Petition for IPR of U.S. Patent 7,266,175
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`
`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.: IPR2020-00073
`U.S. Patent No. 7,266,175
`___________________
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 7,266,175
`
`

`

`
`
`Petition for IPR of U.S. Patent 7,266,175
`
`I.
`
`IV.
`
`TABLE OF CONTENTS
`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)) ........................................................................ 3
`III. CERTIFICATION (37 C.F.R. § 42.104(A)) AND PAYMENT OF FEES
`(37 C.F.R. § 42.10) ......................................................................................... 4
`IDENTIFICATION OF CLAIMS AND GROUNDS (37 C.F.R. §
`42.104(A), (B)) ................................................................................................ 4
`A. Non-Patent Literature ......................................................................... 5
`1.
`Shepard 2002 (Ex.1010) ............................................................ 6
`2.
`Que 1999 (Ex. 1012) .................................................................. 6
`3. Webb 2001 (Ex. 1006) ............................................................... 7
`4.
`Siebers 2002 (Ex. 1008) ............................................................. 7
`5.
`Bar 2001(Ex. 1014) .................................................................... 7
`TECHNOLOGY BACKGROUND .............................................................. 8
`V.
`VI. BACKGROUND ..........................................................................................11
`A. Overview of the ’175 Patent .............................................................11
`A. Relevant Prosecution History ...........................................................12
`B.
`Cited References ................................................................................17
`1.
`Shepard 2002 ...........................................................................17
`2.
`Que 1999 ...................................................................................18
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` Petition for IPR of U.S. Patent 7,266,175
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`3. Webb 2001 ...............................................................................19
`4.
`Bar 2001 ...................................................................................20
`5.
`Siebers 2002 .............................................................................21
`VII. PERSON OF ORDINARY SKILL IN THE ART (“POSITA”) .............21
`VIII. CLAIM CONSTRUCTION (37 C.F.R. § 42.104(B)(3)) ...........................22
`A.
`“total monitor units” .........................................................................22
`B.
`“segment count” ................................................................................23
`C.
`“optimizer” .........................................................................................24
`ARGUMENTS ........................................................................................................25
`IX. GROUND I: WEBB 2001 (CLAIM 1) .......................................................26
`A. Claim 1 (preamble): “A method of determining a radiation beam
`arrangement, the method comprising the steps of…” ...................26
`X. GROUND II: WEBB 2001 IN VIEW OF BAR (CLAIM 13) ..................38
`A. Claim 13. “A method of providing control of a trade-off between
`treatment plan delivery efficiency and dosimetric fitness to
`optimize a radiation treatment plan within a continuum between
`delivery efficiency and dosimetric fitness the method comprising
`the steps of… ......................................................................................38
`XI. GROUND III: WEBB 2001 IN VIEW OF BAR 2001, IN FURTHER
`VIEW OF SHEPARD (CLAIM 17) ...........................................................42
`A. Claim 17 “A method as defined in claim 13 wherein the delivery
`cost term represents a segment count; and wherein simulated
`annealing is utilized to form the radiation therapy plan having a
`delivery cost not exceeding a predetermined segment count and
`having a minimal dosimetric cost.” .................................................42
`XII. GROUND IV: WEBB 2001 IN VIEW OF BAR 2001, ALONE, OR IN
`FURTHER VIEW OF SIEBERS 2002 (CLAIM 8) .................................46
`A. Claim 8. “A method as defined in claim 1. . .” ................................46
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` Petition for IPR of U.S. Patent 7,266,175
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`XIII. GROUND V: WEBB 2001 IN VIEW OF BAR 2001, ALONE, OR IN
`FURTHER VIEW OF SIEBERS 2002, IN FURTHER VIEW OF
`SHEPARD (CLAIM 10, 19, 20) ..................................................................49
`A. Claim 10 (preamble). “A method as defined in claim 8…” ...........49
`B.
`Claim 19. “A method of providing control of a trade-off between
`treatment plan delivery efficiency and dosimetric fitness to
`optimize a radiation treatment plan within a continuum between
`delivery efficiency and dosimetric fitness, the method comprising
`the steps of…” ....................................................................................52
`C. Claim 20. “A method as defined in claim 19 wherein simulated
`annealing is utilized to form the radiation therapy plan with
`substantially optimal dosimetric cost and a delivery cost not
`exceeding a predetermined total monitor units.” ...........................54
`XIV. GROUND VI: SHEPARD 2002 IN VIEW OF QUE 1999 (CLAIMS 11,
`12) ..................................................................................................................54
`A. Claim 11. “A method of providing control of a trade-off between
`treatment plan delivery efficiency and dosimetric fitness to
`optimize a radiation treatment plan within a continuum between
`delivery efficiency and dosimetric fitness, the method comprising
`the steps of…” ....................................................................................54
`Claim 12.”A method as defined in claim 11, wherein the global
`optimization algorithm is a simulated annealing algorithm, and
`wherein the local optimization algorithm is a gradient descent
`algorithm.” .........................................................................................59
`XV. MOTIVATION TO COMBINE CITED REFERENCES .......................61
`XVI. SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS DO
`NOT NEGATE OBVIOUSNESS ...............................................................63
`XVII. CONCLUSION ............................................................................................66
`
`B.
`
`
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`
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`Petition for IPR of U.S. Patent 7,266,175
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Best Medical International, Inc. v. Elekta AB et al., Civil Action 1:19-
`cv-03409-MLB ..................................................................................................... 2
`Chore-Time Equip., Inc. v. Cumberland Corp., 713 F.2d 774 (Fed.
`Cir. 1983) ............................................................................................................ 21
`GoPro, Inc. v. Contour IP Holding LLC, 898 F.3d 1170 (Fed. Cir.
`2018) (opinion modified on other grounds) ......................................................... 5
`Okajima v. Bourdeau, 261 F.3d 1350 (Fed. Cir. 2001) ........................................... 21
`Statutes
`35 U.S.C. §§ 311-319................................................................................................. 1
`Other Authorities
`37 C.F.R. §42.8(A)(1) ................................................................................................ 2
` (37 C.F.R. § 42.8(b)(1)) ............................................................................................ 2
` (37 C.F.R. § 42.8(b)(2)) ............................................................................................ 2
` (37 C.F.R. § 42.8(b)(3)) ............................................................................................ 3
` (37 C.F.R. § 42.8(b)(3)-(4)) ...................................................................................... 3
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 3
` (37 C.F.R. § 42.10) ................................................................................................... 4
`37 C.F.R. § 42.10(b) .................................................................................................. 3
`37 C.F.R. § 42.100 et seq. .......................................................................................... 1
` (37 C.F.R. § 42.104(A)) ............................................................................................ 4
` (37 C.F.R. § 42.104(A),(B)) ..................................................................................... 4
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`

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` Petition for IPR of U.S. Patent 7,266,175
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`
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` (37 C.F.R. § 42.104(B)(3)) ..................................................................................... 22
`U.S. Patent No. 7,015,490 .............................................................................. 1, 11, 12
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`v
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`Petition for IPR of U.S. Patent 7,266,175
`
`Exhibit #
`1001
`1002
`
`1003
`1004
`1005
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
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`1013
`
`1014
`
`1015
`
`LIST OF EXHIBITS
`
`
`Description
`U.S. Patent No. 7,266,175 (“’175 patent”)
`Prosecution History of U.S. Patent Application No. 10/887,966
`which matured into U.S. Patent No. 7,266,175 (“’175 File History”)
`Declaration of Joao Seco, PhD (“Seco Declaration”)
`US Patent No. 6,393,096 (“‘096 patent”)
`US Patent No. 6,038,283 (“‘283 patent”)
`Webb, Steve. A simple method to control aspects of fluence
`modulation in IMRT planning. Physics in Medicine & Biology 46.7
`(2001): N187. PubMed P.M.I.D.: 11474945 (“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
`Siebers, Jeffrey V., et al. Incorporating multi‐leaf collimator leaf
`sequencing into iterative IMRT optimization. International Journal of
`Medical Physics Research and Practice 29.6 (2002): 952-959.
`PubMed P.M.I.D.: 12094990 (“Siebers 2002”)
`International Journal of Medical Physics Research and Practice
`Online Publication History of Siebers 2002,
`https://aapm.onlinelibrary.wiley.com/doi/abs/10.1118/1.1477230
`Shepard, D. M., et al. Direct aperture optimization: a turnkey
`solution for step‐and‐shoot IMRT. Medical physics 29.6 (2002):
`1007-1018, PubMed P.M.I.D.: 12094970 (“Shepard 2002”)
`AAPM Online Publication History of Shepard 2002,
`https://aapm.onlinelibrary.wiley.com/doi/abs/10.1118/1.1477415
`Que, William. Comparison of algorithms for multileaf collimator
`field segmentation. International Journal of Medical Physics
`Research and Practice 26.11 (1999): 2390-2396. PubMed P.M.I.D.:
`10587222 (“Que 1999”)
`AAPM Online Publication History of Que 1999,
`https://aapm.onlinelibrary.wiley.com/doi/abs/10.1118/1.598755
`Bär, W., M. Alber, and F. Nüsslin. A variable fluence step clustering
`and segmentation algorithm for step and shoot IMRT. Physics in
`Medicine & Biology 46.7 (2001): 1997. PubMed P.M.I.D.:
`11474940 (“Bar 2001”)
`IOP Publishing Ltd. publication history of Bar 2001,
`https://iopscience.iop.org/issue/0031-9155/46/7
`
`
`
`
`
`

`

`Exhibit #
`1016
`
`1017
`
`1018
`
`1019
`1020
`1021
`1022
`1023
`1024
`1025
`1026
`1027
`1028
`
`1029
`1030
`
`1031
`
`1032
`
`1033
`1034
`
` Petition for IPR of U.S. Patent 7,266,175
`
`Description
`Alber, M., and F. Nüsslin. Optimization of intensity modulated
`radiotherapy under constraints for static and dynamic MLC delivery.
`Physics in Medicine & Biology 46.12 (2001): 3229 (“Alber 2001”)
`IOP Publishing Ltd. publication history of Alber 2001,
`https://iopscience.iop.org/article/10.1088/0031-9155/46/12/311/meta
`Karzmark, Clarence J., and Robert J. Morton. Primer on theory and
`operation of linear accelerators in radiation therapy. No. FDA--82-
`8181. Bureau of Radiological Health, 1981
`Not Used
`Curriculum vitae of Arthur L. Boyer
`Arthur L. Boyer Declaration # 1 on the State of the Art in the 1990s
`Google Scholar Report for Shepard 2002 (date limited: -2003)
`Google Scholar Report for Que 1999 (date limited: -2003)
`Google Scholar Report for Webb 2001 (date limited: -2003)
`Google Scholar Report for Siebers 2002 (date limited: -2003)
`Google Scholar Report for Alber 2001 (date limited: -2003)
`Google Scholar Report for Bar 2001 (date limited: -2003)
`Carol, M. P. Where we go from here: one person’s vision. Sternick
`ES: The Theory and Practice of Intensity-Modulated Radiation
`Therapy. Madison, WI, Advanced Medical Publishing (1997): 243-
`252. (“Carol 1997”)
`Declaration of Marla Hirth
`Dai, Jianrong, and Yunping Zhu. “Minimizing the number of
`segments in a delivery sequence for intensity‐modulated radiation
`therapy with a multileaf collimator.” Medical Physics 28.10 (2001):
`2113-2120. (“Dai 2001”)
`Seco, J., Evans, P. M., & Webb, S. (2001). Analysis of the effects of
`the delivery technique on an IMRT plan: comparison for multiple
`static field, dynamic and NOMOS MIMiC collimation. Physics in
`Medicine & Biology, 46(12), 3073.
`Seco, J., Evans, P. M., & Webb, S. (2002). An optimization
`algorithm that incorporates IMRT delivery constraints. Physics in
`Medicine & Biology, 47(6), 899.
`Attachments to Ex. 1029 (Hirth Declaration) p. 1-288
`Attachments to Ex. 1029 (Hirth Declaration) p. 290-end
`
`
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`

`
`
`I.
`
`Petition for IPR of U.S. Patent 7,266,175
`
`INTRODUCTION
`Petitioner Elekta Inc. (Elekta) requests that the Board institute inter partes
`
`review (IPR) of and cancel claims 1, 8, 10-13, 17, 19, 20 (“Challenged Claims”) of
`
`U.S. Patent No. 7,266,175 (’175 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. Joao Seco (Seco
`
`Declaration) (Ex. 1003), which incorporates by reference declaration testimony of
`
`Dr. Arthur Boyer (“Boyer SOA Declaration”) (Ex. 1021), and declaration testimony
`
`of Marla Hirth (Ex. 1029). Boyer SOA Declaration. The Seco Declaration describes
`
`the ’175 patent, the POSITA in the relevant time frame, interpretation of certain
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`terms in the ’175 patent, the state of the art of the ’175 patent, the scope and content
`
`of the prior art compared to the claims of the ’175 patent, and the rationales for
`
`combining prior art elements. The Boyer SOA Declaration describes the general
`
`state of the art in radiotherapy in the 1990s.
`
`
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`

`

`
`
`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 7,266,175
`
`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 ’175 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).
`
`The ’175 patent is the subject of IPR 2020-00053 filed October 17, 2019.
`
`Case IPR 2020-00053 involves challenges to claims 13, 14, 15, 16, 18 and 19 of
`
`the ’175 patent based on Webb 2001, Mohan 2000, Webb 1993, and Siebers 2002.
`
`The Patent Owner has not yet filed preliminary responses in this proceeding. Case
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`IPR 2020-00053 does not involve claim 1, 8, 10, 11, 12, 17 and 20 of the ’175
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`patent, which are at issue in this petition. In addition, primary references presented
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`2
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`in this Petition (including Shepard 2002, Que 1999, and Bar 2001) are new and not
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` Petition for IPR of U.S. Patent 7,266,175
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`included in Case IPR 2020-00053. The arguments and evidence presented in this
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`Petition are not the same or substantially the same as those presented to the Board
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`in Case IPR 2020-00053. Moreover, this Petition is necessary to address at least
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`claims 1, 8, 10, 11, 12, 17 and 20 in view of the prior art references cited in this
`
`Petition.
`
`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 Vid R. Bhakar (Reg. No. 42,323) and Christopher
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`W. Adams (Reg. No. 62,550) as back-up counsel for this matter.
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`Postal mailings and hand-deliveries for lead and back-up counsel should be
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`addressed to: Tamara D. Fraizer, Squire Patton Boggs (US) LLP, 1801 Page Mill
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`Road, Suite 110, Palo Alto, CA 94304-1043 (Telephone: (650) 843-3201; Fax: (650)
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`843-8777).
`
`Pursuant to 37 C.F.R. § 42.8(b)(4), Petitioner consents to e-mail service at:
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`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.
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` Petition for IPR of U.S. Patent 7,266,175
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`
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`III. CERTIFICATION (37 C.F.R. § 42.104(A)) AND PAYMENT OF FEES
`(37 C.F.R. § 42.10)
`Petitioner certifies that the ’175 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
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`served with any other complaint alleging infringement of the ’175 patent.
`
`The undersigned authorizes the USPTO to charge any fees due during this
`
`proceeding to Deposit Account No. 07-1850.
`
`IV.
`
`IDENTIFICATION OF CLAIMS AND GROUNDS (37 C.F.R. §
`42.104(A), (B))
`The application for the ’175 patent was filed on July 09, 2004 by Nomos
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`Corporation, the Patent Owner’s predecessor-in-interest. This application claimed
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`priority to U.S. Provisional Application No. 60/487,067, which was filed on July
`
`11, 2003. Ex. 1003 ¶133.
`
`Because the filing date of the ’175 patent (and all applications to which it
`
`claims priority) is before the effective date of the AIA (March 16, 2013), the pre-
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`AIA statute applies.
`
`For purposes of this IPR, Petitioner treats July 11, 2003 as the effective
`
`filing date of the cited provisional applications, as the “Alleged Priority Date” for
`
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`
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`all Challenged Claims. To the extent that the Patent Owner demonstrates a date of
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` Petition for IPR of U.S. Patent 7,266,175
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`conception earlier than this, then the Petitioner shall reserve the right to adjust the
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`“Alleged Priority Date” accordingly.
`
`Petitioner relies on the following references:
`
`A. Non-Patent Literature
`
`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 (2018). 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. 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.
`
`Shepard 2002, Que 1999, Webb 2001, Siebers 2002, Bar 2001 are authentic
`
`copies of the references from their respective publications. Exs. 1010, 1012, 1005,
`
`1008, 1014; Ex. 1029 Hirth Declaration. Except for Bar 2001, each of the other
`
`references has (i) either a date stamp from the National Library of Medicine or (ii)
`
`a copyright office stamp from the Library of Congress, Copyright office, each of
`
`which signify when such institution processed the article. Id. SAP America, Inc. v.
`
`Realtime Data, LLC, IPR2016-00783, 2016 WL 667819 (PTAB Oct. 5, 2016).
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` Petition for IPR of U.S. Patent 7,266,175
`
`None of the following references below are listed on the face of the ’175
`
`patent and therefore they were never disclosed to or considered by the Examiner
`
`during prosecution.
`
`1.
`
`Shepard 2002 (Ex.1010)
`
`Shepard 2002 is a printed publication bearing a copyright date of 2002 and
`
`first published by the American Association of Physicists in Medicine (AAPM) in
`
`International Journal of Medical Physics Research and Practice, Issue: 6, Volume:
`
`29, Page: 1007-1018. Ex. 1010 1007 (“© 2002”); LG Elec., Inc. v. Advanced
`
`Micro Devices, Inc., IPR2015-00329, Paper 13 12 (PTAB Jul. 10, 2015) (copyright
`
`date is prima facie evidence of publication). Ex. 1029 ¶¶69-76. Shepard 2002 is §
`
`102(b) prior art because it was publically accessible a year before the Alleged
`
`Priority Date.
`
`2.
`
`Que 1999 (Ex. 1012)
`
`Que 1999 is a printed publication bearing a copyright date of 1999 and first
`
`published by AAPM in International Journal of Medical Physics Research and
`
`Practice, Issue: 11, Volume: 26, Page: 2390-2396. Ex. 1012 2390, (“© 1999); LG
`
`Elec., Inc. v. Advanced Micro Devices, Inc., IPR2015-00329, Paper 13 12 (PTAB
`
`Jul. 10, 2015) (copyright date is prima facie evidence of publication). See Ex. 1029
`
`¶¶77-84. Que 1999 is § 102(b) prior art because it was publically accessible a year
`
`before the Alleged Priority Date.
`
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` Petition for IPR of U.S. Patent 7,266,175
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`3. Webb 2001 (Ex. 1006)
`
`Webb 2001 is a printed publication bearing a copyright date of 2001 and
`
`first published by IOP Publishing Ltd. in the United Kingdom in “July 2001.” Ex.
`
`1006 cover page (“July 2001”), N187 (“© 2001”); LG Elec., Inc. v. Advanced
`
`Micro Devices, Inc., IPR2015-00329, Paper 13 12 (PTAB Jul. 10, 2015) (copyright
`
`date is prima facie evidence of publication). Ex. 1029 ¶¶44-60. Webb 2001 is §
`
`102(b) prior art because it was publically accessible a year before the Alleged
`
`Priority Date.
`
`4.
`
`Siebers 2002 (Ex. 1008)
`
`Siebers 2002 is a printed publication bearing a copyright date of 2002 and first
`
`published by AAPM in International Journal of Medical Physics Research and
`
`Practice, Issue: 6, Volume: 29, Page: 952-959. Ex. 1008 952, (“© 2002); LG Elec.,
`
`Inc., Paper 13 12 (copyright date is prima facie evidence of publication). Ex. 1029
`
`¶¶61-69. Siebers 2002 is § 102(b) prior art because it was publically accessible a
`
`year before the Alleged Priority Date.
`
`5.
`
`Bar 2001(Ex. 1014)
`
`Bar 2001 is a printed publication first published by IOP Publishing Ltd. in
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`Physics in Medicine & Biology, Volume 46, Number 7. Ex. 1014 952. According
`
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`7
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`

`
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`to the publisher’s website, Volume 46, Number 7 was published in July 2001.1 Ex.
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` Petition for IPR of U.S. Patent 7,266,175
`
`1029 ¶¶85-90. Bar 2001 is § 102(b) prior art because it was publically accessible a
`
`year before the Alleged Priority Date.
`
`V. TECHNOLOGY BACKGROUND
`The Challenged Claims relate to the optimization of radiotherapy treatment
`
`plans delivered by a medical linear accelerator (“LINAC”). Ex. 1021 ¶¶10-84.
`
`The major components of a radiotherapy treatment machine included a
`
`LINAC and a multi-leaf collimator (“MLC”). Id. ¶¶15-24. The MLC is affixed to
`
`the LINAC and has several sets of metallic leaves that can be moved to create an
`
`opening that shapes the beam of radiation as it exits the treatment machine. Id.
`
`¶¶28-33. Variously shaped beams can be precisely directed to a patient on a
`
`treatment couch from various directions. LINACs have been used to treat patients
`
`with radiation therapy in this manner since the early 1990s. Id. ¶29
`
`Such conformal radiation treatment requires developing a detailed treatment
`
`plan based on three-dimensional images of the patient, which is computationally
`
`intensive and mathematically challenging. Intensity Modulated Radiation Therapy
`
`(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
`
`
`1 https://iopscience.iop.org/issue/0031-9155/46/7 (Last accessed October 4, 2019).
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`patient on a scale that is smaller than the radiation beam itself (i.e., it converts a
`
` Petition for IPR of U.S. Patent 7,266,175
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`single beam into multiple sub-beams, called beamlets), usually by delivering several
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`differently shaped beams from each of several angles. Ex. 1021 ¶¶22-23; Ex. 1003
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`¶109; Figure A (shown below).
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`Beginning in the early 1990s, 3D radiation therapy treatment planning focused
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`on finding beamlet weights that give the best IMRT treatment plan. Ex. 1021 ¶53.
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`But the new IMRT plans were often not practical because they would require too
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`much time for delivery. Ex. 1003 ¶133. Long treatment times are not tolerated well
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`by patients, and not possible for busy treatment centers having many patients to be
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`treated. Id.
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`Therefore, since the mid-1990s, IMRT treatment planning has also considered
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`delivery constraints. Ex. 1003 ¶133; Ex. 1021 ¶84. “Leaf sequencing” algorithms
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`optimize the order of delivery of the MLC fields in the treatment plan (known as
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`“segments”) in view of such constraints, to reduce treatment time and make delivery
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`more efficient. Ex. 1003 ¶134. In 2001, Dai et al. introduced the concept of
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`complexity and studied its effects on IMRT planning. Ex. 1030 Abstract. They
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`measured complexity as the number of contiguous “blocks” in an intensity matrix
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` Petition for IPR of U.S. Patent 7,266,175
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`(as shown below Ex. 1003 ¶117) that have the same intensity level.
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`Dai 2001, and others, considered how treatment delivery time and other aspects of
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`the treatment plan depended on the complexity of the intensity field. Id. ¶141.
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`Sequencing algorithms were initially applied after the process of defining the
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`intensity maps for each beam. But it was known by 2002 that there was a trade-off
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`between optimizing the dose and optimizing delivery, and that optimizing dose and
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`delivery together could provide control over the relative quality and efficiency of the
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`plan. Ex. 1003 ¶¶135-139; e.g., Ex. 1006 (hybrid cost function “X.”)
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`The ’175 patent relates to this aspect of IMRT treatment planning, namely,
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`the “user control of the tradeoff, or correlation, between the factors of treatment plan
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`efficiency and dosimetric fitness to optimize a radiation therapy, or radiotherapy,
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`plan,” including by use of a hybrid cost function. Id. at1:29-32.
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`VI. BACKGROUND
`A. Overview of the ’175 Patent
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` Petition for IPR of U.S. Patent 7,266,175
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`The ’175 patent describes “controlling the tradeoff between delivery
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`efficiency and dosimetric fitness in radiation treatment plans.” Ex. 1001 2:8-20.
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`“Delivery Efficiency” is “defined and quantified in terms of ‘Segmentation
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`Count’ and ‘Total Monitor Units.’” Id. 2:23-24. “Segment Count” is the “number
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`of required segments.” Id. 2:27-28. “Beam on time is proportional to Total Monitor
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`Units required for treatment delivery.” Id. 2-34 -35. Accordingly, “total Monitor
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`Units are a quantitative measure of Delivery Efficiency.” Id. 2:20-21. “Dosimetric
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`Fitness may be quantified with reference to ‘Dosimetric Cost.’” Id. 2:23-24. In
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`IMRT, The Dosimetric cost is used to “quantif[y]” “the fitness of a dose
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`distribution, [and]. [d]ose distributions with low Dosimetric Cost are generally
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`deemed superior to those with a high Dosimetric Cost.” Id. 2:23-24. Thus,
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`“Dosimetric Cost” is inversely related to “Dosimetric Fitness.”
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`The ’175 patent states that it provides a “user control” “of the tradeoff between
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`dosimetric fitness and delivery efficiency” by first, “ providing user control of the
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`segment count in a treatment plan… wherein a delivery cost term based upon the
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`complexity of the intensity maps may be utilized… to drive[] the optimizer toward
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`a simpler, more efficient solution,” second, “providing user control in a treatment
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`plan… of total monitor units” and third, “choosing an optimization algorithm as a
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`method of controlling treatment efficiency. Specifically, gradient descent and
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` Petition for IPR of U.S. Patent 7,266,175
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`simulated annealing are compared in terms of dosimetric cost and delivery
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`efficiency.” Id. 2:23-24.
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`A. Relevant Prosecution History
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`U.S. Patent Application No. 10/887,966 (“the ‘966 application”), which
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`resulted in the ’175 patent, was filed on July 9, 2004. Ex. 1002 1.
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`In response to an Office Action dated May 3, 2006, the applicant canceled all
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`seventeen original claims and submitted new claims 18-38. Id. 178-198. Applicant
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`also amended the specification to incorporate by reference U.S. Patent Nos.
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`6,038,283 and 6,393,096. Id.
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`The Examiner issued a final Office Action dated October 25, 2006, rejecting
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`claims 18-38 as unpatentable over Pirzkall et al. in view of PCT Publication WO
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`02/49044 to Alber (“Alber”). Id. 220-232.
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`In response, the applicant amended claims 18, 20, 21, 24, 28, 29, and 35, and
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`cancelled claim 19, incorporating the subject matter of this claim into claim 18. The
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`applicant argued that the Examiner had failed to make a prima facie case of
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`obviousness (as required), and that Pirzkall et al. and Alber, alone or in combination,
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`do not teach or suggest the following elements:
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`“providing control of a trade-off between treatment plan
`(1)
`dosimetric fitness and delivery efficiency within an optimizer or within
`the optimization loop to optimize a radiation treatment plan within a
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` Petition for IPR of U.S. Patent 7,266,175
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`continuum between delivery efficiency and dosimetric fitness,” as
`recited in [issued claim 1];
`(2)
`“applying prescription parameters to each of a plurality of
`optimization algorithms within an optimizer, and selecting one of the
`plurality of algorithms through the optimizer responsive to a user
`selection between enhanced delivery efficiency and enhanced
`dosimetric fitness,” as recited in [issued claim 1];
`(3)
`“assigning a delivery cost term within an optimizer to each of a
`plurality of intensity maps representing a potential radiation beam
`arrangement, and evaluating an objective cost function for each of the
`plurality of intensity maps,” as recited in [issued claim 1]; and/or
`(4)
`“evaluating within an optimizer for each of a plurality of
`intensity maps an objective cost function including a dosimetric cost
`term and a the delivery cost term, and rejecting each intensity map
`resulting in the delivery cost term exceeding a preselected threshold
`value,” as recited in [issued claim 19].
`Id. 251-275, 373.
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`The applicant also included a declaration by Mark P. Carol, a founder of
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`Nomos Corporation, commenting on the novelty of the claims. Id. 279-359.
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`In this declaration, Mark Carol declared that the “impetus for the Romesberg
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`patent was to propose for the first time the concept of giving the user the ability to
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`control directly on a patient-by-patient basis the competing needs of conformality /
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`avoidance (dosimetric fitness) and efficiency,” by “adding a delivery cost term in
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`the cost function that quantifies plan efficiency.” Carol also declared that “[t]his term
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`may access the number of segments required to deliver a plan, thus driving a plan
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`toward the use of a smaller number of simpler segments, or it may evaluate the total
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`number of monitor units required to deliver the plan, thus driving the plan toward
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`requiring less radiation, and therefore less machine time.” Carol further declared that
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` Petit