`“D.G. Drake” (Ex. 1005, 016) who is not a named inventor of the ’502
`patent, and Jaffray 1999 JRO lists three co-authors, Douglas G. Drake,
`Michel Moreau, and Alvaro A. Martinez (Ex. 1006, 003), who are not
`named inventors of the ’502 patent.
`The burden of production having shifted to Patent Owner, Patent
`Owner asserts that Jaffray 1999 SPIE and Jaffray 1999 JRO are not prior art
`under 35 U.S.C. § 102(a), because the portions on which Petitioner relies are
`not th
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