`
`
`
`
`
`
`
`
`Paper No._______
`
`
`
`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
`
`_______________
`
`
`PETITIONER’S
`MOTION TO EXCLUDE
`
`
`ME1 47194821v.2
`
`
`
`Patent No. 11,004,271
`
`
`
`
`
`Attorney Docket No. 127971-00012
`
`TABLE OF CONTENTS
`
`
`Page
`
`
`INTRODUCTION ........................................................................................... 1
`
`
`
`I.
`
`II.
`
`STATEMENT OF MATERIAL FACTS ........................................................ 2
`
`III.
`
`STANDARD FOR ADMISSION OF EXPERT OPINION ........................... 7
`
`IV. NOVARAD WAIVED THE RIGHT TO DISPUTE MEDIVIS’S
`DEFINITION OF A POSA ............................................................................. 9
`
`V. MULUMUDI’S OPINIONS DO NOT QUALIFY FOR ADMISSION ....... 10
`
`A. Mulumudi Opinions on the Perspective of a POSA Are
`Inadmissible Because He Lacks the Required Qualifications ............ 10
`
`B. Mulumudi’s Opinions Are Not Otherwise Qualified for
`Admission ............................................................................................ 10
`
`C. Mulumudi Relies on His Own Say-So ................................................ 11
`
`D. Mulumudi’s DVR-Related Opinions Are Unreliable ......................... 11
`
`VI. ROSENBERG’S OPINIONS DO NOT QUALIFY FOR
`ADMISSION ................................................................................................. 12
`
`A.
`
`B.
`
`C.
`
`D.
`
`Rosenberg’s Opinions on the Perspective of a POSA Are
`Inadmissible Because He Lacks the Required Qualifications ............ 12
`
`Rosenberg’s Opinions Are Not Otherwise Qualified for
`Admission ............................................................................................ 13
`
`Rosenberg Opined Without Relevant Specialized Knowledge .......... 13
`
`Cognitive Bias Explains How Rosenberg Found a New User
`Interface Requirement in a Non-Existent Claim Term ....................... 14
`
`VII. NOVARAD FAILED TO DISCLOSE THE BASIS FOR ITS
`PROFFERED OPINIONS ............................................................................. 15
`
`VIII. CONCLUSION .............................................................................................. 15
`
`
`
`
`
`ME1 47194821v.2
`
`i
`
`
`
`Patent No. 11,004,271
`
`
` Attorney Docket No. 127971-00012
`
`TABLE OF MEDIVIS EXHIBITS
`
`
`
`
`
`1002
`
`1003
`
`1004
`
`1005
`
`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”)
`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”)
`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.
`
`1007
`
`1008
`
`1011
`
`ME1 47194821v.2
`
`ii
`
`
`
`Patent No. 11,004,271
`
`
`
`
`
` Attorney Docket No. 127971-00012
`
`TABLE OF MEDIVIS EXHIBITS
`
`Number
`1014
`
`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
`
`1017
`
`1018
`
`1019
`
`1021
`
`1022
`
`1025
`
`1027
`
`ME1 47194821v.2
`
`iii
`
`
`
`Patent No. 11,004,271
`
`
` Attorney Docket No. 127971-00012
`
`TABLE OF MEDIVIS EXHIBITS
`
`
`
`
`
`
`
`Description
`Number
`1028 Declaration of Pamela Keyl (October 10, 2023)
`
`ME1 47194821v.2
`
`iv
`
`
`
`Patent No. 11,004,271
`
`
`
`FEDERAL CASES
`
`
`
`Attorney Docket No. 127971-00012
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) ............... 15
`
`In re Nuvasive, Inc., 842 F.3d 1376, 1380-81 (Fed. Cir. 2016) .............................. 10
`
`Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 157 (1999) ............................. 11
`
`Kyocera Senco Industrial Tools Inc. v. International Trade Commission, 22
`F.4th 1369, 1377-78 (Fed. Cir. 2022) ................................................... 8, 9, 10, 13
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1318 (Fed. Cir. 2005) ............................... 14
`
`Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363 (Fed. Cir.
`2008) ..................................................................................................................... 9
`
`RULES
`
`Fed. R. Evidence 104(a) ............................................................................................. 9
`
`Fed. R. Evidence 702 ................................................................................. 8, 9, 11, 13
`
`Committee Notes to 2023 Clarifying Amendment to Fed. R. Evidence 702 ........ 8, 9
`
`REGULATIONS
`
`37 CFR § 42.62(a), (c) ............................................................................................... 9
`
`37 CFR § 42.65(a) .................................................................................................... 15
`
`
`
`
`
`
`
`
`ME1 47194821v.2
`
`v
`
`
`
`Patent No. 11,004,271
`
`I.
`
`INTRODUCTION
`
`
`
`Attorney Docket No. 127971-00012
`
`Patent Owner Novarad relies on declarations of its two proffered experts,
`
`Mulumudi (Exhibit 2002) and Rosenberg (Exhibit 2004), for opinions on the
`
`perspective of a person of ordinary skill in the art (POSA). But Novarad never
`
`challenged Medivis’s definition of a POSA, never disclosed its own definition,
`
`never argued that Mulumudi or Rosenberg qualified as a POSA, and never
`
`disclosed how either defined a POSA in forming his opinions. Neither declarant
`
`qualifies as a POSA under Medivis’s definition of a POSA, which Novarad waived
`
`the right to dispute, because neither declarant has the required technical degree, the
`
`required experience with augmented reality (AR) devices, and the required
`
`understanding of conventional medical imaging data and its visualization.
`
`Further, Mulumudi
`
`remains unfamiliar with
`
`relevant visualization
`
`technology, including 3D Slicer, a well-known, freely-available visualization
`
`platform at the relevant time. Similarly, Rosenberg admitted he is not an expert in
`
`the specifics of medical imaging but opined on that nonetheless. Both declarations
`
`rely on unsupported statements. Neither declaration was reviewed with enough
`
`care to avoid obvious material mistakes.
`
`Novarad failed to satisfy its burden to establish the admissibility of its
`
`proffered declarations. Both declarations should be excluded because they lack the
`
`relevance and reliability required for admission.
`
`ME1 47194821v.2
`
`1
`
`
`
`Patent No. 11,004,271
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`
`
`
`Attorney Docket No. 127971-00012
`
`In its petition, Medivis asserted that a person of ordinary skill in the art
`
`(POSA) would have had three qualifications:
`
`[1] a bachelor’s degree in computer science, electrical engineering, or
`
`a related field with
`
`[2] several years of experience in the design, development, and study
`
`of augmented reality devices and
`
`[3] either (a) familiar[ity] with conventional medical imaging data and
`
`visualization of data for medical procedures or (b) working with a
`
`team including someone with such familiarity.
`
`Pet. 10 (citing Ex. 1012, ¶ 25). Medivis’s definition is based on the opinion of its
`
`expert, Professor Kazanzides, whose qualifications are summarized in the petition.
`
`Pet. 9-10. Kazanzides based his definition on his review of the ‘271 Patent and the
`
`prior art. Ex. 1012, ¶¶ 19-25.
`
`The Board instituted review without deciding the definition of a POSA.
`
`Decision Granting Institution, Paper 7, at 6 (April 24, 2023). Importantly, the
`
`Board cautioned Novarad that “any arguments not raised in the response may be
`
`deemed waived.” Scheduling Order, Paper 8, at 8 (April 24, 2023).
`
`But in its response, despite the Board’s warning, Novarad neither disputed
`
`Medivis’s definition of a POSA nor offered its own definition. Nor did Novarad
`
`argue that either of its proffered experts, Mulumudi and Rosenberg, qualified as a
`
`POSA under any definition. Nonetheless, Novarad still relied on Mulumudi’s and
`
`ME1 47194821v.2
`
`2
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`Rosenberg’s unqualified opinions on the perspective of a POSA. Neither
`
`Mulumudi nor Rosenberg is qualified to opine on how a POSA would view the
`
`‘271 Patent and the cited prior art.
`
`Mulumudi purported to opine from the perspective of a POSA. See, e.g.,
`
`Exhibit 2002, ¶ 30 (“I understand that my opinion must be taken from the
`
`perspective of what would have been known or understood by a person of ordinary
`
`skill in the art [POSA] at the time of the invention.”); see also id., ¶ 35; ¶¶ 38-40;
`
`¶ 42; ¶¶ 44-45; ¶ 47. Despite acknowledging Medivis’s definition of a POSA (Ex.
`
`2002, ¶ 32), Mulumudi never disclosed how he himself had defined a POSA in
`
`forming his opinions. And Mulumudi only claimed to be “qualified to provide
`
`expert opinions on some aspects of the technology described in the ‘271 Patent”
`
`Ex. 2002 ¶ 29 (emphasis added).
`
`Mulumudi presented what he characterizes as an “Overview of The Use of
`
`Augmented Reality (AR) In Medical Practice At The Time of The ’271 Patent.”
`
`Ex. 2002, §IV (title), ¶¶ 48-58. But rather than discussing AR, the overview
`
`instead discussed “direct volume rendering” (DVR). But the phrase “direct
`
`volume rendering” appears nowhere in the ‘271 Patent. The ‘271 Patent does not
`
`disclose that anything was “direct volume rendered” or even just “volume
`
`rendered.” Although Mulumudi cited no support in his overview, he relied on it
`
`throughout his declaration to support his other opinions.
`
`ME1 47194821v.2
`
`3
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`Mulumudi construed four claim terms. Ex. 2002, ¶¶ 66-80, §VI.5
`
`(“Summary Table of Claim Interpretation”). Mulumudi construed two terms as
`
`requiring direct volume rendering. Ex. 2002, §VI.5 (construing “3D data” as
`
`“[d]irect volume rendered … imaging”), ¶ 70 (“‘inner layers of the patient’
`
`requires direct volume rendering”). Mulumudi construed a third term (“being
`
`confined within a virtual 3D shape”) that appears nowhere in the challenged
`
`claims—without recognizing this obvious mistake. Ex. 2002, §VI.5. Mulumudi’s
`
`construction of the fourth term (“being having”) consisted of deleting, without
`
`explanation, one of the two words (i.e., “being”) from that term. Id., ¶ 80.
`
`In Exhibit 2004, Novarad’s other declarant, Rosenberg, similarly purported
`
`to opine from the perspective of a POSA. See, e.g., Exhibit 2004, ¶ 39 (“I
`
`understand that my opinion must be taken from the perspective of what would have
`
`been known or understood by a [POSA] at the time of the invention.”) see also id.,
`
`¶ 45; ¶¶ 48-50; ¶ 52; ¶¶ 54-55; ¶ 57. Despite acknowledging Medivis’s definition
`
`of a POSA (Ex. 2004, ¶ 41),1 Rosenberg did not clearly say how he defined a
`
`POSA in forming his opinions. Notably, Rosenberg did not claim to be qualified
`
`to opine on all of the ‘271 Patent’s technology. Rather, like Mulumudi, he only
`
`claimed to be “qualified to provide expert opinions on some aspects of the
`
`
`1 To the extent that Rosenberg’s possible definition of a POSA (Ex. 2004, ¶ 42) is
`given any credit, then Mulumudi does not qualify as a POSA because he does not
`have “a degree in human factors or human-computer interaction.”
`
`ME1 47194821v.2
`
`4
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`technology described in the ‘271 Patent.” Ex. 2004, ¶ 38 (emphasis added).
`
`Rosenberg presents what he characterized as an “Overview of The Use of
`
`Augmented Reality (AR) At The Time of The ’271 Patent (March 2017).” Ex.
`
`2004, §IV (title), ¶¶ 58-64. Rosenberg has no apparent specialized knowledge of
`
`surgical applications, but he nonetheless focused his overview on surgical
`
`applications. Id. ¶¶ 59-63. Although his overview cited no support, Rosenberg
`
`relied on it throughout the remainder of his declaration.
`
`Rosenberg admitted he is “not an expert in the specifics of medical
`
`imaging” (Ex. 2004, ¶ 79 (emphasis added)), but then construed two claim terms—
`
`namely, “three-dimensional (3D) data” and “inner layer of the patient”—as
`
`specific medical imaging (Ex. 2004, §VI.5). Like Mulumudi, Rosenberg construed
`
`a third term (“being confined within a virtual 3D shape”) that appears nowhere in
`
`the challenged claims—without recognizing this obvious mistake. Id. Like
`
`Mulumudi, Rosenberg’s construction of the fourth term (“being having”) consisted
`
`of deleting one of the two words (i.e., “being”) from that term. Id.
`
`Petitioner Medivis timely objected to Novarad’s declarations (Paper 13,
`
`Petitioner’s Objections (July 25, 2023)), and deposed Mulumudi.
`
`Medivis cross-examined Mulumudi based in part on a petition exhibit, the
`
`Amira User Guide (Exhibit 1005). Unlike the ‘271 Patent, Amira expressly
`
`discloses “direct volume rendering.” See, e.g., Ex. 1005, 6/18-7/19. Medivis
`
`ME1 47194821v.2
`
`5
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`asked Mulumudi about Amira’s three-page section entitled “Volume Rendering,”
`
`which includes an exemplary volume-rendered medical image. See, e.g., Ex. 1005,
`
`37/49-39/512 (Section 2.3.6). Despite the exemplary figures, Mulumudi admitted
`
`that he could identify DVR only by the exact words “direct volume rendering.”
`
`Exhibit 1022, 129:17-130:1 (“Q. Is there any way that you could tell whether the
`
`[‘]volume rendering[’] referenced on page 49 of Amira is direct volume rendering
`
`without the words ‘direct’—the phrase ’direct volume rendering’ being used?
`
`THE WITNESS: No.”) (objection omitted).
`
`On cross-examination, Mulumudi testified that, “in the context of imaging,
`
`three-dimension [3D] is ability to see the object of interest in multiple angles and
`
`multiple depths, and also related to multiple textures.” Exhibit 1022, 35:10-15;
`
`compare Ex. 2002, ¶ 60 (“only a DVR image is 3D”). But Claim 1 includes both
`
`“3D data” and a “3D shape.” See Ex. 1001, 18:55-65. And the exemplary virtual
`
`spatial difference box 116 is not “3D” as Mulumudi construed that term. Id., Fig. 1.
`
`Mulumudi admitted that he was unfamiliar with the Amira visualization
`
`technology except to the extent that he had read the excerpt of its User Guide
`
`(Petition Exhibit 1005), after becoming involved in this IPR. See, e.g., Ex. 1022,
`
`120:14-124:2, 130:3-5 (never used Amira). Mulumudi also admitted that he was
`
`unfamiliar with the 3D Slicer visualization technology (Ex. 1022, 130:6-8, 131:3-6,
`
`
`2 Both of Amira’s two page numbers are cited as “#/#.”
`
`ME1 47194821v.2
`
`6
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`131:7-10) and did not recognize Exhibit 1007, 3D Slicer-Visualization (Ex. 1022,
`
`150:10-21)—despite Medivis’s citing that exhibit both for the state of the art and
`
`as part of its third grounds for unpatentability. Pet., 16-19, 54-69. Mulumudi
`
`agreed that the underlying technology was commonly used by multiple research
`
`groups before the relevant time and attributed his lack of familiarity with 3D Slicer
`
`to the fact that he is not involved in research. Ex. 1022, 147:13-148:9. In effect,
`
`Mulumudi admitted that he is unqualified to discuss the prior art technology.
`
`In its reply, Medivis pointed out that Novarad’s response neither disputed
`
`Medivis’s POSA definition nor qualified Novarad’s proffered declarants to opine
`
`from the perspective of a POSA under any definition. Reply, 1-2.
`
`In its sur-reply, Novarad again did not dispute Medivis’s definition of a
`
`POSA nor argue that either Mulumudi or Rosenberg were qualified to opine on the
`
`understanding of a POSA under Medivis’s definition or any other. Instead,
`
`Novarad argued that its declarants need not qualify as a POSA and that, despite
`
`their apparently not qualifying as a POSA, they are somehow qualified “to help the
`
`Board here.” Sur-reply, 3-4.
`
`III. STANDARD FOR ADMISSION OF EXPERT OPINION
`
`There is no presumption that any proffered expert opinion is admissible. On
`
`the contrary, when the admissibility of expert testimony is specifically questioned,
`
`a proponent seeking to rely on an expert opinion must demonstrate that it satisfies
`
`ME1 47194821v.2
`
`7
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`Rule 702’s four conditions for admission. Committee Notes to 2023 Clarifying
`
`Amendment to Rule 702 (explaining that Rule 702 “has been amended to clarify
`
`and emphasize that expert testimony may not be admitted unless the proponent
`
`demonstrates to the court that it is more likely than not that the proffered testimony
`
`meets the admissibility requirements set forth in the rule”) (emphasis added).
`
`When the admissibility of an expert opinion is questioned, a proponent
`
`seeking to rely on it must demonstrate all four of the following conditions are met:
`
`(a) the expert’s scientific, technical, or other specialized knowledge will help
`
`the trier of fact to understand the evidence or to determine a fact in issue;
`
`(b) the testimony is based on sufficient facts or data;
`
`(c) the testimony is the product of reliable principles and methods; and
`
`(d) the expert’s opinion reflects a reliable application of the principles and
`
`methods to the facts of the case.
`
`Fed. R. Evidence 702 (clarifying amendment adopted by order of the Supreme
`
`Court on April 24, 2023, and effective December 1, 2023).
`
`Additionally, “to be qualified to offer expert testimony on issues from the
`
`vantage point of an ordinarily skilled artisan in a patent case, an expert must at a
`
`minimum possess ordinary skill in the art.” Kyocera Senco Industrial Tools Inc. v.
`
`International Trade Commission, 22 F.4th 1369, 1377-78 (Fed. Cir. 2022) (holding
`
`that the ITC ALJ’s admission of “testimony on any issue that is analyzed through
`
`the lens of [a POSA]” by a declarant lacking a qualification required by the
`
`ME1 47194821v.2
`
`8
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`definition of a POSA was an abuse of discretion); see also Sundance, Inc. v.
`
`DeMonte Fabricating Ltd., 550 F.3d 1356, 1363 (Fed. Cir. 2008) (holding that
`
`admission of opinion testimony was an abuse of discretion because “where an
`
`issue calls for consideration of evidence from the perspective of [a POSA], it is
`
`contradictory to Rule 702 to allow a witness to testify on the issue who is not
`
`qualified as a technical expert in that art.”). “Without that skill, the witness’
`
`opinions are neither relevant nor reliable.” Kyocera, 22 F.4th at 1377.
`
`The Board must decide any preliminary question as to a proffered expert’s
`
`qualification and as to a proffered opinion’s admissibility. Fed. R. Evidence
`
`104(a); see also Committee Notes (“Rule 104(a)’s requirement applies to expert
`
`opinions under Rule 702.”); 37 CFR § 42.62(a), (c). Even in a forum without a
`
`jury, as here, it is abuse of discretion to admit opinions on the perspective of a
`
`POSA by a declarant lacking any POSA qualification. Kyocera, 22 F.4th at 1377.
`
`IV. NOVARAD WAIVED THE RIGHT TO DISPUTE MEDIVIS’S
`DEFINITION OF A POSA
`
`In its petition, Medivis defined a POSA as having three qualifications. Pet.
`
`10. Novarad failed to challenge Medivis’s POSA definition in either its response
`
`or its sur-reply. See p. 2 supra. Medivis’s POSA definition thus stands undisputed.
`
`Novarad waived the right to dispute Medivis’s definition of a POSA in this IPR.
`
`Scheduling Order, Paper No. 8, 8 (April 24, 2023) (cautioning Novarad that “any
`
`arguments not raised in the response may be deemed waived”); see also In re
`
`ME1 47194821v.2
`
`9
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`Nuvasive, Inc., 842 F.3d 1376, 1380-81 (Fed. Cir. 2016) (patent owner
`
`participating in an IPR waives arguments by failing to pursue them).
`
`V. MULUMUDI’S OPINIONS DO NOT QUALIFY FOR ADMISSION
`
`A. Mulumudi Opinions on the Perspective of a POSA Are
`Inadmissible Because He Lacks the Required Qualifications
`
`As detailed in the Statement of Facts on pages 3-4, Mulumudi purported to
`
`opine from the perspective of a POSA. But Mulumudi does not have all of the
`
`qualifications required under the undisputed definition of a POSA. Mulumudi
`
`does not qualify as a POSA at least because (1) his medical degree is not the
`
`required degree in computer science, electrical engineering, or a related field and
`
`(2) he lacks the required years of AR device experience. Mulumudi further lacks
`
`any familiarity with the Amira and 3D Slicer visualization technology existent at
`
`the relevant time beyond the descriptions in petition exhibits. See pages 6-7 supra.
`
`Indeed, Mulumudi only claimed to be “qualified to provide expert opinions on
`
`some aspects of the technology described in the ‘271 Patent.” Ex. 2002 ¶ 29
`
`(emphasis added). Mulumudi’s opinions are inadmissible because he does not
`
`qualify as a POSA in this IPR, and Novarad never argued that he does so qualify.
`
`See, e.g., Kyocera, 22 F.4th at 1377 (“Without that skill, the witness’ opinions are
`
`neither relevant nor reliable”).
`
`B. Mulumudi’s Opinions Are Not Otherwise Qualified for Admission
`
`Contrary to the admissibility standards explained above, Novarad argued
`
`ME1 47194821v.2
`
`10
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`that, although he purported to opine on the perspective of a POSA, Mulumudi need
`
`not qualify as a POSA. Sur-reply, 3. Novarad instead argued, without qualifying
`
`him as a POSA under the undisputed definition, that Mulumudi is qualified “to
`
`help the Board here.” Sur-reply, 3-4. Merely being able to help does not satisfy
`
`the standard for admission, however. Mulumudi’s opinions are not admissible
`
`because they do not reflect a reliable application of reliable principles to
`
`sufficiently disclosed facts and so do not satisfy Rule 702’s other requirements.
`
`C. Mulumudi Relies on His Own Say-So
`
`As explained in the Statement of Facts on page 3, Mulumudi presented an
`
`overview to introduce “direct volume rendering” (DVR)—a term used nowhere in
`
`the ‘271 Patent—and its allegedly distinguishing characteristics. The overview
`
`cited no support for Mulumudi’s allegations about DVR or anything else.
`
`Thereafter, Mulumudi relied on his own unsupported overview to support his other
`
`opinions. For example, Mulumudi opined that the claimed “‘virtual 3D shape’ is
`
`derived from direct volume rendering” (Exhibit 2002, ¶ 78) but failed to point to
`
`any support in the ‘271 Patent. Even an expert may not rely on his or her own say-
`
`so but rather must support an opinion with underlying facts. Kumho Tire Co., Ltd.
`
`v. Carmichael, 526 U.S. 137, 157 (1999) (opinions “connected to existing data
`
`only by the ipse dixit of the expert” need not be admitted).
`
`D. Mulumudi’s DVR-Related Opinions Are Unreliable
`
`ME1 47194821v.2
`
`11
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`As explained in the Statement of Facts on pages 3-4, even though “direct
`
`volume rendering” appears nowhere in the ‘271 Patent, Mulumudi opined that “[a
`
`POSA] understands that the ‘271 Patent describes direct volume rendered 3D
`
`data ….” Ex. 2002, ¶ 60 (emphasis added). But when shown at his deposition the
`
`Amira reference, which uses the words “direct volume rendering” and includes
`
`exemplary figures (see Ex. 1005 at, e.g., 6/18-7/19, 37/49-39/51), Mulumudi
`
`admitted that he could identify DVR only by the words “direct volume rendering.”
`
`Exhibit 1022, 129:17-130:1. Given his admission that he can identify “direct
`
`volume rendering” only through those exact words, Mulumudi could not reliably
`
`opine that the ‘271 Patent requires DVR when that patent does not include the
`
`words “direct volume rendering.”
`
`VI. ROSENBERG’S OPINIONS DO NOT QUALIFY FOR ADMISSION
`
`A. Rosenberg’s Opinions on the Perspective of a POSA Are
`Inadmissible Because He Lacks the Required Qualifications
`
`As detailed in the Statement of Facts on pages 4-5, Rosenberg purported to
`
`opine from the perspective of a POSA. But Rosenberg does not qualify as a POSA
`
`under the undisputed definition because (1) his degrees are not in computer science,
`
`electrical engineering, or a related field; (2) he lacks the required AR device
`
`experience; and (3) he lacks both (a) familiarity with conventional medical
`
`imaging data and its visualization and (b) the benefit of working with a teammate
`
`having such familiarity. Indeed, Rosenberg admitted he is “not an expert in the
`
`ME1 47194821v.2
`
`12
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`specifics of medical imaging.” Ex. 2004 ¶ 79. Rosenberg claimed only to be
`
`“qualified to provide expert opinions on some aspects of the technology described
`
`in the ‘271 Patent ….” Ex. 2002 ¶ 38 (emphasis added). Rosenberg’s opinions are
`
`inadmissible because he does not qualify as a POSA, and Novarad never argued
`
`that he does qualify as a POSA. See, e.g., Kyocera, 22 F. 4th at 1376-77.
`
`B. Rosenberg’s Opinions Are Not Otherwise Qualified for Admission
`
`Contrary to Novarad’s argument that Rosenberg need not qualify as a POSA
`
`but can still “help the Board here,” (Sur-reply, 3-4), Rosenberg must qualify as a
`
`POSA. Kyocera, 22 F.4th at 1376-77. Further, Rosenberg’s proffered opinions are
`
`also not admissible because they are not based on specialized knowledge and they
`
`do not reflect a reliable application of reliable principles to sufficient disclosed
`
`facts and so do not satisfy Rule 702’s other requirements. See Section III supra.
`
`C. Rosenberg Opined Without Relevant Specialized Knowledge
`
`As detailed in the Statement of Facts on page 5, Rosenberg presented an
`
`overview focused on surgical applications with no specialized knowledge about
`
`surgical applications. He is not a surgeon. Rosenberg cited no support for his
`
`overview but relied on it for the remainder of his declaration.
`
`Despite admitting he is “not an expert in the specifics of medical imaging”
`
`(Ex. 2004, ¶ 79 (emphasis added)), Rosenberg construed the claim terms “three-
`
`dimensional (3D) data” and “inner layer of the patient” as requiring specific
`
`ME1 47194821v.2
`
`13
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`medical imaging. Ex. 2004, §VI.5. Opinions not based on specialized knowledge
`
`are not admissible. Sundance, 550 F.3d at 1364-1365.
`
`D. Cognitive Bias Explains How Rosenberg Found a New User
`Interface Requirement in a Non-Existent Claim Term
`
`There is a well-known adage that, to a hammer, everything looks like a nail.
`
`It means that people have a cognitive bias in favor of seeing what they know. C.f.
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1318 (Fed. Cir. 2005) (“bias can be
`
`exacerbated if the expert is not [a POSA]”). Rosenberg claimed to be “an expert in
`
`user interface design in augmented reality (AR) environments” and then
`
`“comment[ed] on the interpretation of claim terms related to that expertise.”
`
`Exhibit 2004, ¶ 78. Rosenberg’s commentary included construction of a non-
`
`existent claim term.
`
`Although Claim 1 recites a projected inner layer “being confined within a
`
`volume of a virtual 3D shape” (Ex. 1001, 18:63-65 (emphasis added)), Rosenberg
`
`opined that “a [POSA] would understand ‘being confined within a virtual 3D
`
`shape’ means that the virtual 3D shape is a ‘virtual control’ ….” Exhibit 2004, ¶ 90.
`
`Like Mulumudi, Rosenberg omitted “a volume of” from the actual claim term.
`
`Like Mulumudi, Rosenberg did not review his declaration carefully enough to
`
`recognize that he had construed a term that appears nowhere in the challenged
`
`claims. See, e.g., Exhibit 2004, §VI.3 (title and table); ¶ 90; §VI.5 (table).
`
`Rosenberg’s opinion that a non-existent claim term somehow requires a new user
`
`ME1 47194821v.2
`
`14
`
`
`
`Patent No. 11,004,271
`
`
`
`
`Attorney Docket No. 127971-00012
`
`interface should surprise no one. Rosenberg’s opinions are unreliable in view of
`
`his cognitive bias in favor of finding a new user interface and his failure to
`
`recognize that he had repeatedly mistaken the actual claim wording.
`
`VII. NOVARAD FAILED TO DISCLOSE THE BASIS FOR ITS
`PROFFERED OPINIONS
`
`Under Rule 42.65(a), expert testimony is entitled to little or no weight
`
`unless it discloses the factual basis for the opinion. See also In re Am. Acad. of Sci.
`
`Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to …
`
`conclude that the lack of factual corroboration warrants discounting the opinions
`
`expressed in the declarations.”). Although the proffered opinions purport to be on
`
`the perspective of a POSA, Novarad failed to disclose how each declarant defined
`
`a POSA in forming opinions. Each of Novarad’s declarants similarly presented an
`
`overview without any support, and then relied on it throughout the remainder of his
`
`declaration. See pages 3-5 supra. The proffered opinions should be given no
`
`weight because Novarad failed to disclose the basis for those opinions.
`
`VIII. CONCLUSION
`
`For the reasons presented above, the Board should exclude Novarad’s
`
`proffered declarations (Exhibit 2002 and 2004). As such, Novarad arguments
`
`relying on a proffered declaration should be treated as unsupported attorney
`
`argument. If the Board admits either declaration, it should be given no weight.
`
`Any material facts not specifically deni