UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MEDIVIS, INC.
`Petitioner
`
`v.
`
`NOVARAD CORP.
`Patent Owner
`
`Inter Partes Review No. IPR2023-00042
`US Patent No. 11,004,271
`
`Inter Partes Review No. IPR2023-00045
`US Patent No. 10,945,807
`
`_______________
`
`SUPPLEMENTAL DECLARATION OF PETER KAZANZIDES, Ph.D.
`
`ME1 45038924v.1
`
`Medivis Exhibit 1021
`
`1
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MEDIVIS, INC.
`Petitioner
`
`v.
`
`NOVARAD CORP.
`Patent Owner
`
`Inter Partes Review No. IPR2023-00042
`US Patent No. 11,004,271
`
`Inter Partes Review No. IPR2023-00045
`US Patent No. 10,945,807
`
`_______________
`
`SUPPLEMENTAL DECLARATION OF PETER KAZANZIDES, Ph.D.
`
`ME1 45038924v.1
`
`Medivis Exhibit 1021
`
`1
`
`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`1.
`
`I, Peter Kazanzides, Ph.D., have been working with the 3D Slicer
`
`platform for almost two decades. During that time, I have personally taken
`
`advantage of 3D Slicer training and documents.
`
`3D Slicer Background
`2.
`In 2012, several people involved in the development of 3D Slicer
`
`wrote an article “to serve as a brief summary and introduction to 3D Slicer
`
`capabilities.” Exhibit 1020, A. Federov et al., “3D Slicer as an image Computing
`
`Platform for the Quantitative Imaging Network,” 30 MAGNETIC RESONANCE
`
`IMAGING 1323-1341 (2012). The 2012 article notes that “Over the years, 3D Slicer
`
`has gained broad acceptance in the medical imaging research community.” Exhibit
`
`1020 at 1339 col. 2.
`
`3.
`
`The 2012 article explained that “3D Slicer is a free open-source
`
`extensible software application for medical image computing and visualization.
`
`Slicer emerged as a culmination of several independent projections that focused
`
`separately on image visualization, surgical navigation and graphical user interface
`
`(GUI).” Exhibit 1020 at 1324 col. 1.
`
`4.
`
`The 2012 article includes a 3D Slicer trademark. Exhibit 1020 at
`
`FIGS. 2, 4, and 5.
`
`ME1 45038924v.1
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`1
`
`Medivis Exhibit 1021
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`2
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`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`5.
`
`The 2012 article explained that “Documentation, training and user
`
`support are high priorities for the Slicer community. Hands-on training sessions
`
`are organized regularly as part of ongoing outreach initiatives at major
`
`conferences, such as the annual Radiological Society of North American (RSNA),
`
`Medical Image Computing and Computer Assisted Interventions (MICCAI) and
`
`International Society for Optics and Photonics (SPIE) meetings, or in response to
`
`request by host institutions at both national and international venues. … Remote
`
`learning of 3D Slicer is supported by online resources and community mailing
`
`lists. Focused training materials that include sample data sets and step-by-step
`
`instruction are available for basic Slicer operation as well as advanced workflows.”
`
`Exhibit 1020 at 1327 col. 2.
`
`6.
`
`As to how to learn more about 3D Slicer, the 2012 article explained
`
`that “Various training and support resources are available to the users and
`
`developers to ease the learning curve. … The interested reader is encouraged to
`
`explore the various resources available from the home page of the 3D Slicer
`
`project: http://slicer.org.” Exhibit 1020 at 1327 col. 2.
`
`ME1 45038924v.1
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`2
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`Medivis Exhibit 1021
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`3
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`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`7.
`
`The version 4.x Acknowledgements on the 3D Slicer website requests
`
`that users cite both “the Slicer web site (http://slicer.org) and [the 2012 article]” to
`
`acknowledge 3D Slicer as a platform. Exhibit 1017,
`
`“Documentation/4.x/Acknowledgements,” available at
`
`<www.slicer.org/wiki/Documentation/4.x/Acknowledgements>, 2.
`
`8.
`
`By 2015, 3D Slicer was recognized as a “well-known, free and open-
`
`sourced software package … for visualization and medical image computing.”
`
`Exhibit 1009 at 131 col. 1. Any written discussion of 3D Slicer typically included
`
`the “http://www.slicer.org” website address as a source for information on 3D
`
`Slicer. See, e.g., Exhibit 1009 at 131 col. 1.
`
`9.
`
`According to Exhibit 1009 (in both IPR2023-0042 and IPR2023-
`
`00045), in the “several years [before 2015], many research groups ha[d] developed
`
`loadable extension modules based on 3D Slicer, for example, DicomRtExport
`
`module enables basic DICOM RT studies to local storage ….” Exhibit 1009 at 8.
`
`Exhibit 1007 in IPR2023-00042 — S. Pujol, Ph.D. et al., 3D
`Visualization of DICOM Images for Radiological Applications (Surgical
`Planning Laboratory, Brigham and Women’s Hospital, Boston,
`Massachusetts 2014) (“3D Visualization”)
`10.
`Exhibit 1007 in IPR2023-0042 is entitled “3D Visualization of
`
`DICOM Images for Radiological Applications.” (All references to Exhibit 1007
`
`hereinafter refer to Exhibit 1007 in IPR2023-00042). Part II of Exhibit 1007
`
`ME1 45038924v.1
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`3
`
`Medivis Exhibit 1021
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`4
`
`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`describes “3D Data Loading and visualization of DICOM images.” Exhibit 1007,
`
`1st Slide 3. Exhibit 1007 references the use of four “DICOM” datasets. Exhibit
`
`1007, 2d Slide 3.
`
`11.
`
`Exhibit 1007 is the PDF available from the 3D Slicer website at
`
`<https://www.slicer.org/w/img_auth.php/3/3a/3DVisualizationDICOM_SoniaPujol
`
`.pdf>. Exhibit 1007 directs users back to “www.slicer.org.” Exhibit 1007, at Slide
`
`126.
`
`12.
`
`Exhibit 1007 identifies itself as a “tutorial.” Exhibit 1007 at Slides 2,
`
`58, 60-78. Exhibit 1007 includes the 3D Slicer trademark on many pages. See,
`
`e.g., Exhibit 1007 at Slides 6, 7, 10, 17, 18, 19, 22-30, 32-36, 121.
`
`13.
`
`Exhibit 1007 identifies the Surgical Planning Laboratory (SPL) of
`
`Brigham and Women’s Hospital, Boston, Massachusetts as its publisher. The
`
`version 4.x Acknowledgements on the 3D Slicer project website identify “SPL” as
`
`a group “Contributing to the Core Engineering of Slicer in a Major Way.” Exhibit
`
`1017, at 2. Exhibit 1007 includes the “SPL” trademark on every page. Exhibit
`
`1007 includes “©2012-2014 Surgical Planning Laboratory, ARR” on almost every
`
`page.
`
`14.
`
`Exhibit 1007 states that “Slicer started as a research project between
`
`the Surgical Planning Lab [(SPL)] (Harvard) and CSAIL (MIT).” Exhibit 1007,
`
`Slides 9, 10. According to the 2012 article introducing 3D Slicer, “Since 1999,
`
`ME1 45038924v.1
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`4
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`Medivis Exhibit 1021
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`5
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`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`Slicer ha[d] been under continuous development at the SPL ….” Exhibit 1020 at
`
`1324 col. 1.
`
`15.
`
`Exhibit 1007 discloses that, as of 2014, 3D Slicer is a “Multi-
`
`institution effort to share the latest advances in image analysis with the clinical and
`
`scientific community.” Exhibit 1007, Slide 10.
`
`16.
`
`Exhibit 1007 identifies its authors as S. Pujol, Ph.D., Kitt Shaffer,
`
`MD, Ph.D., and Ron Kikinis, MD. Exhibit 1007 at Slide 2.
`
`17.
`
`Exhibit 1007 author Sonia Pujol, PhD, is also one of the authors of the
`
`2012 article. Exhibit 1020. The version 4.x Acknowledgements on the 3D Slicer
`
`project website identify Sonia Pujol as the “Director of Training.” Exhibit 1017, at
`
`2. Exhibit 1007 directs “Questions and comments [to] spujol@bwh.harvard.edu.”
`
`Exhibit 1007, at Slide 126.
`
`18.
`
`Exhibit 1007 author Ron Kikinis, MD, is also one of the authors of the
`
`2012 article. Exhibit 1020. According to the 2012 article introducing 3D Slicer,
`
`“Since 1999, Slicer ha[d] been under continuous development … under the
`
`leadership of Ron Kikinis.” Exhibit 1020 at 1324 col. 1. The version 4.x
`
`Acknowledgements on the 3D Slicer project website identify Ron Kikinis as the
`
`“Principal Investigator.” Exhibit 1017, at 1. Exhibit 1007 references “PI: Ron
`
`Kikinis, M.D.” Exhibit 1007, at Slide 11.
`
`ME1 45038924v.1
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`5
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`Medivis Exhibit 1021
`
`6
`
`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`19.
`
`The 2012 article states: “Since its inception in the late 1990s, 3D
`
`Slicer has been evolving, with major architectural, functional and GUI redesigns
`
`occurring every 4-5 years. The current (fourth) generation of Slicer was released
`
`in November 2011.” Exhibit 1020 at 1327 col. 1.
`
`20.
`
`Exhibit 1007 discloses “Slicer Training events” at three major
`
`international conferences in 2014: RSNA, MICCAI, and SPIE. Exhibit 1007 at
`
`Slide 14. Exhibit 1007 discloses that a hands-on refresher course at RSNA
`
`included “3D Visualization of DICOM Images for Radiological Applications,”
`
`which is the title of the tutorial itself. Exhibit 1007, at Slide 15. Exhibit 1007
`
`references a 2014 RSNA directory:
`
`“c:\3DSlicerData_RSAN2014\3DVisualizationDICOM_Monday_Dec1.” Exhibit
`
`1007, at Slide 107.
`
`21.
`
`Exhibit 1007 introduces the user to “3DSlicer version 4.3.” Exhibit
`
`1007 at Slide 7. Exhibit 1007 welcomes the user to “Slicer4,” and more
`
`particularly to “Slicer4.3.1” and “Slicer4.3.1.1.” Exhibit 1007 at Slides 17, 19, 20.
`
`Exhibit 1007 discloses Slicer4 download stats up to September 2014. Exhibit 1007
`
`at Slide 10.
`
`22.
`
`The 2012 article explained that “Wiki-based Web pages accompany
`
`every module of the 3D Slicer, providing reference documentation of functionality
`
`and usage examples.” Exhibit 1020 at 1327 col. 2.
`
`ME1 45038924v.1
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`6
`
`Medivis Exhibit 1021
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`7
`
`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`23.
`
`The Release Details available on the 3D Slicer website confirms the
`
`2012 article’s statement that the fourth generation of Slicer was released in
`
`November 2011. Exhibit 1018, “Release Details – Slicer Wiki” available at
`
`<https://www.slicer.org/wiki/Release_Details#Slicer_4.6.0>, at 8 (version 4.0.0
`
`released 2011/11/27). The Release Details disclose that 3D Slicer version 4.3 was
`
`released in 2013, and 3D Slicer version 4.4 was released in November of 2014.
`
`Exhibit 1018 at 4-5.
`
`24. Additionally, I have reviewed pages 1-6 and 408-531 of Exhibit 1023.
`
`I have compared pages 408-531 of Exhibit 1023 to Exhibit 1007 in IPR2023-
`
`00042. Based on that comparison, I can confirm that this authenticated Page Vault
`
`capture at pages 408-531 of Exhibit 1023 is the same as Exhibit 1007 except for
`
`what appears to be added exhibit markings.
`
`25. Additionally, I performed a google search for the phrase “3D
`
`Visualization of DICOM images for Radiological applications” which is the title
`
`on the face of Exhibit 1007.
`
`26.
`
`I then limited the date range of this search to January 1, 2012 –
`
`December 31, 2014 and reviewed the first page of the results. I can confirm that
`
`Exhibit 1019 is consistent with the first page of results for that search, and that the
`
`first result is the same.
`
`ME1 45038924v.1
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`7
`
`Medivis Exhibit 1021
`
`8
`
`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`27.
`
`I note that the first search result on Exhibit 1019 is the URL for
`
`Exhibit 1007 and for pages 408-531 of Exhibit 1023. See, e.g. Exhibit 1023, at 2.
`
`I visited this URL and confirmed that it directs to the same document as Exhibit
`
`1007 and pages 408-531 of Exhibit 1023.
`
`28.
`
`I note that the first search result displayed in Ex. 1019 shows the date
`
`September 30, 2014 for the URL that directs to Exhibit 1007 and pages 408-531 of
`
`Exhibit 1023. It is my understanding from Google development documents that
`
`dates for Google search results are determined “using a variety of factors,
`
`including but not limited to: any prominent date listed on the page itself or dates
`
`provided by the publisher through structured markup.” See
`
`<https://developers.google.com/search/blog/2019/03/help-google-search-know-
`
`best-date-for>.
`
`29. Because the document that appears at this URL, Exhibits 1007 and
`
`pages 408-531 of Exhibit 1023, does not include the date “September 30, 2014” on
`
`the face of the document, it is my conclusion that this date was provided by the
`
`publisher through structured markup at the time it was published and therefore that
`
`this document became publically available on or around that date, September 30,
`
`2014.
`
`ME1 45038924v.1
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`8
`
`Medivis Exhibit 1021
`
`9
`
`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`30. Based on all of the foregoing, in my opinion, Exhibit 1007 in
`
`IPR2023-00042 is a 3D Slicer tutorial that was made available to interested people
`
`in 2014.
`
`Exhibit 1004 in IPR2023-00045 — S. Pujol, Ph.D. et al., 3D
`Visualization of DICOM Images for Radiological Applications (Surgical
`Planning Laboratory, Brigham and Women’s Hospital, Boston,
`Massachusetts 2014) (“3D Visualization”)
`31.
`I have compared Exhibit 1004 in IPR2023-00045 with Exhibit 1007 in
`
`IPR2023-00042. Based on my comparison, I conclude that Exhibit 1004 in
`
`IPR2023-00045 is the same as Exhibit 1007 in IPR2023-00042 except for what
`
`appear to be added exhibit numbers. Accordingly, all of the statements above
`
`regarding Exhibit 1007 in IPR2023-00042 also apply to Exhibit 1004 in IPR2023-
`
`00045.
`
`32.
`
`I have compared pages 408-531 of Exhibit 1023 to Exhibit 1004 in
`
`IPR2023-00045. Based on that comparison, I can confirm that this authenticated
`
`Page Vault capture at pages 408-531 of Exhibit 1023 is the same as Exhibit 1004
`
`in IPR2023-00045 except for what appears to be added exhibit markings.
`
`33. Based on all of the foregoing, in my opinion, Exhibit 1004 in
`
`IPR2023-00045 is a 3D Slicer tutorial that was made available to interested people
`
`in 2014.
`
`ME1 45038924v.1
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`9
`
`Medivis Exhibit 1021
`
`10
`
`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`Exhibit 1010 in IPR2023-00045 — Main Application GUI for 3D Slicer
`<https://www.slicer.org/wiki/Documentation/4.6/Slicer/Application/Mai
`nApplicationGUI> (last edited 7 November 2016) (“3D Slicer”)
`34.
`Exhibit 1010 in IPR2023-00042 is a print out of a Slicer Wiki
`
`webpage available from the 3D Slicer website at
`
`<https://www.slicer.org./wiki/Documentation/4.6/SlicerApplication/MainApplicati
`
`onGUI>. (All references to Exhibit 1010 hereinafter refer to Exhibit 1010 in
`
`IPR2023-00042). Exhibit 1010 includes the 3D Slicer trademark. Exhibit 1010, at
`
`1.
`
`35.
`
`Exhibit 1010 refers the reader to a different website address “[f]or the
`
`latest Slicer documentation ….” Exhibit 1010, at 1.
`
`36.
`
`Exhibit 1010 is entitled “Documentation/4.6/SlicerApplication/
`
`MainApplicationGUI.” Exhibit 1010, at 1. Based on the title, I understand that it
`
`was written about the Main Application GUI for 3D Slicer version 4.6.
`
`37.
`
`Exhibit 1010 discloses that it “was last edited on 7 November 2016, at
`
`8:06.” Exhibit 1010, at 7.
`
`38.
`
`The Release Details disclose that 3D Slicer version 4.6 was last
`
`released on November 8, 2016. Exhibit 1018 at 3. It makes sense that
`
`documentation of 3D Slicer version 4.6 was last edited before that version was
`
`released.
`
`ME1 45038924v.1
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`10
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`Medivis Exhibit 1021
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`11
`
`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`39.
`
`Furthermore, I have reviewed Exhibit 1016 and compared it to Exhibit
`
`1010. Based on that comparison, I can confirm that the authenticated Page Vault
`
`capture is identical in all material respects to Exhibit 1010.
`
`40. Based on all of the foregoing, in my opinion, Exhibit 1010 is
`
`documentation for a version of 3D Slicer that was made available to interested
`
`people on November 8, 2016.
`
`ME1 45038924v.1
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`11
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`Medivis Exhibit 1021
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`12
`
`
`
`Patent No. 11,004,271
`Patent No. 10,945,807
`
`IPR2023-00042
`IPR2023-00045
`
`I hereby declare that all statements made herein of my own knowledge are
`
`true and that all statements made on information and belief are believed to be true;
`
`and further that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under § 1001 of Title 18 of the United States Code.
`
`Date: May 22, 2023
`
`_______
`
`_______________
`
`Peter Kazanzides, Ph.D.
`
`ME1 45038924v.1
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`12
`
`Medivis Exhibit 1021
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`13
`
`
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