`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`ELEKTA INC.,
`Petitioner
`v.
`BEST MEDICAL INTERNATIONAL, INC.,
`Patent Owner.
`___________________
`Case No.: IPR2020-00067
`U.S. Patent No. 7,015,490
`___________________
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 7,015,490
`
`
`
`
`
`Petition for IPR of U.S. Patent 7,015,490
`
`TABLE OF CONTENTS
`
`
`I.
`
`IV.
`
`INTRODUCTION ......................................................................................... 1
`A. Declaration Evidence .......................................................................... 1
`II. MANDATORY NOTICES UNDER 37 C.F.R. §42.8(a)(1) ....................... 2
`A. Real Parties-in-Interest (37 C.F.R. §42.8(b)(1)) ............................... 2
`B.
`Related Matters (37 C.F.R. §42.8(b)(2)) ............................................ 2
`C. Counsel (37 C.F.R. §42.8(b)(3)) and Service Information (37
`C.F.R. §42.8(b)(3)-(4)) ......................................................................... 2
`III. CERTIFICATION (37 C.F.R. §42.104(A)) AND PAYMENT OF FEES
`(37 C.F.R. §42.10) .......................................................................................... 3
`IDENTIFICATION OF CLAIMS AND GROUNDS (37 C.F.R.
`§42.104(a),(B)) ................................................................................................ 4
`A.
`Patents and Patent Applications ........................................................ 4
`B.
`Non-Patent Literature ......................................................................... 5
`1.
`Chang 2000 (Ex. 1007) .............................................................. 6
`2.
`Chang 2001 (Ex. 1009) .............................................................. 7
`3.
`Siochi 1999 (Ex. 1011) ............................................................... 7
`4.
`Boyer 2001 (Ex. 1013) ............................................................... 8
`5. Webb 1993 (Ex. 1018) ............................................................... 8
`6. Webb 2001 (Ex. 1016) ............................................................... 9
`TECHNOLOGY BACKGROUND ............................................................10
`V.
`VI. BACKGROUND ..........................................................................................14
`A. Overview of the ’490 Patent .............................................................14
`
`
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` Petition for IPR of U.S. Patent 7,015,490
`
`Relevant Prosecution History ...........................................................16
`B.
`C. Cited References ................................................................................17
`1.
`Chang 2000 ..............................................................................17
`2.
`Chang 2001 ..............................................................................18
`3.
`Siochi 1999 ...............................................................................19
`4.
`Boyer 2001 ...............................................................................20
`5.
`Siochi ’355 ................................................................................20
`6. Webb 1993 ...............................................................................21
`7. Webb 2001 ...............................................................................21
`VII. PERSON OF ORDINARY SKILL IN THE ART (“POSITA”) .............22
`VIII. CLAIM CONSTRUCTION (37 C.F.R. §42.104(B)(3)) ............................23
`IX. GROUND #1: CHANG 2000 IN VIEW OF CHANG 2001, IN
`FURTHER VIEW OF BOYER 2001 .........................................................25
`A. Claim 1. “A computer-implemented method of determining a
`collimator angle of a multi-leaf collimator having an opening and
`a plurality of multi-leaf collimator leaf pairs for closing portions
`of the opening to form a radiation beam arrangement having a
`plurality of radiation beam segments to apply radiation to a
`tumor target, the method comprising the steps of...” ....................25
`Claim 10. “A method of determining a collimator angle of a multi-
`leaf collimator having an opening and a plurality of multi-leaf
`collimator leaf pairs for closing portions of the opening to form a
`radiation beam arrangement having a plurality of radiation beam
`segments to apply radiation to a tumor target, the method
`comprising the steps of:” ..................................................................29
`C. Claim 11. “A method as defined in claim 10, wherein…” .............33
`D. Claim 17. “An apparatus for use in conformal radiation therapy
`of a target tumor, the apparatus comprising:” ..............................33
`
`B.
`
`
`
`ii
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` Petition for IPR of U.S. Patent 7,015,490
`
`
`
`X. GROUND #2: CHANG 2000 IN VIEW OF CHANG 2001, IN
`FURTHER VIEW OF SIOCHI 1999, IN FURTHER VIEW OF
`BOYER 2001 ................................................................................................36
`A. Claim 4. “A method as defined in claim 1, further comprising the
`step of…” ............................................................................................36
`Claim 12. “A method as defined in claim 11, wherein…” .............37
`B.
`C. Claim 18. “An apparatus as defined in claim 17, wherein…” ......40
`D. Claim 19. “An apparatus as defined in claim 18, wherein…” ......41
`XI. GROUND # 3: SIOCHI ’355 IN VIEW OF WEBB 2001, IN FURTHER
`VIEW OF SIOCHI 1999 .............................................................................42
`A. Claim 1. “A computer-implemented method of determining a
`collimator angle of a multi-leaf collimator having an opening and
`a plurality of multi-leaf collimator leaf pairs for closing portions
`of the opening to form a radiation beam arrangement having a
`plurality of radiation beam segments to apply radiation to a
`tumor target, the method comprising the steps of…” ...................42
`Claim 4. “A method as defined in claim 1, further comprising the
`step of…” ............................................................................................47
`C. Claim 10. “A method of determining a collimator angle of a multi-
`leaf collimator having an opening and a plurality of multi-leaf
`collimator leaf pairs for closing portions of the opening to form a
`radiation beam arrangement having a plurality of radiation beam
`segments to apply radiation to a tumor target, the method
`comprising the steps of” ....................................................................48
`D. Claim 11. “A method as defined in claim 10, wherein…” .............52
`E.
`Claim 17. “An apparatus for use in conformal radiation therapy
`of a target tumor, the apparatus comprising…” ............................52
`Claim 18. “An apparatus as defined in claim 17, wherein…” ......57
`F.
`XII. GROUND #4: SIOCHI ’355 IN VIEW OF WEBB 2001 AND SIOCHI
`1999, IN FURTHER VIEW OF WEBB 1993 ...........................................58
`
`B.
`
`
`
`iii
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` Petition for IPR of U.S. Patent 7,015,490
`
`A. Claim 12. “A method as defined in claim 11, wherein…” .............58
`B.
`Claim 19. “An apparatus as defined in claim 18, wherein…” ......59
`XIII. MOTIVATION TO COMBINE CITED REFERENCES .......................60
`A. Grounds I and II ................................................................................60
`A. Grounds III and IV ...........................................................................62
`XIV. SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS DO
`NOT NEGATE OBVIOUSNESS ...............................................................63
`XV. SUMMARY CHARTS ................................................................................64
`A.
`Identification of Where Each Limitation of the Challenged Claims
`is Found in the Cited References .....................................................64
`XVI. CONCLUSION ............................................................................................65
`
`
`
`
`
`
`iv
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`Petition for IPR of U.S. Patent 7,015,490
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Chore-Time Equip., Inc. v. Cumberland Corp., 713 F.2d 774 (Fed.
`Cir. 1983) ............................................................................................................ 22
`In re Cronyn, 890 F.2d 1158 (Fed. Cir. 1989) ........................................................... 6
`GoPro, Inc. v. Contour IP Holding LLC, 898 F.3d 1170 (Fed. Cir.
`2018) (opinion modified on other grounds) ......................................................... 5
`In re Hall,781 F.2d 897 (Fed. Cir. 1986) ................................................................... 6
`LG Elec., Inc. v. Advanced Micro Devices, Inc., IPR2015-00329,
`Paper 13 (PTAB Jul. 10, 2015) ................................................................. 6, 7, 8, 9
`Okajima v. Bourdeau, 261 F.3d 1350 (Fed. Cir. 2001) ........................................... 22
`Spitzer v. Aljoe, No. 13-cv-05442-MEJ, 2016 WL 3275148 (N.D. Cal.
`Jun. 15, 2016) .......................................................................................... 6, 8, 9, 10
`Voter Verified, Inc. v. Premier Election Solutions, Inc., 698 F.3d 1374
`(Fed. Cir. 2012) ............................................................................................. 6, 8, 9
`Statutes
`35 U.S.C. 315(e) ........................................................................................................ 2
`35 U.S.C. §§311-319.................................................................................................. 1
`
`
`
`
`
`
`Petition for IPR of U.S. Patent 7,015,490
`
`LIST OF EXHIBITS
`
`
`Exhibit Description
`U.S. Patent No. 7,015,490. (“’490 patent”)
`1001
`Prosecution History of U.S. Patent Application No. 10/915,968, which
`1002
`matured into U.S. Patent No. 7,015,490.
`Declaration of Arthur L. Boyer, PhD.
`US Patent No. 5,596,619. (“’619 patent”)
`US Patent No. 5,802,136. (“’136 patent”)
`Brahme, A. (1988). Optimal setting of multileaf collimators in
`stationary beam radiation therapy. Strahlentherapie und Onkologie:
`Organ der Deutschen Rontgengesellschaft...[et al], 164(6), 343-350.
`(“Brahme 1988b”)
`Chang, S. X., Cullip, T. J., & Deschesne, K. M. (2000). Intensity
`modulation delivery techniques:“Step & shoot” MLC auto‐sequence
`versus the use of a modulator. Medical physics, 27(5), 948-959.
`(“Chang 2000”)
`AAPM Online Publication History of Chang 2000,
`https://aapm.onlinelibrary.wiley.com/toc/24734209/2000/27/5.
`Chang, S. X., & Potter, L. D. (2001). An iterative “Step & Shoot”
`MLC-IMRT segmentation algorithm for continuous intensity
`maps. International Journal of Radiation Oncology• Biology•
`Physics, 51(3), 408. (“Chang 2001”)
`International Journal of Radiation Oncology•Biology•Physics Online
`publication history of Chang 2001,
`https://www.redjournal.org/article/S0360-3016(01)02575-5/abstract.
`Siochi, R. A. C. (1999). Minimizing static intensity modulation
`delivery time using an intensity solid paradigm. International Journal
`of Radiation Oncology* Biology* Physics, 43(3), 671-680. (“Siochi
`1999”)
`International Journal of Radiation Oncology* Biology* Physics Online
`Publication History of Siochi 1999.
`https://www.sciencedirect.com/science/article/pii/S0360301698004301
`Boyer, A., Biggs, P., Galvin, J., Klein, E., LoSasso, T., Low, D., ... &
`Yu, C. (2001). Basic applications of multileaf collimators: report of
`Task Group No 50, Radiation Therapy Committee. American Institute
`of Physics for the AAPM, New York, NY. (“Boyer 2001”)
`Online Publication History of Boyer 2001.
`US Patent No. 6,757,355. (“Siochi ’355”)
`
`1003
`1004
`1005
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`1015
`
`
`
`
`
`
`
` Petition for IPR of U.S. Patent 7,015,490
`
`1017
`
`1018
`
`1019
`
`Exhibit Description
`Webb, S. (2001). A simple method to control aspects of fluence
`1016
`modulation in IMRT planning. Physics in Medicine & Biology, 46(7),
`N187. (“Webb 2001”)
`Physics in Medicine and Biology Online Publication History of Webb
`2001, https://iopscience.iop.org/article/10.1088/0031-
`9155/46/7/403/meta.
`Webb, S. (1993). The physics of three dimensional radiation therapy:
`Conformal radiotherapy, radiosurgery and treatment planning. CRC
`Press. (“Webb 1993”)
`CRC Press. Publication information for Webb 1993.
`https://www.crcpress.com/The-Physics-of-Three-Dimensional-
`Radiation-Therapy-Conformal-
`Radiotherapy/Webb/p/book/9780750302548.
`Karzmark, C. J., & Morton, R. J. (1981). Primer on theory and
`operation of linear accelerators in radiation therapy (No. FDA--82-
`8181). Bureau of Radiological Health. (“Karzmark 1981”)
`1990s State of the Art Declaration – Arthur L. Boyer.
`CV of Arthur L. Boyer.
`Declaration of Marla Hirth
`Google Scholar Report for Chang 2000 (date limited: -2002).
`Google Scholar Report for Boyer 2001 (date limited: -2002).
`Google Scholar Report for Siochi 1999 (date limited: -2002).
`Google Scholar Report for Webb 1993 (date limited: -2002).
`Google Scholar Report for Webb 2001 (date limited: -2002).
`US Patent No. 6,314,159 (“Siochi ’159 2001”).
`
`
`1020
`
`1021
`1022
`1023
`1024
`1025
`1026
`1027
`1028
`1029
`
`vii
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`
`
`I.
`
`Petition for IPR of U.S. Patent 7,015,490
`
`INTRODUCTION
`Elekta Inc. (“Elekta” or “Petitioner”) requests that the Board institute inter
`
`partes review (“IPR”) of and cancel claims 1, 4, 10-12, 17-19 (“Challenged Claims”)
`
`of U.S. Patent No. 7,015,490 (“the ’490 patent”) (Ex. 1001), assigned to Best
`
`Medical International, Inc. (“BMI” or “Patent Owner”), in accordance with 35
`
`U.S.C. §§311-319 and 37 C.F.R. §42.100 et seq.
`
`A. Declaration Evidence
`This Petition is supported by declaration testimony of Dr. Arthur L. Boyer
`
`(“Boyer Declaration,” Ex. 1003, “Boyer SOA Declaration,” Ex. 1021 and “Hirth
`
`Declaration,” Ex. 1023). Boyer Declaration describes the ’490 patent, the person of
`
`ordinary skill in the art in the relevant time frame, interpretation of certain terms in
`
`the ’490 patent, the state of the art of the ’490 patent, the scope and content of the
`
`prior art compared to the claims of the ’490 patent, and the rationales for combining
`
`prior art elements. Boyer SOA Declaration describes the state of the art of
`
`radiotherapy in the 1990s. Hirth Declaration describes the public availability and
`
`authenticity of the cited references.
`
`
`
`
`
`
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. §42.8(A)(1)
`A. Real Parties-in-Interest (37 C.F.R. §42.8(b)(1))
`
` Petition for IPR of U.S. Patent 7,015,490
`
`Petitioner identifies Elekta Limited (UK), Elekta Holdings U.S., Inc. and
`
`Elekta AB as real parties in interest without admitting that they are in fact real parties
`
`in interest. Elekta Limited (UK), Elekta Holdings U.S., Inc. and Elekta AB have
`
`agreed to be bound by the estoppel provisions of 35 U.S.C. 315(e) to the same extent
`
`as Petitioners.
`
`B. Related Matters (37 C.F.R. §42.8(b)(2))
`
`Patent Owner asserted the ’490 Patent in Best Medical International, Inc. v.
`
`Elekta Inc. and Elekta Limited, Civil Action 1:19-cv-03409-MLB (currently pending
`
`in the Northern District of Georgia, and previously pending in the District of
`
`Delaware as Civil Action No. 1:18-cv-01600-MN) and Best Medical International,
`
`Inc. v. Varian Medical Systems, Inc. et al, Civil Action 1:18-cv-01599 (currently
`
`pending in the District of Delaware).
`
`C. Counsel (37 C.F.R. §42.8(b)(3)) and Service Information (37
`C.F.R. §42.8(b)(3)-(4))
`
`Petitioner designates Tamara D. Fraizer (Reg. No. 51,699) as lead counsel for
`
`this matter. Petitioner designates Christopher W. Adams (Reg. No. 62,550) and Vid
`
`R. Bhakar (Reg. No. 42,323) as back-up counsel for this matter.
`
`
`
`2
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`
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` Petition for IPR of U.S. Patent 7,015,490
`
`Postal mailings and hand-deliveries for lead and back-up counsel should be
`
`addressed to: Tamara D. Fraizer, Squire Patton Boggs (US) LLP, 1801 Page Mill
`
`Road, Suite 110, Palo Alto, CA 94304-1043 (Telephone: (650) 843-3201; Fax: (650)
`
`843-8777).
`
`Pursuant to 37 C.F.R. §42.8(b)(4), Petitioner consents to e-mail service at:
`
`tamara.fraizer@squirepb.com; sfripdocket@squirepb.com.
`
`For compliance with 37 C.F.R. §42.10(b), a Power of Attorney is also filed
`
`Concurrently herewith.
`
`III. CERTIFICATION (37 C.F.R. §42.104(A)) AND PAYMENT OF FEES
`(37 C.F.R. §42.10)
`Petitioner certifies that the ’490 patent is available for IPR, and Petitioner and
`
`the real parties-in-interest are not barred or estopped from requesting IPR on the
`
`grounds identified herein.
`
`The complaint referenced in Section II.B was served within the last 12
`
`months. Neither the Petitioner nor its real parties-in-interest (or privies) have been
`
`served with any other complaint alleging infringement of the ’490 patent.
`
`The undersigned authorizes the USPTO to charge any fees due during this
`
`proceeding to Deposit Account No. 07-1850.
`
`
`
`3
`
`
`
`
`
`IV.
`
` Petition for IPR of U.S. Patent 7,015,490
`
`IDENTIFICATION OF CLAIMS AND GROUNDS (37 C.F.R.
`§42.104(A),(B))
`The application for the ’490 patent was filed on August 11, 2004 by Nomos
`
`Corporation, the Patent Owner’s predecessor-in-interest. The application claimed
`
`priority to U.S. Provisional Application No. 60/494,222, filed on August 11, 2003.
`
`Ex. 1002 at 6.
`
`Because the filing date of the ’490 patent (and all applications to which it
`
`claims priority) is before the effective date of the AIA (March 16, 2013), the pre-
`
`AIA statute applies.
`
`For purposes of this IPR, Petitioner treats August 11, 2003, the effective filing
`
`date of the cited provisional applications, as the “Alleged Priority Date” for all
`
`Challenged Claims. To the extent that the Patent Owner demonstrates a date of
`
`conception earlier than this, the Petitioner reserves the right to adjust the “Alleged
`
`Priority Date” accordingly.
`
`Petitioner relies on the following references.
`
`Patents and Patent Applications
`
`A.
`Siochi ’355 (Ex. 1015). Issued as US Patent No. 6,757,355 on June 29, 2004.
`
`Siochi ’355 is prior art under §102(e).
`
`
`
`4
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`
`
`
`
`
`B. Non-Patent Literature
`
` Petition for IPR of U.S. Patent 7,015,490
`
`Whether a reference constitutes a printed publication under §102(b) is a legal
`
`conclusion based on underlying factual determinations. GoPro, Inc. v. Contour IP
`
`Holding LLC, 898 F.3d 1170, 1173-74 (Fed. Cir. 2018) (opinion modified on other
`
`grounds). The Federal Circuit has “interpreted §102 broadly, finding that even
`
`relatively obscure documents qualify as prior art so long as the relevant public has a
`
`means of accessing them.” Id. at 1174. A reference is “publicly accessible if it was
`
`disseminated or otherwise made available to the extent that persons interested and
`
`ordinarily skilled in the subject matter or art exercising reasonable diligence, can
`
`locate it.” Id.
`
`Chang 2000, Chang 2001, Siochi 1999, Webb 1993 and Webb 2001 are
`
`authentic copies of the references from their respective publications or books located
`
`at either the National Library of Medicine or the Library of Congress. Exs. 1007,
`
`1009, 1011, 1018 and 1016. Each of the aforementioned references also bears a
`
`sticker and/or stamp from each of these institutions indicating the institutions name
`
`and the date the reference was received at the library. Id.; see also Ex. 1023 at ¶¶17-
`
`37 and 44-110. Each of the aforementioned dates were prior to the Alleged Priority
`
`Date. Id. Courts have held that papers that are catalogued and available to the public
`
`in libraries, including the Library of Congress, are sufficiently “publicly available”
`
`
`
`5
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`
`
`
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`or “publicly accessible” to serve as prior art. See, e.g., In re Hall, 781 F.2d 897 (Fed.
`
` Petition for IPR of U.S. Patent 7,015,490
`
`Cir. 1986); In re Cronyn, 890 F.2d 1158, 1161 (Fed. Cir. 1989).
`
`1.
`
`Chang 2000 (Ex. 1007)
`
`Chang 2000 is a printed publication bearing a copyright date of 2000, first
`
`published by the American Association of Physicists in Medicine (“AAPM”) in the
`
`International Journal of Medical Physics Research and Practice (“Medical Physics”).
`
`Ex. 1007 at cover page; LG Elec., Inc. v. Advanced Micro Devices, Inc., IPR2015-
`
`00329, Paper 13 at 12 (PTAB Jul. 10, 2015) (copyright date is prima facie evidence
`
`of publication).
`
`Chang 2000 includes other indicia of its public accessibility, including
`
`National Library of Medicine (NLM) and Library of Congress (LOC) publication
`
`data (Ex. 1023 at ¶¶22-23) and publisher information, showing this article was
`
`available for online download on “May 5, 2000.” Ex. 1008 (“Issue Online: 05 May
`
`2000”); Voter Verified, Inc. v. Premier Election Solutions, Inc., 698 F.3d 1374, 1380
`
`(Fed. Cir. 2012) (online article qualified as a §102(b) “printed publication” because
`
`interested and skilled persons could have located it).
`
`Chang 2000 was cited by other references prior to the Alleged Priority Date.
`
`Ex. 1023 at ¶24. See also Spitzer v. Aljoe, No. 13-cv-05442-MEJ, 2016 WL 3275148
`
`at *3 (N.D. Cal. Jun. 15, 2016) (taking judicial notice of the publicly availability of
`
`a document located on Google Scholar).
`
`
`
`6
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` Petition for IPR of U.S. Patent 7,015,490
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`Thus, Chang 2000 is §102(b) prior art, publically accessible at least a year
`
`before the Alleged Priority Date.
`
`2.
`
`Chang 2001 (Ex. 1009)
`
`Chang 2001 is a printed abstract first published by the American Society for
`
`Radiation Oncology (“ASTRO”) in “Volume 51, Number 3, Supplement 1, 2001”
`
`of the International Journal of Radiation Oncology·Biology·Physics (“Astro
`
`Journal”). Chang 2001 has a copyright date of 2001 on its publisher’s website. Ex.
`
`1009 at cover page; see also LG Elec., Inc., IPR2015-00329, Paper 13 at 12 (PTAB
`
`Jul. 10, 2015).
`
`Thus, Chang 2001 is §102(b) prior art, publically accessible a year before the
`
`Alleged Priority Date.
`
`3.
`
`Siochi 1999 (Ex. 1011)
`
`Siochi 1999 is a printed publication bearing a copyright date of 1999 and first
`
`published by Elsevier Inc.in “Volume 43, Issue 3…1999” of the Astro Journal. Ex.
`
`1011 at cover page; see also LG Elec., Inc., IPR2015-00329, Paper 13 at 12 (PTAB
`
`Jul. 10, 2015).
`
`Siochi 1999 includes other indicia of its public accessibility, including NLM
`
`and LOC publication data (Ex. 1023 at ¶¶35-36) and publisher information, which
`
`shows that this article was available for online download on “19 February 1999.”
`
`
`
`7
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`
`
`
`
`Ex. 1012 (“Available online 19 February 1999”; see also Voter Verified, Inc., at 698
`
` Petition for IPR of U.S. Patent 7,015,490
`
`F.3d 1380.
`
`Siochi 1999 was cited by other references prior to the Alleged Priority Date.
`
`Ex. 1023 at ¶37. See also Spitzer at *3.
`
`Thus, Siochi 1999 is §102(b) prior art, publically accessible a year before the
`
`Alleged Priority Date.
`
`4.
`
`Boyer 2001 (Ex. 1013)
`
`Boyer 2001 is a book bearing a copyright date of 2001 that was first published
`
`by Medical Physics Publishing in “July 2001” for AAPM. Ex. 1013 at cover page,
`
`page 2; see also LG Elec., Inc., IPR2015-00329, Paper 13 at 12 (PTAB Jul. 10,
`
`2015).
`
`Boyer 2001 includes other indicia of its public accessibility and publisher
`
`information, which shows that this book was published in July 2001. Ex. 1014.
`
`Boyer 2001 was cited by other references prior to the Alleged Priority Date.
`
`Ex. 1023 at 43. See also Spitzer at *3.
`
`Thus, Boyer 2001 is §102(b) prior art, publically accessible a year before the
`
`Alleged Priority Date.
`
`5. Webb 1993 (Ex. 1018)
`Webb 1993 is a book bearing a copyright date of 1993 that was first published
`
`by IOP Publishing Ltd. Ex. 1018 at page 2;see also LG Elec., Inc., IPR2015-00329,
`
`
`
`8
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`
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`Paper 13 at 12 (PTAB Jul. 10, 2015).Webb 1993 includes other indicia of its public
`
` Petition for IPR of U.S. Patent 7,015,490
`
`accessibility, including NLM and LOC publication data (Ex. 1023 at ¶¶58-59) and
`
`publisher information, which shows that this book was “published” as an “eBook”
`
`on “1 January 1993” and was thus available for online download on or around that
`
`date. Ex. 1019; see also Voter Verified, Inc., at 698 F.3d 1380.
`
`Webb 1993 was cited by other references prior to the Alleged Priority Date.
`
`Id. Ex. 1023 at ¶60. See also Spitzer at *3. Petitioner’s expert, Arthur L. Boyer, was
`
`one of the co-authors of the latter article and recalls reviewing Webb 1993 in
`
`advance of the Alleged Priority Date.
`
`Thus, Webb 1993 is §102(b) prior art, publically accessible a year before the
`
`Alleged Priority Date.
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`6. Webb 2001 (Ex. 1016)
`Webb 2001 is a printed publication bearing a copyright date of 2001 and first
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`published by IOP Publishing Ltd. in the United Kingdom in “July 2001.” Ex. 1016
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`at cover page (“July 2001”); see also LG Elec., Inc., IPR2015-00329, Paper 13 at 12
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`(PTAB Jul. 10, 2015).
`
`Webb 2001 includes other indicia of its public accessibility, including LOC
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`publication data (Ex. 1023 at ¶48) and publisher information, which shows that this
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`article was received for publication on “9 April 2001” Ex. 1017.
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`
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`9
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`
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` Petition for IPR of U.S. Patent 7,015,490
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`Webb 2001 was cited by other references prior to the Alleged Priority Date.
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`Ex. 1023 at ¶49. See also Spitzer at *3.
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`Thus, Webb 2001 is §102(b) prior art, publically accessible a year before the
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`Alleged Priority Date.
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`
`
`Petitioner submits the Challenged Claims are unpatentable on the following
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`grounds:
`
`Ground Statutory Basis and Art Cited
`
`Claims
`
`1, 10, 11, 17
`
`I
`
`II
`
`III
`
`VI
`
`§103 – obvious over Chang 2000 in view of Chang
`2001, in further view of Boyer 2001.
`
`§103 – obvious over Chang 2000 in view of Chang
`2001, in further view of Siochi 1999, and Boyer 2001.
`
`4, 12, 18, 19
`
`§103 – obvious over Siochi ’355 in view of Webb 2001,
`in further view of Siochi 1999
`
`1, 4, 10, 11,
`17, 18
`
`§103 – obvious over Siochi ’355 in view of Webb 2001
`and Siochi 1999, in further view of Webb 1993.
`
`12, 19
`
`V. TECHNOLOGY BACKGROUND
`The Challenged Claims relate to optimization of radiotherapy treatment plans
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`delivered by a medical linear accelerator (“LINAC”). Ex. 1021 at ¶¶10-88.
`
`A radiotherapy treatment machine includes a LINAC and a multi-leaf
`
`collimator (“MLC”). Id. at 15-24. The MLC is affixed to the LINAC and has several
`
`pairs of metallic leaves that can be moved to create an opening that shapes the beam
`
`of radiation as it exits the treatment machine. Id. at ¶¶34-39. Shaped beams can be
`
`
`
`10
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`
`
`
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`precisely delivered to a patient on a treatment couch from various directions. Id. at
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` Petition for IPR of U.S. Patent 7,015,490
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`¶15, Figure B. LINACs have been used to treat patients with radiation in this manner
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`since at least the early 1990s. Id. at ¶15.
`
`Such conformal radiation treatment requires developing a detailed treatment
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`plan based on three-dimensional images of the patient. Id. at ¶¶26-33, 76-80; Ex.
`
`1003 at ¶¶144-154. IMRT is a type of conformal radiation therapy that not only
`
`conforms the beam to the shape of a tumor, but also modulates the intensity of
`
`radiation delivered to the patient on a scale that is smaller than the radiation beam
`
`itself (it converts a single beam into multiple sub-beams, called beamlets), usually
`
`by delivering several differently shaped beams from each of several angles. Ex. 1021
`
`at ¶¶57-64; Ex. 1003 at ¶¶126-132, 146.
`
`IMRT treatment planning is complex, and requires use of iterative
`
`optimization to find the “best” plan, where “best” depends on the goal of the
`
`optimization. Ex. 1021, ¶71-72; Ex. 1003, ¶143-144. The goal is defined by a “cost”
`
`function, and the computer algorithms search for a solution that minimize the value
`
`of the cost function. Ex. 1021, ¶¶72, 79. Traditionally, IMRT treatment planning
`
`optimized the dose, using one cost function for the tumor and others for healthy
`
`tissues. Id., ¶¶75-76. By the late-1990s, algorithms were developed to also optimize
`
`the delivery efficiency, for example, by sequencing the MLC shapes used in the
`
`treatment. Ex. 1003 at ¶¶159-166.
`
`
`
`11
`
`
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`
`
`
` Petition for IPR of U.S. Patent 7,015,490
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`Delivery efficiency is important because patients won’t tolerate laying on the
`
`treatment table for a long time. Id., ¶158. It was understood that (all else equal) the
`
`time required to deliver an IMRT treatment plan correlated with the number of
`
`segments in the treatment plan as well as the complexity of the intensity maps. Ex.
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`1003, ¶162. It was also understood that to improve IMRT delivery efficiency, “the
`
`total leaf movement [associated with set-up of the MLC] should be minimized.” Id.,
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`¶163. This was because the time required for the leaves to move from one shape to
`
`the next was a potential limiting factor for treatment delivery. Ex. 1003 at ¶¶158-
`
`163.
`
` The ’490 patent relates to one potential aspect of IMRT treatment planning:
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`“optimization of collimator angles for [MLCs] used in intensity modulated radiation
`
`therapy treatment.” Ex. 1001 at 1:26-31. The ’490 patent presents a “cost function
`
`obtained by combining the prior algorithm based upon Brahme’s orientation theory”
`
`with a supposedly “new” second function. Ex. 1001 at 5:65 to 6:1, 6:53-56. Despite
`
`the previous statement, the ’490 patent does not identify or fully characterize the
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`paper in which Brahme presented this theory. (Ex. 1006) (“Brahme 1988b”).
`
`Brahme 1988b considered the mismatch between the MLC leaves and the
`
`outline of a tumor, as shown by the hatched areas in the figure below. Ex. 1003,
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`¶¶191-192; Ex. 1006 at 346, Figure 3.
`
`
`
`12
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` Petition for IPR of U.S. Patent 7,015,490
`
`
`
`For different orientations of an MLC against a target, Brahme 1988b determined the
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`“area difference” between the edges of the MLC leaves and the tumor, and the
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`“treated area” and the “relative mean energy imparted.” Ex. 1006 at 348. Orienting
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`the MLC leaves to align with the smallest cross-section reduced the treated area and
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`relative mean energy imparted. Id. For simple shapes, Brahme concluded “the best
`
`rotation angle . . . is obtained by aligning the direction of motion of the leaves with
`
`the direction in which the target volume has its smallest cross-section.” Id. at 347.
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`In the early 1990s, Brahme’s “area difference” metric was incorporated into
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`conformal treatment planning systems to find collimator angles that provided the
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`best match and the lowest monitor units. Ex. 1003 at ¶¶139-141. By 2002, Brahme’s
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`orientation theory was also incorporated into IMRT optimization programs that had
`
`
`
`13
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`
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`mechanisms to enhance delivery efficiency by reducing the number of segments and
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` Petition for IPR of U.S. Patent 7,015,490
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`MUs. Id. For example, (Xia 1998) discloses a sequencing algorithm that minimizes
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`treatment segments with minor increases to monitor units based on leaf motion
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`constraints and collimator angles. Id. at ¶141.
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`Also by 2002, it was known to include delivery considerations in the
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`optimization of conformity in IMRT treatment plans, for example, with a “hybrid”
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`cost function. Webb 2001 characterized conformity as an issue in “dose-space” and
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`characterized delivery efficiency as an issue in “beam-space.” Ex. 1016 at Abstract.
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`Webb 2001 taught to use a hybrid function having a dose-space portion and a beam-
`
`space portion, with weighting factors to determine the relative emphasis to be placed
`
`on conformity vs. efficiency. Id. at N189.
`
`VI.
`
` BACKGROUND
`
`A. Overview of the ’490 Patent
`The ’490 patent relates generally to “intensity modulated radiation therapy
`
`treatment,” and in particular to “optimization of collimator angles for multi[-]leaf
`
`collimators (“MLC”) used in intensity modulated radiation therapy treatment.” Ex.
`
`1001 at 1:26-31. The ’490 patent discloses “a new algorithm” with “a cost function,
`
`to determine an optimum collimator angle of the multi-leaf collimator.” Id. at 2:34-
`
`35. This cost function is “obtained by combining the prior algorithm based upon
`
`
`
`14
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`
`
`
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`Brahme’s orientation theory with the algorithm utilized in the present invention.” Id.
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` Petition for IPR of U.S. Patent 7,015,490
`
`at 2:8-10.
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`Use of this cost function allegedly “enhances the delivery efficiency . . . by
`
`reduc[ing] the number of segments and MUs” and/or “enhance[s] conformity of the
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`radiation beam arrangement to a target shape.” Id. at 1:58-60; 2:40-42. The delivery
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`efficiency part of the cost function “minimizes the maximum leaf travel distance”
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`that a leaf pair must move. Id. at 9:50-60. The conformity part of the cost function
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`minimizes the area difference, as explained by Brahme 1988b. The relative
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`importance of delivery efficiency and co

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