Paper No._______
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
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`MEDIVIS, INC.
`Petitioner
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`v.
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`NOVARAD CORP.
`Patent Owner
`
`US Patent No. 11,004,271
`
`Inter Partes Review No. IPR2023-00042
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`_______________
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`
`REPLY IN SUPPORT OF
`PETITIONER’S MOTION TO EXCLUDE
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`ME1 47351420v.4
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MEDIVIS, INC.
`Petitioner
`
`v.
`
`NOVARAD CORP.
`Patent Owner
`
`US Patent No. 11,004,271
`
`Inter Partes Review No. IPR2023-00042
`
`_______________
`
`
`REPLY IN SUPPORT OF
`PETITIONER’S MOTION TO EXCLUDE
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`ME1 47351420v.4
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`Attorney Docket No. 127971-00012
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`Patent No. 11,004,271
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`TABLE OF CONTENTS
`Page
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`INTRODUCTION ........................................................................................... 1
`I.
`NOVARAD ADMITTED ALL OF MEDIVIS’S MATERIAL FACTS ........ 1
`II.
`III. ADMISSIBILITY OF EXPERT TESTIMONY IS GOVERNED BY
`THE FEDERAL RULES AND CASELAW ................................................... 2
`IV. MEDIVIS’S DEFINITION OF A POSA IS UNDISPUTED ......................... 2
`V.
`THE MULUMUDI DECLARATION SHOULD BE EXCLUDED .............. 3
`VI. THE ROSENBERG DECLARATION SHOULD BE EXCLUDED ............. 5
`VII. CONCLUSION ................................................................................................ 5
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`Patent No. 11,004,271
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` Attorney Docket No. 127971-00012
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`TABLE OF MEDIVIS EXHIBITS
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`1002
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`1003
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`1004
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`1005
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`1007
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`1008
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`Description
`Number
`1001 US Patent No. 11,004,271, claiming priority to March 30, 2017
`(the ‘271 Patent)
`Excerpts of File history of Application No. 16/574,524, now
`the ‘271 Patent
`Excerpts of File history of Application No. 15/894,595, now
`U.S. Patent No. 10,475,244, through which the ‘271 Patent
`claims priority
`Excerpts of File history of Application No. 15/474,702, filed
`on March 30, 2017, and now U.S. Patent No. 9,892,564,
`through which the ‘271 Patent claims priority
`Excerpt of Amira 5 User’s Guide title through Chapter 2
`(Visual Imaging 2009) (“Amira”)
`1006 US Patent Application Publication No. US 2016/0191887 A1
`to Casas, published on June 30, 2016 (“Casas”)
`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 Slicer-Visualization” aka “3D Visualization”)
`International Publication No. WO 2015/164402 A1 to Doo et
`al., published on October 29, 2015 (“Doo”)
`1009 X. Chen et al., “Development of a Surgical Navigation System
`Based On Augmented Reality Using an Optical See-Through
`Head-Mounted Display,” 55 JOURNAL OF BIOMEDICAL
`INFORMATICS 124-131 (2015) (“Chen”)
`1010 Main Application GUI for 3D Slicer
`<https://www.slicer.org/wiki/Documentation/4.6/Slicer/Applic
`ation/MainApplicationGUI> (last edited 7 November 2016)
`(“3D Slicer GUI” aka “3D Slicer”)
`E. Azimi et al., “Augmented Reality Goggles with an
`Integrated Tracking System for Navigations in Neurosurgery,”
`IEEE VIRTUAL REALITY 123-124, 123 (IEEE 2012) (“AR
`Goggle for Neurosurgery”).
`1012 Declaration of Peter Kazanzides Ph.D.
`1013
`Curriculum Vitae of Peter Kazanzides Ph.D.
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`1011
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`Patent No. 11,004,271
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` Attorney Docket No. 127971-00012
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`TABLE OF MEDIVIS EXHIBITS
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`Number
`1014
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`Description
`Email message entitled “Novarad v. Medivis” and dated
`August 3, 2022, from counsel for Novarad, Brett Davis, to
`counsel for Medivis, Brian Lemon and others.
`1015 Declaration of Christopher Fraiser (May 22, 2023) [served May
`22, 2023]
`Page Vault capture of Slicer.org Main Applications GUI
`[served May 22, 2023]
`Page Vault capture of Slicer.org Acknowledgements [served
`May 22, 2023]
`Page Vault capture of Slicer.org Release Details Slicer 4.6.0
`[served May 22, 2023]
`Page Vault capture of Google Search Results 3D Visualization
`and Training [served May 22, 2023]
`1020 A. Federov et al., “3D Slicer as an image Computing Platform
`for the Quantitative Imaging Network,” 30 MAGNETIC
`RESONANCE IMAGING 1323-1341 (2012) [served May 22, 2023]
`Supplemental Declaration of Peter Kazanzides Ph.D. (May 22,
`2023) [served May 22, 2023]
`Transcript of the Deposition of Mahesh S. Mulumudi, M.D.
`(September 19, 2023) g
`1023 Declaration of Page Vault Representative Todd W. Price (May
`19, 2023) (including publicly-accessible complete copies of
`Exhibit 1007, 3D Slicer-Visualization, and of Exhibit 1005,
`Amira) [served May 22, 2023]
`1024 Declaration of Internet Archive Representative Nathaniel E
`Frank-White (May 16, 2023) (including publicly-accessible
`complete copy of Exhibit 1005, Amira) [served May 22, 2023]
`The Britannica Dictionary Definition of “Confine” from
`<https:/www.britannica.com/dictionary/confine> (downloaded
`9/7/23).
`1026 Merriam-Webster Dictionary Definition & Meaning of
`“Confined” from <https:/www.merriam-
`webster.com/dictionary/confined> (downloaded 9/7/23).
`Cambridge English Dictionary Definition of “Confine” from
`<https://dictionary.cambridge.org/us/dictionary/english/confine
`> (downloaded 9/7/23).
`
`1016
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`1017
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`1018
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`1019
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`1021
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`1022
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`1025
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`1027
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`TABLE OF MEDIVIS EXHIBITS
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`Description
`Number
`1028 Declaration of Pamela Keyl (October 10, 2023)
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`ME1 47351420v.4
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`iv
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`Patent No. 11,004,271
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`I.
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`INTRODUCTION
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`Attorney Docket No. 127971-00012
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`Contrary to Novarad’s arguments, opinions on the perspective of a POSA
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`are admissible only when offered by a POSA. Having waived the right to
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`challenge Medivis’s definition of a POSA, Novarad argues for the first time in its
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`opposition that Mulumudi and Rosenberg each qualify as a POSA—without
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`explaining how either satisfies the undisputed definition. Novarad has never
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`argued any definition of a POSA in this matter, and neither of its experts qualifies
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`as a POSA under the other’s post hoc definitions in their supplemental declarations.
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`Neither Mulumudi’s “perspective of an actual medical doctor” nor
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`Rosenberg’s alleged “understanding of augmented reality” (Opp., 1) is sufficient to
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`qualify them as a POSA. Novarad does not argue that either proposed expert has
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`the required AR device experience. Because neither expert qualifies as a POSA,
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`their opinions regarding the perspective of a POSA must be excluded. The Board
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`must, therefore, exercise its gatekeeping role and exclude both Mulumudi’s and
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`Rosenberg’s opinions (as declared in Exhibits 2002, 2004, 2008, and 2009)
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`because they lack the relevance and reliability required for admission.
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`II. NOVARAD ADMITTED ALL OF MEDIVIS’S MATERIAL FACTS
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`Rule 42.23(a) requires that any opposition to a motion that contains a
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`statement of material facts (SOMF) include “a listing of facts that are admitted,
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`denied, or cannot be admitted or denied” and provides that “[a]ny material fact not
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`specifically denied may be considered admitted.” Even though, in its motion to
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`Attorney Docket No. 127971-00012
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`exclude (MTE), Medivis specifically notified Novarad that “[a]ny material facts
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`not specifically denied should be deemed admitted” (MTE, 15), Novarad did not
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`specifically deny any of the facts in Medivis’s SOMF and therefore all of the facts
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`in Medivis’s SOMF should be deemed admitted.
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`III. ADMISSIBILITY OF EXPERT TESTIMONY IS GOVERNED BY
`THE FEDERAL RULES AND CASELAW
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`The Federal Rules require the Board to address admissibility of expert
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`testimony before any consideration of the weight of that evidence. See MTE, 7-9.
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`Novarad admits that Rule 702 applies in an IPR. Opp., 4 (citing FRE 702). The
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`Federal Circuit further requires that to opine on the perspective of a POSA, “an
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`expert must … possess ordinary skill in the art.” Kyocera Senco Industrial Tools
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`Inc. v. ITC, 22 F.4th 1369, 1377 (Fed. Cir. 2022). The cases that Novarad cites, for
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`the incorrect proposition that challenges to an expert’s qualifications go to weight
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`not admissibility, conflict with the controlling Federal Circuit precedent and Rule
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`702, as clarified in the recent amendment.
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`IV. MEDIVIS’S DEFINITION OF A POSA IS UNDISPUTED
`Novarad has never disputed Medivis’s POSA definition and has not
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`proposed a specific definition of its own, likely because no reasonable definition
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`would qualify both of its proffered experts. Mulumudi’s and Rosenberg’s
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`proposed definitions conflict with each other. See Ex. 2009, ¶ 5; Ex. 2008, ¶ 5.
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`Mulumudi does not qualify under Rosenberg’s definition (Ex. 2008 ¶ 5, requiring
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`academic degrees that Mulumudi does not have), and Rosenberg does not qualify
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`under Mulumudi’s (Ex. 2009 ¶ 5, requiring familiarity with “conventional medical
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`imaging data and visualization of that data for use during a medical procedure,”
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`which Rosenberg never claimed). This conflict confirms that Novarad’s experts
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`did not apply consistent or correct standards when opining on the perspective of a
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`POSA. And as discussed below, neither qualifies under Medivis’s definition, the
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`only definition either party actually proffered in this case.
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`V. THE MULUMUDI DECLARATION SHOULD BE EXCLUDED
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`The undisputed definition of a POSA requires “a bachelor’s degree in
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`computer science, electrical engineering, or a related field.” But “Mulumudi is not
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`a computer science or electrical engineering major.” Opp., 7. Mulumudi’s
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`medical degree does not qualify as a degree “related” to computer science or
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`electrical engineering, and Novarad’s
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`speculation
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`that “the
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`[required]
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`undergraduate degrees would not alter [Mulumudi’s] opinion” (id.) is irrelevant
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`and further demonstrates the unreliability of those opinions.
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`Another requirement for a POSA is “several years of experience in the
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`design, development, and study of augmented reality devices.” Novarad makes
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`much of Mulumudi’s experience with “augmented reality with biofeedback.” Opp.,
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`2, 7. But while Mulumudi’s CV uses the words “augmented reality” in two
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`headings, the underlying descriptions of his actual experience include only VR.
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`Attorney Docket No. 127971-00012
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`See Ex. 2003, 1, 3 (discussing only VR experience). According to Novarad, “VR
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`solutions are not solutions to the challenges of projecting medical imaging onto a
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`real patient in an AR environment.” Sur-reply, 20, 22 (citing Ex. 2004, ¶ 119).
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`Novarad cannot now conflate AR and VR to qualify Mulumudi.
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`Mulumudi claims that he qualifies as a POSA because “the ’271 Patent does
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`not disclose new hardware, but new software.” Opp., 8. But, unlike the degree
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`required by the undisputed POSA definition, Mulumudi’s medical degree does not
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`prove an understanding of AR device software. Mulumudi, therefore, does not
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`qualify as a POSA because he lacks necessary qualifications and experience.
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`Additionally, Mulumudi was not familiar with the 3D Slicer software
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`application. Ex. 1022, 130:6-8, 131:3-6, 131:7-10. As even Novarad admits, a
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`POSA is “presumed to have known the relevant art at the time of the invention.”
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`Opp., 3. Medivis’s petition stated “[a] POSA would have been familiar with the
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`3D Slicer application and its ability to load and display data for a user.” Pet., 17
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`(citing Ex. 1012, ¶ 41). Contrary to Novarad’s argument, this is not a new addition
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`to the POSA definition. Rather, Mulumudi’s lack of familiarity with this widely-
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`known application shows that he is not a POSA because he is unfamiliar with all of
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`the relevant art. And even if Mulumudi qualified as a POSA, to reliably opine on
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`obviousness, he would at least need to be familiar with the cited references. He
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`was not. Ex. 1022, 150:10-21. His declaration should be excluded.
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`Attorney Docket No. 127971-00012
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`VI. THE ROSENBERG DECLARATION SHOULD BE EXCLUDED
`Novarad admits that Rosenberg lacks experience with “augmented reality
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`devices.” Opp., 12 (citing Ex. 2008, ¶ 5). Rosenberg admitted that he is “not an
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`expert in the specifics of medical imaging.” Opp., 14 (citing Ex. 2004, ¶ 79).
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`Contrary to Novarad’s suggestion (Opp., 13-14), Rosenberg’s work in “application
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`areas, including … healthcare,” and his corporate experience related to digital
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`stethoscopes and medical records—which are not AR devices—do not demonstrate
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`a familiarity with conventional medical imaging data and visualization. For
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`example, a stethoscope collects audio—not imaging—data. See, e.g., Opp., 6
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`(“acoustic collection system [e.g., stethoscope]”). He is not a POSA and his
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`declaration should be excluded.
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`VII. CONCLUSION
`Because neither of Novarad’s experts qualifies as a POSA here, the Board
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`should exclude Novarad’s proffered opinions (as stated in Exhibits 2002 and 2004,
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`as well as their supplemental declarations, Exhibits 2008 and 2009). If admitted,
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`each opinion should be given no weight. All of the material facts in Medivis’s
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`motion should be deemed admitted.
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`Dated: January 16, 2024
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`ME1 47351420v.4
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`Respectfully submitted,
`By: /s/ Kia L. Freeman
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`Kia L. Freeman
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`Registration No. 47,577
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`Attorney for Petitioner
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`CERTIFICATE OF COMPLIANCE
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`The undersigned hereby certifies that the foregoing Reply in Support of
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`Petitioner’s Motion to Exclude—excluding the Table of Contents, the Table of
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`Authorities, the Table of Exhibits, this Certificate, and the Certificate of Service
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`(which are excluded from the word count by 37 CFR 42.24(c))—includes 5 pages
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`or less in accordance with 37 CFR 42.24(c)(2).
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`By:
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`/s/ Kia Freeman /s/
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`Kia L. Freeman
`Registration No. 47,577
`Attorney for Petitioner
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Reply in
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`Support of Petitioner’s Motion to Exclude (including the Certificate of
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`Compliance) was served on January 16, 2024 by transmitting a copy by e-mail to
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`the email addresses of the patent owner’s attorneys of record in the patent owner’s
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`latest mandatory notice:
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`joseph.harmer@tnw.com; and
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`hansen@tnw.com
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`/s/ Kia Freeman /s/
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`Kia L. Freeman
`Registration No. 47,577
`Attorney for Petitioner
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