UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
`
`CERTAIN COLOR INTRAORAL SCANNERS
`AND RELATED HARDWARE AND SOFTWARE
`
`INV. NO. 337-TA-1091
`
`INITIAL DETERMINATION ON VIOLATION OF SECTION 337 AND
`RECOMMENDED DETERMINATION ON REMEDY AND BOND
`· Administrative Law Judge Clark S. Cheney
`(March 1, 2019)
`
`Appearances:
`
`
`
`For the Complainant Align Technology. Inc.:
`
`
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`Blair M. Jacobs, Esq., Christina A. Ondrick, Esq,, John S. Holley, Esq., and Mark Consilvio,
`Esq. of Paul Hastings LLP of Washington, DC.
`Thomas A. Counts, Esq. of Paul Hastings LLP of San Francisco, CA.
`Raymond W. Stockstill, Esq. of Paul Hastings LLP of Costa Mesa, CA.
`Joshua M. Bennett, Esq. of Paul Hastings LLP of New York, NY.
`
`
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`For the Respondents 3Shape A/S, 3Shape Trios AIS. and 3Shape Inc.:
`
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`
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`Ooutam Patnaik, Esq., Tuhin Oanguly, Esq., David J. Shaw, Esq. of Pepper Hamilton LLP of
`Washington, DC.
`William D. Belanger, Esq., Gregory D. Len, Esq., Frank D. Liu, Esq., Brittanee L. Friedman,
`Esq., L. Andrew Tseng, Esq. of Pepper Hamilton LLP of Boston, MA.
`Charles F. Koch, Esq. of Pepper Hamilton LLP of Redwood City, CA.
`S. Lloyd Smith, Esq., Kimberly_E. Coghill, Esq., Kyle Tsui, Esq. of Buchanan Ingersoll &
`Rooney PC of Alexandria, VA.
`Philip L. Hirschhorn, Esq. of Buchanan Ingersoll & Rooney PC of New York, NY.
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`3SHAPE 1040 3Shape v Align IPR2021-01383
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`B.
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`C.
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`D.
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`E.
`III.
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`B.
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`2. 3.
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`Table of Contents
`Introduction ......................................................................................................................... 7
`Procedural History ............................................................................................ : .............. 7
`The Parties ........... _. ........................................................................................................... 9
`Complainant Align Technology, Inc . ........................................................................... 9
`The 3Shape Respondents .............................................................................................. 9
`The Asserted Patents ................................................................. ; .................................... 10
`The Color Scanner Patents ......................................................................................... 10
`The Oingival Deformation Patents ............................. .-............................................... 12
`The Technology at Issue ...................................... ; ......................................................... 14
`TI1e Accused Products .................................................................................................... 14
`E. F.
`The Domestic Industry Products ............................................ , ........................................ 15
`Jurisdiction & Importation.; ....................................................... : ...................................... 15
`u.
`A.
`Subject Matter Jurisdiction ............................................................................................ 15
`Personal Jurisdiction ...................................................................................................... 16
`B.
`In Rem Jurisdiction ........................................................................................................ 16
`C.
`Importation ..................................................................................................................... 17
`D.
`Standing ......................................................................................................................... 1·7
`Legal Principles ................................................................................................................. 17
`Claim Construction ........................................................................................................ 17
`Infringement ................................................................................................................... 19
`Literal Infringement .................................................................................................... 19
`Doctrine of Equivalents ........................................................................................... -... 20
`Indirect Infringement .................................................................................................. 20
`Validity .......................................................................................................................... 22
`Anticipation ................................................................................................................ 22
`Obviousness ................................................................................................................ 22
`Written Description and Enablement ......................................................................... 24
`Indefiniteness .............................................................................................................. 25
`Domestic Industry .......................................................................................................... 25
`D.
`Economic Prong ......................................................................................................... 26
`l.
`Technical Prong .......................................................................................................... 26
`2.
`The Color Scanner Patents ................................................................................................ 27
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`C.
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`l.
`2.
`3.
`4.
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`IV.
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`A.
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`B.
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`1.
`2.
`3.
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`4.
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`C.
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`5.
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`6.
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`1.
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`2.
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`3.
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`4.
`D.
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`Level of Ordinary Skill in the Art .................................................................................. 27
`Claim Construction Disputes ......................................................................................... 28
`Scanning System ......................................................................................................... 28
`Imaging System .......................... :" ............................................................................... 38
`Processor ..................................................................................................................... 40
`Confocal Imaging 1�echniques .................................................................................... 41
`Image Gathering .Member ... ,. ....................................................................................... 47
`Selectively Map .......................................................................................................... 47
`Infringement. .................................................................................................................. 50
`'228 Patent .................................................................................................................. 50
`'456 Patent. ................................................................................................................. 61
`'207 Patent ........................................................................... : ...................................... 64
`'433 Patent ................................................................................................................... 66
`Indirect Infringement ..................................................................................................... 70
`I. Contributory Infringement .......................................................................................... 70
`Induced Infringement ................................................................................................. 73
`Domestic Industry - Technica\ Prong ........................................................ : ................... 77
`'228 Patent .................................................................................................................. 77
`'456 Patent ................................................................................................................... 82
`'207 Patent .................................................................................................................. 82
`'443 Patent ..................... ._. ............................................................................................ 83
`Validity .......................................................................................................................... 86
`'228 Patent .................................................................................................................. 86
`'456 Patent ................................................................................................................ 104
`'207 Patent ................................................................................................................ 105
`'433 Patent ........ · ........................................................................................................ 110
`Secondary Considerations Bearing on Obviousness ................................................ 113
`3Shape's Equitable Defenses .......................................................................................... 116
`V.
`Equitable Estoppel, Waiver, and Acquiescence .......................................................... 117
`A.
`License ......................................................................................................................... 130
`a:
`C. Unclean Hands ........................................... ,_ ............... :'. .................................... _ ............ 134
`Patent Misuse ............................................................................................................... 135
`D.
`VI. Domestic Industry- Economic Prong ............................................................................ 137 ,
`Findings from Align's Earlier Investigation ................................................................ 138
`A.
`3
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`E.
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`F.
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`2.
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`1.
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`2.
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`3.
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`4.
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`1.
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`2.
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`3.
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`4.
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`5.
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`3SHAPE 1040 3Shape v Align IPR2021-01383
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`B.
`The "AU Expenditures" Theory .......... : ........................................................................ 140
`C.
`Investments Related to the Color Scanner Patents ...................................................... 142
`VU. Conclusions of Law ........................................................................................................ 146
`VIII. Recommended Determination on Remedy & Bond ....................................................... 148
`Findings of Fact Relevant to Remedy and Bond ......................................................... 148
`A.
`B.
`Limited Exclusion Order .............................................................................................. 149
`Cease and Desist Order ................................................................................................ 150
`C.
`D.
`Bond During Presidential Review .......................................... _. .................................... 153
`IX.'
`Initial Determination ....................................................................................................... 155
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`TABLE OF ABBREVIATIONS
`
`CDX Complainant's demo�trative exhibit
`cm Complainant's initial post-hearing brief
`CPD Complainant's pre-hearing brief
`Complainant's physical exhibit
`CPX
`CRB Complainant's reply post-hearing brief
`ex Complainant's exhibit_
`Deposition
`Dep.
`JX Joint Exhibit
`RDX Respondent's demonstrative exhibit
`RIB
`Respondent's initial post-hearing brief
`RPX
`Respondent's physical exhibit
`RPB Respondent's Pre-hearing brief
`Respondent's reply post-hearing brief
`RRB
`Respondent's rebuttal exhibit
`RRX
`RX
`Respondent's exhibit
`SIB Staffs initial post-hearing brief
`--
`Staffs Pre-hearing brief
`SPB
`Staffs reply post-hearing brief
`SRB
`Transcript
`'fr.
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`\
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`------------· .... -··---- .. ---..... ------- - ---···--····- . -----------. ·-----------··•·····--------�------ ------------------------------- -----------
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`3SHAPE 1040 3Shape v Align IPR2021-01383
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`J
`
`In the Matter of
`
`CERTAIN COLOR INTRAORAL SCANNERS
`AND RELATED HARDWARE AND SOFTWARE
`
`INV. NO. 337-TA-1091
`
`INITIAL DETERMINATION ON VIOLATION OF SECTION 337 AND
`RECOMMENDED DETERMINATION ON REMEDY AND BOND
`Administrative Law Judge Clark S. Cheney
`(March l, 2019)
`Pursuant to the Notice of Investigation, 82 Fed. Reg. 60418 (Dec. 20, 2017), this is the
`final Initial Determination in the matter of Certain Color lntraora/ Scanners and Related
`19 C.F.R. §§ 210. l0(b),
`Hardware and Software, Investigation No. 337-TA-1091.
`210.42(a)(l )(i).
`For the reasons stated herein, I have determined that no violation of section 337 of the
`Tariff Act of 1930, as amended, has occurred in the importation into the United States, the sale for
`importation, or the sale within the United States after importation of certain color intraoral scanners
`and related hardware and software alleged to infringe U.S. Patent No. 8,363,228 ("the '228
`patent"); U.S. Patent No. 8,451,456 ("the '456 patent"); U.S. Patent No. 8,675,207 ("the '207
`patent"); U.S. Patent No. 9,101,433 ("the '433 patent"). I have further determined that the
`investigation should be terminated with respect to articles alleged to infringe U.S.< Patent No.
`6,948,93 I ("the '931 patent"); and U;S. Patent No. 6,685,470 ("the '470 patent"), without a
`finding of violation:
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`I.
`
`INTRODUCTION
`A.
`Procedural History
`On Nov ember 14, 201 7 , complainant Align Technol ogy, I nc. of San Jose, California
`("Align") fi led a complaint alleging violati ons of sect ion 337 bas ed upon the importation into the
`U nited Sta tes, the sale for i mportation, and the sale within the United States after i mpor tation of
`certain color int raoral s canners and related hardware a nd s oftware by reason of infringement of
`one or m ore of U.S. Patent No. 8 ,363,228 (" the '228 patent"); U.S. Patent No. 8 ,451,456 (" the
`'456 patent"); U.S. Patent No. 8 ,675,207 ( "the '207 patent"); U.S. Patent No. 9 ,101,433 ("the
`'433 patent"); U.S. Patent No. 6,948,931 (" the '9�1 patent"); a nd U.S. Patent No. 6,685,470
`("the '470 patent"). 82 F ed. Reg. 60418 (Dec. 20, 2017).
`On D ecember 20, 201 7 , the Commission ins ti tuted this i nvesti gation to determine:
`whet her t here is a violation of s ubsection (a)(l )(B) of s ection 337 i n the i mportation
`into the United States, the sale for importation, or the sale within t he United S tates
`after importation of certai n col or intraoral s ca nners a nd related hardware and
`s oftware by reason of infringem�nt of one or more of claims 1, 2, 4 , 5, 7, 18, 20,
`21 , and 26 of the '228 patent; claims 1-8 and 15-18 of the '456 patent; claims 1, 2,
`4 , a nd 15-21 of the '207 patent; claims I , 4 , 7 , 10, 12, a nd 14 of the '433 patent;
`a nd claims 1-12 of the '931 patent; and claims l-12 of the '470 patent, and whether
`an industry in the Uni ted States exists as required by s ubsection (a){2) of s ection
`337.
`
`Id.
`
`The named respondents were 3Shape A/S of C openhagen, Denmark; and 3Shape Inc. of
`Warren, New J ersey. See id at 60419. On March 15, 2018 , I granted Align's u noppos ed motion
`to amend the complai nt and notice of investi gation to, add 3Shape Tri os A/S of Copenhagen,
`D enmark as an addit ional respondent in this i nvestigation. Order No. 1 1; see also Notice of a
`Commission Determination not to Review an Initial D etermination Granting a Motion for L ea ve
`to Amend the Com plai nt and Notice of Investigation to A dd Respondent (Mar. 26, 2018) (EDIS
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`Doc. ID 640017). Throughout the investigation, all parties have referred to the three 3Shape
`entities collectively as "3Shape," and I follow that convention in this determination.
`The Commission investigative staff is not a party to this investigation.
`On, May 18, 2018, I denied 3Shape's motion for swnmary determination and termination
`of the investigation based on a forum selection clause in a Scanner Agreement between Align and
`3Shape Trios NS. Order No. 23. On J uly 10, 2018, I granted Ali gn's unopposed motion for
`termination of the investigation with respect to claim 7 of the '456 patent; claims 1-4, 7, and 10 of
`the '433 patent; claims 4-12 of the '470 patent; and claims 4-12 of the '931 patent. ,Order No. 27;
`see also Notice of a Comm'n Det. not to Review an Initial Det. Granting a Mot. for Partial Term.
`of the Inv. Based on Withdrawal of Certain Claims (Aug. 7, 201 8) (EDIS Doc. ID 652179). On
`July 1 1, 2018, I denied 3Shape' s motion for summary detennination of no violation with respect
`to the entity 3Shape Inc. Order No. 28. On September 6, 2018, I denied 3Shape's motion to
`terminate the investigation with respect to the '4 70 and '931 patents on the basis that those patents
`would expire six days before the May 20, 2019, target date then in effect for this investigation.
`Order No. 34.
`r convened an evidentiary hearing on September 1 7-21, 2018, to determine whether section
`· 3 3 7 has been violated by reason of the i mportation into the United States, the sale for importation,
`or the sale within the United States after importation of allegedly infringing color intraoral
`scanners and related hardware and software. Following the close of the evidentiary hearing. a
`lapse in government appropriations from December 22, 201 8, through January 25, 2019, caused
`the Commission to temporarily cease regular operations, whi ch precluded completion of this initial
`determination. On January 29, 2019, I issued an initial determination extending the target date in
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`this in vestigation to July 1, 2019, which correspondingly ex tended the deadline fo r c ertifying the
`record and a fmal initial determin ation on violati on to March l, 2019. Order No. 39.
`B.
`The Parties
`1.
`Complainant Align Technoiogy, Inc.
`Align is a publicly- traded corporation organized and existing under the laws of the State o{
`D elaware, with its principal p] ace of business located at 2820 Orc hard Parkway, San Jose,
`California 95134. 2d Am. Comp!. at ,r 13. Align is the owner by assignment of the asserte d patents
`in thi s investi gation. See JX-0001 at Cover; JX-0002 at Cover; JX-0039 (assignment record); JX-
`0040 (assignment record); JX-0041 (assignment record).
`
`The 3Shape Respondents
`2.
`3Shape A/S, 3Shape Trios A/S, and 3Shape Inc. are "sister'' c orpora tions that are wholly­
`owned subsidiaries of 3Sh ape Holdings A/S. See RPB at 13.
`
`3SJ,ape Trios AIS
`a)
`3Shap e Trios A/S is a Danish corporation with its principal place of business at Holmens
`KanaJ 7, 1060 Cope nhagen K, Denm ark. 3Shape T rios A/S develops and sells the accused Trio s
`scanners, inc luding the Trios application software and ScanSuite Trios software included on those
`scanners. See RPB at 13.
`
`3SJ,ape AIS
`b)
`3Shape A/S is a Danish corporation with its principal place of business at H olmens KanaJ
`7, 1060 Copenhagen K, D enmark. 3Shape represents that 3Shape A/S develops and sells certain
`''lab scanner" products not accused in this investigation. 3Shape A/S also develops, sells, and
`l icenses 3Shape's accused Dental System and O rtho System software. See RPB at 13.
`
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`3SHAPE 1040 3Shape v Align IPR2021-01383
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`JS/tape /11c.
`c)
`is a Delaware corporation with a principal pl ace of business at 10
`3S hape Inc.
`Inde pendence Boule vard, Suite 150, Warren, New Jersey 07059. 3S hape represents th at "3Shape
`I nc. is 3S hape's regional support entity fo r North America. It supports 3Shape's U.S. distributors,
`or • resell ers' by providing marketing and afte r-sal es support and trai ning, includi ng administeri ng
`3S hape's warranty , repair, and repl acement p rogram." RPB at 13.
`The Asserted Patents
`C.
`Ali gn asserts two categories of patents in this investigation: ( 1) the color scanner patents
`and (2) the gingi val deformation patents.
`
`l.
`The Color Scanner Patents
`The parties refer to the '228, '456, '207, and '433 p at en ts coJlecti vely as "the col or scanne r
`patents."
`United S tates Patent Number 8,363,228, entitl ed "Me thod and Apparatus for Col our
`I maging a Thre e-Dim ensional S tructure," issued to Noam B abyoff on January 29, 2013. JX-0003
`at cover page. The patent issued from A ppli cati on Number 13/333,351, filed on December 21,
`20 I 1, and cl aims priority to provisi on application No. 60/580, 109, file d on June 17, 2004, and
`provisional appl ication No. 60/580,108 fi led on June 17, 2004. id The patent, on its face, is
`assi gned to Cadent Ltd. Id. Align acquired ownership of the patent through assi gnment. See
`JX-0039.
`Unite d S tates Patent Numbe r 8,451,456 entitled "Me th od and Apparatus for C olour
`Imaging a Three-Dimensional S tructure," issued to Noam Babyoff on M ay 28, 2013. JX-0004 at
`· cover page: The patent issued from Application Number 13/620, 159, filed on S e pte mber 1 4, 2012,
`and claims priori ty to provisional appli cation No. 60/580,109, fi le d on June 17, 2004, and
`
`to
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`3SHAPE 1040 3Shape v Align IPR2021-01383
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`provisional application No. 60/580, 108 filed on June 17, 2004. Id. The patent, on its face, is
`assigned to Cadent Ltd. Id Align acquired ownership of the patent through assignment. See
`JX-0039.
`United States Patent Number 8,675,207 entitled "Method and Apparatus for Colour
`Imaging a Three-Dimensional Stmcture," issued to Noam Babyoff on March 18, 2014. JX-0005
`at cover page. The patent issued fr<?m Application Number 13/868,926, filed on April 23, 2013,
`and claims priority to provisional application No. 60/580,109, filed on June l7, 2004, and
`provisional application No. 60/580,108 filed on June 17, 2004. Id The patent, on its face, is
`assigned to Cadent Ltd. Id. Align acquired ownership of the patent through assignment. See
`JX-0039.
`United States Patent Number 9,101,433 entitled "Method and Apparatus for Colour
`Imaging a Three-DimensionaJ Structure," issued to Noam Babyoff on August 1 1, 2015. JX-0006
`at cover page. The patent issued from Application Number 14/511,091, filed on October 9, 2014,
`and claims priority to provisional application No. 60/580,109, filed on June 17, 2004, and
`provisional application No. 60/580, 108 filed on June 17, 2004. Id at cover page-p. 2. The patent,
`on its face, is assigned to Align Technology, Inc. Id. at cover page
`The color scanner patents are all directed to systems or methods for creating a color image
`of a three dimensional structure, particularly by combining color and depth data to provide a thre�­
`dimensional color model. See, e.g. , JX-0003 at Abstract. The color scanner patents share
`substantially identical specifications and claim priority to the same parent application. Compare
`JX-0003 with JX-0004, JX-0005, and JX-0006. There is also substantial overlap in the asserted
`claims of the '228 patent, the '456 patent, and the '207 patent. Compare JX-0003 at Cls. 1, 4, 26
`with JX-0004 at Cls. l, 15 and JX-0005 at Cl. 1.
`
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`Broadly speaking, the asserted claims of the '228 patent are apparatus claims directed to a
`system for determining the surface topology and associated color of a three dimensional structure.
`See JX-0003 at Cls. 1, 4, 26. The asserted claims of the '456 patent are substantially similar
`apparatus claims that i nclude language specifying that the three dimensional structure is a "dental
`structure�" See JX-0004 at Cls. 1, 15. The asserted claim of the '207 patent is a method claim that
`describes a . method for determining the surface topology and associated color of a . three
`dimensional dental structure of using the apparatus described in the asserted claims of the • 456
`patent. See JX-0005 at CL 1 .
`The asserted claim of the '433 patent is also an apparatus claim directed to a system for
`determining the surface topology and associated color of a three dimensional structure. See JX-
`0006 at Cl. 12. The elements of the system recited in the asserted claim of the '433 patent are
`di stinct from those recited in the asserted claims o f the other three color scanner patents. Compare,
`JX-0006 at Cl. 12 with JX-0003 at Cls. l , 4, 26, JX-0004 at Cls. 1, 15, and JX-000S'at CI. I.
`The Gingival Deformation Patents
`2.
`The parties refer to the '470 and '931 patents collectively as the gingival deformation
`paten ts.
`United States Patent Number 6,685,470 entitled "Digitally Modeling the Deformation of
`Gingival Tissue During Orthodontic Treatment," i ssued to Chishti et al. on February 3, 2004. JX-
`0001 at cover page. The patent issued from Appli cation Number 10/280,556 filed on October 24,
`2002, and claims priority to U.S. Patent No. 6,514,074, which was filed on May 14, 1999. Id The
`patent, on its face, i s assigned to Align Technology, Inc. Id
`is also entitled ''Digitally Modeling the
`United States Patent Number 6,948,931
`Deformation ofGingival Tissue During Orthodontic Treatment," and issued to the same inventors
`
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`on September 27, 2005. JX-0002 at cover page. The patent issued from Application Number
`10/691,942 filed on October 22, 2003, and also claims priority to U.S. Patent No. 6,514,074. Id.
`The patent, on its face, is also assigned to Align Technology, Inc. Id
`Both of the gingival deformation patents will expire on May 14, 2019. On September 6,
`2018, I issued Order Number 34 in this investigation, which denied a motion by 3Shape to
`terminate this investigation with respect to the gingival deformation patents based on their
`impending expiration date. At the time of that order, the gingival deformation patents would expire
`six days prior to the May 20, 2019, target date then in effect for-this investigation. I denied
`3Shape's motion on the basis that it was still possible for 3Shape to obtain. a remedy with respect
`to the gingival deformation patents if the final initial determination were to issue early, or the
`Commission were to abbreviate the customary time for its review and consideration of a remedy.
`Order No. 34 at 1. I expressed no opinion as to the likelihood of either scenario. Id.
`Since issuing Order Number 34, a lapse in government appropriations caused the
`Commission to cease regular operations for over a month. As a result of that occurrence, I issued
`an initial detennination extending the target date to July 1, 2019. Order No. 39. The gingival
`deformation patents will now expire forty-eight ( 48) days prior to the target date in this
`investigation. Given this reality, it is a near impossibility that any remedy will issue with respect
`to the gingival defonnation patents. Accordingly, I find that the investigation should be terminated
`with respect to the gingival deformation patents so as to preserve the resources of th� parties arid
`the Commission. See Cerrain Graphics Processors and Prods. Containing Same, Inv. No. 337-
`TA-1099 ("Graphics Processors") Comm'n Notice at 2 (July 17, 2018). The remainder of this
`initial determination on violation and recommended determination on remedy will focus
`exclusively on the color scanner patents.
`
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`D.
`The Technology at Issue
`The technology at issue relates to the determination of both the surface topology and
`associated color of a three dimensional structure, particularly teeth. See, e.g. , JX-0003 at Abstract.
`The color scanner patents acknowledge that prior to the work of the inventors many methods were
`known in the art for determining the surface topology of a three dimensional structure and for
`creating a digital model of that structure. See id at 1 :28-48. The creation of such a digital model
`with accurate color infonnation was difficult, though multiple approaches were known in the art.
`See id. at I :49-2:43.
`The color scanner patents describe an approach to generating a three dimensional model
`with accurate associated color information. The approach described broadly involves obtaining
`three dimensi onal scan data and two dimensional color image data of a structure at nearly i dentical
`times. See id. at 2:61-4:14. Leveraging the knowledge that the three-dimensional scan data and
`two dimensional color image data were obtained close in time to each other, the color scanner
`patents describe obtaining a three-dimensional model of the structure by mapping the two
`dimensional color image data onto the three dimensional scan data See 3:61-4:32. The color
`, scanner patents disclose a number of variations on this approach. See 4:54-12:4.
`E.
`The Accused Products
`Align defines the accused products as "TRIOS3 and Accused Software Products." ClB at
`x. Align ,defines "Accused Software Products" as "Respondents' Ortho and Dental System
`software." Id. And, Align defines "TRIOS3" as "Respondents' TRIOS3 scanners identified at
`JX -0265C at 7-8." Id. at xi. Align accuses Trios scanners of infringing the color scanner p atents,
`and the Accused Software Products ofinfringing the gingival deformation patents. See cm at 23,
`54, 57-58, 73, 83. Because I have terminated this investigation with respect to the gingival
`
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`3SHAPE 1040 3Shape v Align IPR2021-01383
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`deformation patents, the Tios scanne rs are the only re maining accuse d products in this
`inve stigation.
`F.
`The Domestic Industry Products
`Align contends that i ts iTero Ele ment scanners practice the inventions claimed in the color
`scanner patents in satisfaction of the te chnical prong of the domestic industry requirement. CIB
`at 47, 56, 58, 64, 98. Align re li e s on "Align Software," which it define s as "Align's ClinChe ck,
`Treat, and Outcome Simulator software," to satisfy the te chnical prong of the dome stic industry
`re quirement for the gingival deformation patents. Id at 87, 98. Be cause I have tenninated this
`investigation with re spe ct to the gingival deformation patents, the iTero Ele ment scanne rs are the
`only remaining dome stic industry products in this inve stigation. 1
`II.
`JURISDICTION & IMPORTATION
`A.
`Subject Matter Jurisdiction
`Se ction 337 confers subj e ct matter jurisdiction on the Commission to inve stigate, and if
`appropriate, to provide a re medy for, unfair acts and unfair me thods of competition in the
`importation, the sale for importation, or the sale after importation of article s into the Unite d State s.
`See 19 U.S.C. §§ 1337(a)(l)(B) and (a)(2). Align filed a complaint alleging a violation of se ction
`3 3 7( a). Accordingly, the Com.mission has subj e ct matter jurisdiction over this inve stigation under
`se ction 337 of the Tariff Act of 1 930. See Amgen, Inc. v. Int'/. Trade Comm 'n, 902 F.2d 1 532,
`1536 (Fe d. Cir. 1990).
`
`1 Align also ambiguously include s the "Invisalign Syste m" as a dome stic industry product at
`various points in its briefing. As I explain in more de tail in my analysis of the economic prong of
`the dome stic industry require ment, I do not consider the "Invisalign System" to b e a dome stic
`industry product relevant to this investigation.
`
`15
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`3SHAPE 1040 3Shape v Align IPR2021-01383
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`B.
`Personal Jurisdiction
`3Shape has appeared and participated in thi s investigation. The Commission therefore has
`persona l j urisdiction o ver 3Shape. See, e.g., Certain Optical Disk Controller Chip�· & phipsets &
`Prods. Containing Same, Including DVD Players & PC Optical Storage Devices, Inv. No. 337-
`T A-506, ID al 4-5 (May 1 6, 2005 ) ( unreviewed in relevant part).
`C.
`In Rem Jurisdiction
`3Shape does not dispute that the Commi ssion has in rem j urisdiction over the accused Trios
`scanners that have been imported in to the U nited States. See RPB at 37 ("3Shape does not disp ute
`'that 3Shape Trio s A/S se