Petition for IPR of U.S. Patent 6,038,283
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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.: IPR2020-00070
`U.S. Patent No. 6,038,283
`___________________
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 6,038,283
`
`

`

`
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`Petition for IPR of U.S. Patent 6,038,283
`
`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)) ........................................................................ 3
`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. Non-Patent Literature ......................................................................... 5
`1.
`Niemierko-RONSC ................................................................... 6
`2.
`Goitein-1992 ............................................................................... 7
`3. Mohan-1994 ............................................................................... 7
`TECHNOLOGY BACKGROUND .............................................................. 8
`V.
`VI. BACKGROUND ..........................................................................................17
`A. Overview of the ’283 patent ..............................................................17
`A. Relevant Prosecution History ...........................................................21
`B.
`Cited References ................................................................................22
`1.
`Niemierko-RONSC .................................................................22
`2.
`Goitein-1992 .............................................................................23
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` Petition for IPR of U.S. Patent 6,038,283
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`3. Mohan-1994 .............................................................................23
`VII. PERSON OF ORDINARY SKILL IN THE ART (“POSITA”) .............24
`VIII. CLAIM CONSTRUCTION (37 C.F.R. § 42.104(B)(3)) ...........................24
`ARGUMENTS ........................................................................................................25
`IX. GROUND #1: NIEMIERKO-RONSC COMPARED TO CLAIMS 1, 10,
`22, 25 .............................................................................................................26
`A. Claim 1. “A method of determining an optimized radiation beam
`arrangement for applying radiation to a tumor target volume
`while minimizing radiation of a structure volume in a patient,
`comprising the steps of…” ................................................................26
`Claim 10: “The method of claim 1…” .............................................34
`B.
`C. Claim 22: “A method of determining an optimized radiation beam
`arrangement for applying radiation to a tumor target volume
`while minimizing radiation of a structure volume in a patient,
`comprising the steps of…” ................................................................35
`D. Claim 25: “An apparatus for determining an optimized radiation
`beam arrangement for applying radiation to a tumor target
`volume while minimizing radiation of a structure volume in a
`patient, comprising…” ......................................................................37
`X. GROUND #2: NIEMIERKO RONSC IN VIEW OF GOITEIN
`COMPARED TO CLAIMS 23, 24, 26, 33, 40, 44 .....................................39
`A. Claim 23: “The method of claim 22…” ...........................................39
`B.
`Claim 24: “The method of claim 22…” ...........................................40
`C. Claim 26: “The method of claim 25…” ...........................................41
`D. Claim 33: “A method of determining an optimized radiation beam
`arrangement for applying radiation to at least one tumor target
`volume while minimizing radiation to at least one structure
`volume in a patient, comprising the steps of…” .............................42
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` Petition for IPR of U.S. Patent 6,038,283
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`E.
`
`Claim 40: “A method of determining an optimized radiation beam
`arrangement for applying radiation to at least one tumor target
`volume while minimizing radiation of at least one structure
`volume in a patient, comprising the steps of…” .............................45
`Claim 44: “The method of claim 40…” ...........................................46
`F.
`XI. GROUND #3: NIEMIERKO RONSC IN VIEW OF MOHAN 1994
`COMPARED TO 6 ......................................................................................48
`A. Claim 6: “The method of claim 1…” ...............................................48
`XII. GROUND #4: NIEMIERKO RONSC IN VIEW OF GOITEIN 1992 IN
`FURTHER VIEW OF MOHAN 1994 COMAPRED TO CLAIMS 27,
`28, 34, 42, 46 .................................................................................................49
`A. Claim 27: “The apparatus of claim 25, further comprising…”....49
`B.
`Claim 28: “The apparatus of claim 27…” ......................................51
`C. Claim 34: “The method of claim 33…” ...........................................51
`D. Claim 42: The method of claim 40... ................................................52
`E.
`Claim 46: “The method of claim 44…” ...........................................52
`XIII. MOTIVATION TO COMBINE CITED REFERENCES .......................52
`XIV. SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS DO
`NOT NEGATE OBVIOUSNESS ...............................................................54
`XV. SUMMARY CHARTS ................................................................................55
`XVI. CONCLUSION ............................................................................................68
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`Petition for IPR of U.S. Patent 6,038,283
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Best Med. Int’l, Inc. v. Accuray, Inc., No. 2:10-cv-1043, 2010 U.S.
`Dist. LEXIS 128367 (W.D. Pa. Dec. 2, 2010) ............................................... 2, 25
`Best Medical International, Inc. v. Elekta Inc. and Elekta Limited,
`Civil Action 1:19-cv-03409-MLB ........................................................................ 2
`Best Medical International, Inc. v. Varian Medical Systems, Inc. et al,
`Civil Action 1:18-cv-01599 .................................................................................. 2
`Chore-Time Equip., Inc. v. Cumberland Corp., 713 F.2d 774 (Fed.
`Cir. 1983) ............................................................................................................ 24
`GoPro, Inc. v. Contour IP Holding LLC, 898 F.3d 1170 (Fed. Cir.
`2018) ..................................................................................................................... 5
`LG Elec., Inc. v. Advanced Micro Devices, Inc., IPR2015-00329,
`Paper 13 (PTAB Jul. 10, 2015) ......................................................................... 6, 7
`Medtronic Inc. v. NuVasive Inc., IPR2014-00087, Paper 44 (PTAB
`Apr. 3, 2015) ....................................................................................................... 54
`Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333 (Fed. Cir.
`2013) ................................................................................................................... 54
`Okajima v. Bourdeau, 261 F.3d 1350 (Fed. Cir. 2001) ........................................... 24
`Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010).................................... 54
`Statutes
`35 U.S.C. 102(e) ...................................................................................................... 21
`35 U.S.C. §103 ......................................................................................................... 25
`35 U.S.C. §§ 311-319................................................................................................. 1
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` Petition for IPR of U.S. Patent 6,038,283
`
`
`
`Other Authorities
`37 C.F.R. 42.100(b) ................................................................................................. 25
`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) ................................................................................................... 3
`37 C.F.R. § 42.10(b) .................................................................................................. 3
`37 C.F.R. § 42.100 et seq. .......................................................................................... 1
` (37 C.F.R. § 42.104(A)) ............................................................................................ 3
` (37 C.F.R. § 42.104(A),(B)) ..................................................................................... 4
` (37 C.F.R. § 42.104(B)(3)) ..................................................................................... 24
`U.S. Patent No. 5,513,238 ........................................................................................ 21
`U.S. Patent No. 6,038,283 .................................................................................passim
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`Petition for IPR of U.S. Patent 6,038,283
`
`LIST OF EXHIBITS
`
`
`Description
`U.S. Patent No. 6,038,283 (“’283 patent”)
`Prosecution History of U.S. Patent Application No. 10/915,968,
`which matured into U.S. Patent No. 6,038,283
`Declaration of Joao Seco, Ph.D.
`Niemierko, Andrzej, Random search algorithm (RONSC) for
`optimization of radiation therapy with both physical and biological
`end points and constraints, International Journal of Radiation
`Oncology* Biology* Physics 23.1 (1992): 89-98, PubMed P.M.I.D.:
`1572834 (“Niemierko-RONSC”)
`Science Direct (Elsevier) Online Publication History of Niemierko-
`RONSC
`Goitein, Michael, The comparison of treatment plans. Seminars in
`radiation oncology, Vol. 2. No. 4. WB Saunders, 1992, PubMed
`P.M.I.D.: 10717041 (“Goitein-1992”)
`Science Direct (Elsevier) Online Publication History of Goitein-1992
`Mohan, Radhe, et al., The potential and limitations of the inverse
`radiotherapy technique. Radiotherapy and Oncology 32(3) (1994):
`232-248, PubMed P.M.I.D.: 7816942 (“Mohan-1994”)
`Elsvier Publication History of Mohan-1994
`Declaration of Librarian, Marla Hirth
`Boyer Declaration on the State of the Art in the 1990s (“Boyer SOA
`Declaration”)
`Curriculum vitae of Prof. Joao Seco
`Carol, M. P., Where we go from here: one person’s vision, pages
`243-252 in Sternick, ES, The Theory and Practice of Intensity-
`Modulated Radiation Therapy, Madison, WI, Advanced Medical
`Publishing (1997) (“Carol 1997”)
`Carol, Mark P., et al., 3-D planning and delivery system for
`optimized conformal therapy, International Journal of Radiation
`Oncology• Biology• Physics 24 (1992): 156 (“Carol 1992”)
`Carol, Mark P., Peacock™: A system for planning and rotational
`delivery of intensity‐modulated fields, International Journal of
`Imaging Systems and Technology 6.1 (1995): 56-61 (“Carol 1995”)
`Special Master’s Report and Recommendation in Best Med. Int’l,
`Inc. v. Accuray, Inc., No. 2:10-cv-1043, 2013 U.S. Dist. LEXIS 4452
`(W.D. Pa. Jan. 11, 2013)
`
`Exhibit #
`1001
`1002
`
`1003
`1004
`
`1005
`
`1006
`
`1007
`1008
`
`1009
`1010
`1011
`
`1012
`1013
`
`1014
`
`1015
`
`1016
`
`
`
`
`
`

`

`Exhibit #
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`1022
`1023
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`1030
`
`
`
`
`
`
` Petition for IPR of U.S. Patent 6,038,283
`
`Description
`January 11, 2013 Order from Best Med. Int’l, Inc. v. Accuray, Inc.,
`No. 2:10-cv-1043, 2013 U.S. Dist. LEXIS 4452 (W.D. Pa. Jan. 11,
`2013)
`Lawrence, Theodore, et al., “The use of 3-D dose volume analysis to
`predict radiation hepatitis,” Int. J. Radiation Oncology Bio. Phys.
`Vol. 23 (1992);781-788 (“Lawrence 1992”).
`Webb, S., “Optimisation of conformal radiotherapy dose distribution
`by simulated annealing,” Physics in Medicine & Biology 34.10
`(1989): 1349 (“Webb 1989”)
`Webb, S., “Optimization of conformal radiotherapy dose
`distributions by simulated annealing: II. Inclusion of scatter in the
`2D technique,” Physics in Medicine & Biology 36.9 (1991): 1227
`(“Webb 1991”)
`Google Scholar Report for Niemierko RONSC (date limited: -1996)
`Google Scholar Report for Goitein 1992 (date limited: -1996)
`Google Scholar Report for Mohan 1994 (date limited: -1996)
`Rosen, Isaac I., et al., Comparison of simulated annealing algorithms
`for conformal therapy treatment planning, International Journal of
`Radiation Oncology• Biology• Physics 33.5 (1995): 1091-1099
`(“Rosen 1995”)
`Webb, S., and M. Oldham. A method to study the characteristics of
`3D dose distributions created by superposition of many intensity-
`modulated beams delivered via a slit aperture with multiple
`absorbing vanes. Physics in Medicine & Biology 41.10 (1996):
`2135. (“Webb and Oldham 1996”)
`Webb, S. “Optimizing Radiation Therapy Inverse Treatment
`Planning Using the Simulated Annealing Technique,” Int’l J.
`Imaging Syst. Tech. Vol. 6:71-79 (1995) (“Webb 1995”)
`Withers, H. Rodney, et al., Treatment Volume and Tissue Tolerance.
`Int. J. Radiation Oncology Biol. Phys., Vol. 14:751-759 (1988)
`(“Withers 1988”)
`Niemierko, Andrzej, et al., Optimization of 3D Radiation Therapy
`with Both Physical and Biological End Points and Constraint, Int. J.
`Radiation Oncology, Biol., Phys., Vol. 23 (1992): 99-108
`(“Niemierko 1992a”)
`Attachments to Ex. 1010 (Hirth Declaration) p. 1-288
`Attachments to Ex. 1010 (Hirth Declaration) p. 289-end
`
`
`vii
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`

`
`
`I.
`
`Petition for IPR of U.S. Patent 6,038,283
`
`INTRODUCTION
`Elekta Inc. (“Elekta” or “Petitioner”) requests that the Board institute inter
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`partes review (“IPR”) of and cancel claims 1, 6, 10, 22, 23, 24, 25, 26, 27, 28, 33,
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`34, 40, 42, 44 and 46 (“Challenged Claims”) of U.S. Patent No. 6,038,283 (“the ’283
`
`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 Professor Joao Seco
`
`(“Seco Declaration”) (Ex. 1003), which incorporates by reference declaration
`
`testimony of Dr. Arthur Boyer (“Boyer Declaration”) (Ex. 1011), and declaration
`
`testimony of Marla Hirth (“Hirth Declaration”) (Ex. 1010). The Seco Declaration
`
`describes the ’283 patent, the person of ordinary skill in the art in the relevant time
`
`frame, interpretation of certain terms in the ’283 patent, the state of the art of the
`
`’283 patent, the scope and content of the prior art compared to the claims of the ’283
`
`patent, and the rationales for combining prior art elements. The Boyer Declaration
`
`describes the general state of the art in radiotherapy in the 1990s. The Hirth
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`Declaration describes the authenticity and public availability of the cited references.
`
`
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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 6,038,283
`
`Petitioner identifies Elekta Limited (UK), Elekta Holdings U.S., Inc. and
`
`Elekta AB as real parties of interest without admitting that they are in fact real parties
`
`of 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 ’283 patent in Best Medical International, Inc. v.
`
`Elekta Inc. and Elekta Limited, Civil Action No. 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 No. 1:18-cv-
`
`01599 (currently pending in the District of Delaware).
`
`Patent Owner previously asserted the ’283 patent in Best Med. Int’l, Inc. v.
`
`Accuray, Inc., No. 2:10-cv-1043, 2010 U.S. Dist. LEXIS 128367 (W.D. Pa. Dec. 2,
`
`2010).
`
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` Petition for IPR of U.S. Patent 6,038,283
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`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 also designates Christopher W. Adams (Reg. No. 62,550), Vid
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`R. Bhakar (Reg. No. 42,323), and William Gvoth (Reg. No. 74,308) as back-up
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`counsel for this matter.
`
`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)
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`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 ’283 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.
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`

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` Petition for IPR of U.S. Patent 6,038,283
`
`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 ’283 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 ’283 patent was filed on October 24, 1997 (U.S. Serial
`
`No. 08/957,206) by Nomos Corporation, the Patent Owner’s predecessor-in-interest.
`
`This application claimed priority to U.S. Provisional Application No. 60/029,480,
`
`which was filed on October 24, 1996. Ex. 1001 at cover page; Ex. 1002.
`
`Because the filing date of the ’283 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 October 24, 1996 as 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, then the Petitioner shall reserve the right to adjust the
`
`“Alleged Priority Date” accordingly.
`
`Petitioner relies on the following references:
`
`
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`4
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`
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`A. Non-Patent Literature
`
` Petition for IPR of U.S. Patent 6,038,283
`
`The non-patent prior art references on which Petitioner relies are identified
`
`below. Each of these references qualifies as a printed publication under § 102(b).
`
`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.
`
`Niemierko-RONSC (Ex. 1004), Goitein 1992 (Ex. 1006), and Mohan 1994
`
`(Ex. 1008) are authentic copies of the references from their respective publications
`
`bearing either (i) 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. Ex. 1010 at ¶¶17-37 and
`
`91-110; see SAP America, Inc. v. Realtime Data, LLC, IPR2016-00783, 2016 WL
`
`667819 (PTAB Oct. 5, 2016) (noting sufficient indicia of public availability included
`
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`copyright date, ISBN number, and Library of Congress Cataloging-in-Publication
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` Petition for IPR of U.S. Patent 6,038,283
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`Data).
`
`None of the following references are listed on the face of the ’283 patent and
`
`therefore they were not considered by the Examiner during prosecution.
`
`1.
`
`Niemierko-RONSC
`
`Niemierko-RONSC is a printed publication bearing a copyright date of 1992
`
`and first published by the American Society for Therapeutic Radiation and Oncology
`
`(ASTRO) in the International Journal of Radiation Oncology*Biology*Physics,
`
`Volume 23, Issue 1, 1992, pages 89-98. See Ex. 1004 at 89; 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).
`
`Niemierko-RONSC includes other indicia of its public accessibility, including
`
`National Library of Medicine publication data (Ex. 1004 at 1) and publisher
`
`information (Ex. 1005).
`
`Niemierko-RONSC was cited by other references prior to the Alleged Priority
`
`Date, including (i) Mohan-1994 (Ex. 1008) and (ii) Rosen 1995 (Ex. 1024). Ex. 1010
`
`at ¶98; 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).
`
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` Petition for IPR of U.S. Patent 6,038,283
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`Thus, Niemierko-RONSC is § 102(b) prior art, publicly accessible at least a
`
`year before the Alleged Priority Date.
`
`Goitein-1992
`
`2.
`Goitein-1992 is a printed publication bearing a copyright date of 1992 and
`
`first published by W.B. Saunders Company, in Seminars in Radiation Oncology,
`
`Volume 2, Issue 4, October 1992, pages 246-256. Ex. 1006 at 246; LG Elec., Inc.,
`
`IPR2015-00329, Paper 13 at 12 (PTAB Jul. 10, 2015) (copyright date is prima facie
`
`evidence of publication).
`
`Goitein-1992 includes other indicia of its public accessibility, including
`
`National Library of Medicine publication data (Ex. 1006 at 1) and publisher
`
`information (Ex. 1007).
`
`Goitein-1992 was cited by other references prior to the Alleged Priority Date.
`
`Ex. 1010 at ¶104; Spitzer at *3 (N.D. Cal. Jun. 15, 2016) (taking judicial notice of
`
`the publicly availability of a document located on Google Scholar).
`
`Goitein-1992 is § 102(b) prior art, publicly accessible at least a year before
`
`the Alleged Priority Date.
`
`3. Mohan-1994
`
`Mohan-1994 is a printed publication bearing a copyright date of 1994 and first
`
`published by Elsevier Science Ireland Ltd. in Radiotherapy & Oncology Volume 32,
`
`Issue 3, September 1994, pages 232-248. Ex. 1008 at 232; LG Elec., Inc., IPR2015-
`
`
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`7
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`

`
`
`00329, Paper 13 at 12 (PTAB Jul. 10, 2015) (copyright date is prima facie evidence
`
` Petition for IPR of U.S. Patent 6,038,283
`
`of publication).
`
`Mohan-1994 includes other indicia of its public accessibility, including
`
`National Library of Medicine publication data (Ex. 1006 at 1-2) and publisher
`
`information (Ex. 1009).
`
`Mohan-1994 was cited by other references prior to the Alleged Priority Date.
`
`Ex. 1010 at 110; see also Spitzer at *3 (N.D. Cal. Jun. 15, 2016) (taking judicial
`
`notice of the publicly availability of a document located on Google Scholar).
`
`Thus, Mohan-1994 was publicly accessible a year before the Alleged Priority
`
`Date, and is § 102(b) prior art.
`
`V. TECHNOLOGY BACKGROUND
`The ’283 patent states that it pertains to “a method and apparatus for
`
`conformal radiation therapy of tumors with a radiation beam having a pre-
`
`determined, constant beam intensity.” Ex. 1001 at 1:10-12; Ex. 1003 at ¶¶133-152;
`
`102-105.
`
`Conventional medical linear accelerators (LINACs) have been used since the
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`1970s to treat tumors with an intense beam of radiation. Ex. 1011 at ¶¶15-24. The
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`goal of “radiation therapy” is, and always has been, to target the tumor and avoid
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`damage to healthy tissues. Id. at ¶¶10-14; Ex. 1003 at ¶102. The problem is that
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`critical organs may be near the tumor, and therapeutic radiation must pass through
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`normal, healthy tissues to reach the tumor. Ex. 1011 at ¶¶10-14; Ex. 1003 at ¶102.
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`Radiation can damage or kill cells, depending on the amount of exposure. Id. So,
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`treatment planners strive to define a treatment regime that will deliver a lethal dose
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`of radiation to the tumor and tolerable doses to the critical organs and healthy tissues.
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`Id.
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`One way to do this is by using a radiation beam shaped to match the outline
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`of the tumor. Ex. 1011 at ¶¶28-33, Fig. A, I.. This is the principle of conformal
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`radiation therapy. Id. at 31. Historically, the outline of the radiation beam was
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`shaped to conform to the outline of the tumor with blocks or specially built forms.
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`Id. at ¶28, Fig. G. To further help avoid damaging healthy tissues, the radiation is
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`delivered in treatment “fractions” over days or weeks, giving healthy cells time to
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`recover. Id. at ¶12. An additional way to ensure the radiation to healthy tissues is
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`tolerable is to deliver the radiation from different directions, with a portion of the
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`dose given from each direction. Id. at ¶13. The dose concentration is highest where
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`the beams intersect (“the isocenter”), which should be at the tumor. Id. at ¶¶16-17,
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`Figs. A, B.
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`By the early 1990s, multileaf collimators (MLCs) were used with LINACs.
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`Ex. 1011 at ¶¶34-35, Fig. H. They could accurately shape (or collimate) the radiation
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`beam using narrow leaves of tungsten, that were easily positioned under control of
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`a computer. Id. at ¶¶22, 29, 31. The radiation source with the MLC could be moved
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`in an arc around the patient, so radiation could be delivered from different directions.
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`Id. at ¶¶16, 18, 19, Fig. B.
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`Also by the early 1990s, more advanced patient imaging techniques and 3D
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`computational models were available to help identify a better combination of
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`directions and beam shapes for radiation therapy. Id. at ¶25, Fig. F; Ex. 1003 at ¶103.
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`Radiation therapy using these capabilities became known as three dimensional
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`conformal radiation therapy (3DCRT). Id. at ¶34.
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`Such 3DCRT treatment plans were more complicated than previous
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`approaches, so cumulative dose-volume histograms (CDVHs) were commonly
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`used to guide evaluations of proposed 3DCRT plans. Ex. 1011 at ¶¶42-49, Fig. J;
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`Ex. 1003 at ¶119. The concept of the CDVH goes back to the 1980s. Ex. 1011 at
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`¶¶27, 40; Ex. 1003 at ¶119. A CDVH is a graph that provides information about the
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`distribution of the dose delivered to each “structure” (the tumor, each critical organ).
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`Id. at ¶42. The CDVH shows how much of a structure receives a dose equal to or
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`greater than a specified dose. Id. The CDVH gives no spatial information about the
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`delivered dose, meaning it does not provide information about where in the structure
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`the dose is delivered. Id. (Spatial information would be shown, for example, in
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`images with isodose lines. Id. at ¶¶41-42.).
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`The use of the MLC, advanced imaging techniques, computational 3D
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`modeling in radiation therapy, and dose-volume data enabled a special type of
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`3DCRT, namely, intensity-modulated radiation therapy (IMRT). Id. at ¶¶34, 59
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`Ex. 1003 at ¶¶103-105.
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`In IMRT, the amount of radiation delivered by a beam can vary on a scale less
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`than the width of the beam. Id. at ¶60. The intensity of the beam is modulated by
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`applying radiation from one direction through multiple differently shaped MLC
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`openings. Id. at ¶62, 63, Fig. L. The necessary shapes are determined by
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`mathematically decomposing the radiation beam into many small “beamlets,” each
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`of which can have a different “intensity” depending on the period of time the
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`radiation is allowed to pass through the MLC for that gantry angle position. Id. at
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`¶61, Fig. K. “Beam weights” specify the intensity of the beamlets in the beam, and
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`are referred to collectively as an “intensity map.” Id. at ¶¶61, 65; Ex. 1003 ¶110.
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`The development of IMRT required a fundamental change in the process of
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`treatment planning. In conventional forward treatment planning, values for
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`treatment delivery parameters are selected by the planner and the resulting dose
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`distribution is then determined and examined. Id. at ¶¶56, 68; Ex. 1003 at ¶102.
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`Treatment parameters are adjusted to improve the plan until the prescription goal,
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`e.g., the desired CDVH or dose constraint, is deemed to be sufficiently met. Ex. 1011
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`at ¶¶56, 68; Ex. 1003 at ¶¶108-109, 122-123. This approach was not practical for
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`complicated IMRT plans. Id. at ¶69.
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`This led to inverse planning, in which the planner starts by specifying a
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`desired dose distribution, defining a few parameters such as the beam direction, and
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`then working backwards (in “inverse”) to find the collimator settings that produce
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`the desired dose distribution. Id. at ¶¶69, 70; Ex. 1003 at ¶¶103-104. The
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`computations are difficult even for a computer, because there may be hundreds of
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`beam weights determined for each beam. Id. at ¶67. Thus, IMRT planning is not
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`possible without computers. Id. at ¶¶67, 84.
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`Moreover, it is usually not possible to mathematically (analytically) determine
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`a single best 3DCRT treatment plan. Id. at ¶¶58, 84. It certainly was not feasible
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`given the computational capabilities of computers in the early 1990s and it is not
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`possible for IMRT plans. Id. Therefore, as early as 1989, iterative optimization
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`methods were used in 3DCRT radiation therapy treatment planning, and even to this
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`day, iterative optimization methods are required for IMRT radiation therapy
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`treatment planning. Id.; Ex. 1001 at ¶105.
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`Iterative optimization is used in IMRT to find the “best” plan, where “best”
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`depends on the specified goal. Ex. 1011 at ¶72; Ex. 1003 at ¶¶110-118. An
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`“objective” or “cost” function is a mathematical description of that goal. Id. The
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`iterative process entails evaluating a sequence of possible solutions to try and find
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`the best one, without having to look at all the possibilities. Ex. 1011 at ¶71; Ex. 1003
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`at ¶¶110-112. In radiation treatment planning, each potential solution is defined by
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`the values of chosen variables such as the beam weights. Ex. 1011 at ¶¶65-57; Ex.
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`1003 at ¶110. Each potential solution has an associated value of the cost function,
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`calculated according to the values of the variables that define the potential solution.
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`Id. at ¶72.
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`The cost function characterizes the possible solutions, and provides a
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`“landscape” of all cost function values (elevations) that can be searched to find the
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`solution (location) having the best (e.g. minimum) value of the cost function. Id. at
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`¶¶72, 79. The landscape may have a single minimum, which means there is one best
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`and easy-to-find solution. Ex. 1011 at ¶80; Ex. 1003 at ¶113. Most problems are
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`more complex, with multi