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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
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`US Patent No. 11,004,271
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`Inter Partes Review No. IPR2023-00042
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`_______________
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`Request for Rehearing Under 37 CFR §42.71(d)(2)
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`ME1 48062993v.1
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`Patent No. 11,004,271
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`Attorney Docket No. 127971-00012
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`INTRODUCTION
`The Final Written Decision (FWD) in this IPR overlooked or misapprehended
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`matters related to the evidence of public accessibility of certain non-patent
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`references. When properly considered in view of the totality of facts and
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`circumstances in the record about their public accessibility, Chen (Exhibit 1009)1,
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`3D-Slicer-Visualization (Exhibit 1007)2, and 3D-Slicer-GUI (Exhibit 1010)3 each
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`qualify as printed publications.
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`BACKGROUND
`This IPR began when Medivis petitioned for inter partes review of US Patent
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`11,004,271 on three grounds. Novarad, the owner of the ‘271 patent, filed no
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`preliminary response. The Board instituted review on all three grounds and
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`acknowledged that, among other grounds, “[Medivis] contends that claims 1-6 and
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`1 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”).
`2 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”)
`(Ex. 1007).
`3 Main Application GUI for 3D Slicer available at https://www.slicer.org/wiki/
`Documentation/4.6/Slicer/Application/MainApplicationGUI (“last edited 7
`November 2016”) (“3D-Slicer-GUI,” aka “3D Slicer”) (Ex. 1010).
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`Patent No. 11,004,271
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`11-20 would have been obvious over the combined teachings of Doo and Amira, and
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`Attorney Docket No. 127971-00012
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`the combined teachings of Chen, [3D-Slicer-GUI], and [3D-Slicer-Visualization].”
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`Inst. Dec. 12 (citing Pet. 41-69 and Ex. 1012 ¶¶80-133).
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`In response to Novarad objections, Medivis timely served declarations and
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`other evidence as an offer of further proof of the public accessibility of its non-patent
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`references. Reply, Table of Exhibits (reporting service of Exhibits 1015-1021 and
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`1023-1024 on May 22, 2023)). With that proof in hand, Novarad nonetheless
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`asserted that Medivis “offers no proof that any of the asserted documents were in
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`fact publicly available before the priority date of the ‘271 patent.” POR 19 (July 18,
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`2023). Implicitly acknowledging the lack of candor in its absolute assertion,
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`Novarad argued “a copyright notice ... is not enough.” POR 19-20.
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`As to obviousness of ‘271 patent claims in view of the combined teachings of
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`Chen, 3D-Slicer-Visualization, and 3D-Slicer-GUI, the FWD “start[ed] and end[ed
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`the] analysis with public accessibility.” FWD 26. It found that, “[b]ecause
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`[Medivis] has not shown any of the references of this ground to be publicly
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`accessible prior art, Petitioner has not proven by a preponderance of evidence that
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`claims 1-6 and 11-20 would have been obvious over the combination of Chen, [3D-
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`Slicer-Visualization], and [3D-Slicer-GUI].” FWD 31.
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`STANDARD FOR EVALUATION
`“‘[P]ublic accessibility’ [is] the touchstone in determining whether a reference
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`constitutes a ‘printed publication’ bar under 35 U.S.C. § 102(b).” Hulu, LLC v.
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`Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019)
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`(precedential) at 10 (quoting Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331,
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`1348 (Fed. Cir. 2016)). “A given reference is ‘publicly accessible’ upon a
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`satisfactory showing that such document has been disseminated or otherwise made
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`available to the extent that persons interested and ordinarily skilled in the subject
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`matter or art exercising reasonable diligence, can locate it.” Hulu, at 10-11 (quoting
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`SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008)).
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`“What constitutes a ‘printed publication’ must be determined in light of the
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`technology employed.” Hulu, at 10 (citing Samsung Elecs. Co. v. Infobridge Pte.
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`Ltd., 929 F.3d 1363, 1369 (Fed. Cir. 2019)).
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`Nonetheless, “the indicia on the face of a reference, such as printed dates and
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`stamps, are considered part of the totality of the evidence.” Hulu, at 17-18 (citing
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`Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1377 (Fed. Cir.
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`2018)). Applying the law to the facts of record, the Hulu decision—which is
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`precedential as to how a petitioner may show an asserted reference qualifies as a
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`printed publication—held that a copyright date, a printing date, an ISBN date, and
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`Patent No. 11,004,271
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`an established publisher of a series of a similar type of references demonstrate a
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`reasonable likelihood that a book is a printed publication. Hulu, at 19-20.
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`OVERLOOKED AND MISAPPREHENDED MATTERS
`The FWD did not properly evaluate the public accessibility of Chen (Exhibit
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`1009), 3D Slicer-Visualization (Exhibit 1007) and 3D Slicer-GUI (Exhibit 1010) in
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`view of all of the facts and circumstances relevant to their public accessibility of
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`record with respect to the Petition, the Reply, Novarad’s adopted evidence, and
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`undisputed facts set forth in Medivis’s Motion to Exclude.
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`First, the FWD wrongly found that the Petition offers “no proof” that any of
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`these references were publicly accessible. FWD 26 (citing Pet. 29-30). The FWD’s
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`citation suggests that finding is based on only two pages of the Petition. But even
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`those two Petition pages cite evidence that the Hulu tribunal recognized as a type of
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`evidence that can support a finding that a reference is a printed publication:
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`including a copyright date, a publication date, and an established publisher of a series
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`of a similar type of references. Hulu, at 19-20. The Board overlooked or
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`misapprehended the substance of Hulu’s precedential decision and how that decision
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`applies to the Petition evidence including, but not limited to, evidence cited on pages
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`29-30 of the Petition.
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`Professor Kazanzides qualifies as a person of ordinary skill in the art (POSA),
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`under both his proposed definition and the Board’s slightly-modified definition. Pet.
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`9-10; FWD 7. The Petition relies on Kazanzides’s knowledge and experience from
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`“teaching, researching, and working in the field of computer-assisted surgery for
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`nearly 20 years,” as presented in his original declaration. Pet. 9-10 (citing Ex. 1012).
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`The Petition explained that, “by 2014, the 3D Slicer open-source software
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`platform for segmentation, registration, and 3D visualization of medical imaging
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`data was on its fourth major revision.” Pet. 16-17 (citing Ex. 1012 ¶41 and Ex. 1007,
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`slides 6-7). The www.slicer.org website was known as the source for information
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`about the “well-known free and open-sourced package named 3D Slicer.” Pet. 54
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`(citing Ex. 1009, 131 at 1:29-31). Based on his knowledge and experience as an
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`expert qualified as a POSA, Kazanzides testified that “[a] POSA would have been
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`familiar with the 3D Slicer application and its ability to load and display data for a
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`user.” Pet. 16-17 (citing Ex. 1012 ¶41).
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`Based on his knowledge and experience, Kazanzides further testified that, “in
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`2014, the Surgical Planning Laboratory (‘SPL’) published examples of 3D data
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`displayed as individual 2D slices of inner layers of a patient’s anatomy.” Pet. 17-18
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`(citing Ex. 1012 ¶42 (citing Ex. 1007, slide 39)). Similarly, based on his knowledge
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`and experience, Kazanzides testified that, “in 2014, the SPL published examples of
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`3D data displayed as a 3D model of inner layers of a patient’s anatomy.” Pet. 18-19
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`(citing Ex. 1012 ¶43 (citing Ex. 1007, slide 42)).
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`Based on his knowledge and experience, Kazanzides also testified that, “[b]y
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`2016, the 3D Slicer software included published documentation of the Main
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`Application Graphical User Interface (GUI).” Pet. 55 (citing Ex. 1012 ¶106 (citing
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`Ex. 1010)). The Board overlooked or misapprehended Kazanzides’s original
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`testimony cited in the Petition as to the public accessibility of non-patent references
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`related to 3D Slicer.
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`In considering Chen (Exhibit 1009), the FWD overlooked or misapprehended
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`the substance of the Hulu decision as it pertains to Petition evidence of its public
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`accessibility. The FWD indicates that Medivis cannot rely “in part on the face of
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`Chen.” FWD 28 (explaining “any reference can state that it was published without
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`actually being published”). Similarly, the FWD improperly rejected as evidence of
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`public accessibility the fact that Chen “was published in volume 55 of the
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`JOURNAL OF BIOMEDICAL INFORMATICS.” Pet. 29-30 (citing Ex. 1009 at
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`124-131). But the FWD’s approach directly contradicts Hulu’s explanation that “the
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`indicia on the face of a reference, such as printed dates and stamps, are considered
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`part of the totality of the evidence.” Hulu, at 17-18. The Board should reconsider
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`the totality of the evidence as to Chen’s public accessibility with the understanding
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`from Hulu that indicia on its face are part of the totality of evidence.
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`Second, the Board overlooked or misapprehended most of the relevant
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`evidence presented in the Reply.4 The FWD acknowledges that 3D Slicer-GUI
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`(Exhibit 1010) is “documentation for Slicer software[, which] describes an
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`application menu, toolbar, data probe, 3D viewer, slice viewers, and chart viewers.”
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`FWD 26. But finding it somehow unduly burdensome, the Board overlooked
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`Kazanzides’s cited testimony that 3D Slicer-GUI (Exhibit 1010) is documentation
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`for Version 4.6 of 3D Slicer, which was released on November 8, 2016. Reply 28
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`(citing Ex. 1021 ¶¶ 36-38). The Board also either misapprehended or overlooked
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`the logic that application documentation must be accessible to potential application
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`users because it serves to help users use the application.
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`The FWD acknowledges that 3D Slicer-Visualization (Exhibit 1007) is a
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`“tutorial [that] provides an introduction to the 3D Slicer software, describes 3D data
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`loading and visualization of images, and describes 3D interactive exploration of the
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`anatomy.” FWD 25. But finding Kazanzides’s five short cited paragraphs somehow
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`unduly burdensome, the Board overlooked the cited support for the statement that
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`4 The Board expressed its willingness to consider uncited exhibits, filed
`without explanation, for Novarad’s benefit. Order, Paper 23 (Dec. 11, 2023), 4
`(“At a minimum, we are able to assess the qualifications of [Novarad’s] declarants
`based on their [uncited] curricula vitae.”)). It would be arbitrary and capricious for
`the Board to not be at least as willing to review cited exhibits of similar length for
`Medivis’s benefit.
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`3D Slicer-Visualization (Exhibit 1007) “was available on the internet on September
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`Attorney Docket No. 127971-00012
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`30, 2014.” Reply 27-28 (citing Ex. 1007, 2-124; Ex. 1019; Ex. 1021, ¶¶ 25-29).
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`Although Hulu found that an established publisher of a series of a similar type of
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`references to be evidence that a reference is publicly accessible (Hulu at 19-20)—
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`the FWD found to the contrary that the fact that 3D Slicer’s Director of Training had
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`presented similar tutorials at 22 conferences to more than 2700 people (Reply 27-28
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`(citing Ex. 1007, 1-2, 7-8, 14-15, and Ex. 1021 ¶¶11-23)) does not support the public
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`accessibility of 3D Slicer-Visualization (Exhibit 1007) (FWD 29).
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`Third, the Board overlooked Novarad’s adoption of the Price Declaration as
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`its own evidence of the state of the art at the relevant time. Novarad cited the Price
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`Declaration as evidence of the state of the art at the relevant time. Sur-reply 20-21
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`(citing the Price Declaration as Ex. 1023). Requesting authorization to file the Price
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`Declaration later, Novarad represented that it had intended to file the Price
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`Declaration with its Sur-reply. Order, Paper 23 (Dec. 11, 2023) (hereinafter
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`“December Order”), 2 (citing “Ex. 3001” (not included in record)). Although the
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`Board later expunged it as duplicative of Medivis Exhibit 1023, on December 12,
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`2023, Novarad did file a copy of the Price Declaration as Novarad Exhibit 2023.
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`Novarad’s designation of the Price Declaration as Exhibit 2023 confirms that
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`Novarad adopted the Price Declaration as its own evidence of the state of the art. See
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`37 CFR §42.63(c) (“the patent owner[’s exhibit] range is 2001-2999.”).
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`The Board overlooked the fact that the Price Declaration addresses the public
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`accessibility of two petition exhibits: Amira 5 User’s Guide (Exhibit 1005) and 3D
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`Slicer-Visualization (Exhibit 1007). Although the Price Declaration includes
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`complete copies of both Petition exhibits, Novarad need not have adopted the Price
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`Declaration as its own evidence to be able to reference a complete copy of the Amira
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`5 User’s Guide (Exhibit 1005). For example, the Frank-White Declaration (Exhibit
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`1024), which was equally available to Novarad, includes a complete copy of the
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`Amira 5 User’s Guide (Exhibit 1005) but does not reference 3D Slicer-Visualization
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`(Exhibit 1007). By adopting the Price Declaration as its own evidence of the state
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`of the art, Novarad waived the right to challenge the Price Declaration and added to
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`the record evidence of the public accessibility of 3D Slicer-Visualization (Exhibit
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`1007). Medivis cannot be faulted for not explaining the Price Declaration as
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`evidence of 3D Slicer-Visualization’s public accessibility because the Board denied
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`Medivis’s request for additional briefing in view of Novarad’s citation of previously-
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`uncited new evidence in its Sur-reply. December Order 4.
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`Fourth, the Board overlooked undisputed facts in Medivis’s Motion to
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`Exclude (MTE). Rule 42.23(a) requires that any opposition to a motion that
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`contains a statement of material facts (SOMF) include “a listing of facts that are
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`admitted, denied, or cannot be admitted or denied” and provides that “[a]ny material
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`fact not specifically denied may be considered admitted.” Medivis included a SOMF
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`in its MTE and specifically requested that “[a]ny material facts not specifically
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`Attorney Docket No. 127971-00012
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`denied ... be deemed admitted.” MTE 2-7, 15. Medivis’s SOMF should be
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`considered admitted because Novarad neither denied nor otherwise responded to any
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`fact presented therein. See generally Opp. to MTE.
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`As explained in Medivis’s SOMF, Novarad’s expert admitted that multiple
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`research groups commonly used 3D Slicer technology before the relevant time:
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`Mulumudi admitted that he was unfamiliar with 3D Slicer visualization
`technology (Ex. 1022, 130:6-8, 131:3-6, 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.
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`MTE SOMF 6-7. The public availability of the 3D Slicer related references should
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`be reconsidered in view of that undisputed fact and the inference that groups
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`commonly using 3D Slicer technology before the relevant time must have had some
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`way to understand the 3D Slicer technology and to learn how to use it.
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`CONCLUSION
`Medivis respectfully requests that the Board reconsider the public availability
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`of Chen (Exhibit 1009), 3D Slicer-GUI (Exhibit 1010), and 3D Slicer-Visualization
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`Patent No. 11,004,271
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`(Exhibit 1007) based on the overlooked or misapprehended matters identified above.
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`Attorney Docket No. 127971-00012
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`Based on the totality of facts and circumstances of record, including those that were
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`misapprehended or overlooked, the Board should find that Chen (Exhibit 1009) is
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`an article that was publicly accessible from the Journal of Biomedical Informatics
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`and ScienceDirect before the relevant date. Based on the totality of facts and
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`circumstances of record, including those that were misapprehended or overlooked,
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`the Board should find that 3D Slicer-GUI (Exhibit 1010) was documentation of a
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`version of 3D Slicer publicly accessible to potential 3D Slicer users on the
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`www.slicer.org website before the relevant date to aid in their understanding of the
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`main graphical user interface (GUI) for that version of 3D Slicer. Similarly, based
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`on the totality of facts and circumstances of record, including those that were
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`misapprehended or overlooked, the Board should find that 3D Slicer-Visualization
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`(Exhibit 1007) was a tutorial by 3D Slicer’s Director of Training publicly accessible
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`to potential 3D Slicer users on the www.slicer.org website before the relevant date
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`to help them use 3D Slicer.
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`Respectfully submitted,
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`April 5, 2024
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`ME1 48062993v.1
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`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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`Patent No. 11,004,271
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`Attorney Docket No. 127971-00012
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Request for
`Rehearing was served on April 5, 2024 by transmitting a copy by e-mail to the
`email addresses of the patent owner’s attorneys of record in the patent owner’s
`latest mandatory notice:
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`joseph.harmer@tnw.com; and
`hansen@tnw.com
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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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