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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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`VISIONSENSE CORP.
`Petitioner,
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`v.
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`NOVADAQ TECHNOLOGIES INC.
`Patent Owner.
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`Patent No. 8,892,190
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`_______________
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`Inter Partes Review No. IPR2017-01426
`____________________________________________________________
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`DECLARATION OF BRIAN WILSON
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`I. PROFESSIONAL BACKGROUND .................................................................. 3
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`TABLE OF CONTENTS
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`II.
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`BASIS FOR OPINION .................................................................................... 5
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`III.
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`Little ................................................................................................................. 6
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`IV. CONCLUSION ..............................................................................................12
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`I, Brian Wilson, Ph.D., declare as follows:
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`1.
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`I have been retained as an expert on behalf of Novadaq Technologies
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`Inc., in the above-captioned Inter Partes Review of U.S. Patent No. 8,892,190
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`(“the ’190 patent”). I have been asked to provide my opinions and views on the
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`Little prior art (Ex. 1002) cited in the Petition for Inter Partes Review of the ’190
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`Patent filed by Visionsense Corp.
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`I.
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`PROFESSIONAL BACKGROUND
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`2.
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`I am a medical biophysicist with more than 40 years of experience in
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`the field.
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`3.
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`I obtained a Ph.D. in experimental physics from the University of
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`Glasgow in 1971.
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`4. My professional experience has included three years at the Institute of
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`Cancer Research at the Royal Marsden Hospital in the United Kingdom, from 1972
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`to 1974, engaged in the study of radiological physics, imaging and therapeutics. I
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`subsequently spent seven years as a medical physicist, including five years as
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`Assistant Professor of Diagnostic Radiology at Flinders University Medical Center
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`in Australia, from 1974 to 1981. I then became the Head of Medical Physics at the
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`Hamilton Cancer Centre at McMaster University in Hamilton, Ontario, Canada,
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`first as an Associate Professor and then as a Full Professor, from 1981 to 1993. In
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`my capacity at McMaster University, I established a research program in
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`Biomedical Optics, including Optical Imaging and Therapeutics.
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`5.
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`I am currently a Senior Scientist at University Health Network and
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`Professor of Medical Biophysics in the Faculty of Medicine at University of
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`Toronto in Toronto, Canada. I have been in this position since 1993. I lead a
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`translational research program in the application of optics-based techniques to
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`human imaging and treatment. I also co-direct the Advanced Optical Microscopy
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`Facility at the University Health Network, which is an association of several major
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`teaching hospitals of the University of Toronto, along with their associated
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`research institutes.
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`6.
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`I have published more than 370 peer-reviewed scientific papers, of
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`which more than 300 are in the area of biomedical optics and its applications.
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`7.
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`Biomedical optics is defined as the use of light and optical
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`technologies for applications in the life sciences and clinical medicine. This
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`includes optical imaging, image-guided therapeutics and light-based treatments,
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`including the use of lasers.
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`8.
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`I have extensive experience in fluorescence imaging in a wide variety
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`of applications. Examples include the use of high-resolution fluorescence
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`microscopy for cellular imaging and for imaging tissue vasculature and tissue
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`function, the use of fluorescent nanoparticles and other fluorescence agents for
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`tissue contrast, the use of fluorescence endoscopy using autofluorescence of tissues
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`and fluorescent dyes for cancer imaging, and the design and construction of
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`fluorescence imaging systems for intraoperative use in guiding surgery.
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`9. My professional work has involved the development of wide field of
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`view fluorescence imaging systems for intraoperative use in guiding brain surgery.
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`10.
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`I am being compensated at an hourly rate by the Patent Owner for my
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`assistance in connection with the above-captioned inter partes review proceeding,
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`and all activities in connection with the preparation of this declaration. I am being
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`paid regardless of the conclusions or opinions I reach. I have no personal financial
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`stake or interest in the outcome of the present inter partes review.
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`II. BASIS FOR OPINION
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`11. My opinions and views set forth in this report are based on my
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`education, training, and experience in the relevant field, as well as the materials I
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`reviewed in this case, and the scientific knowledge regarding the same subject
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`matter that existed prior to the earliest effective filing date of the ’190 patent.
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`III. LITTLE1
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`12. Little discloses performing fluorescein dye based angiography during
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`bypass surgery on the brain to assess the success of a superficial temporal artery
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`(STA) to middle cerebral artery (MCA) anastomosis. (Ex. 1002 at 560.)
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`13. Little describes the anastomosis procedure as follows:
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`An inverted U-shaped scalp flap was turned. The larger STA
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`branch, together with a generous cuff of connective tissue, was
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`mobilized carefully. A relatively large temporoparietal
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`craniotomy was performed. The largest exposed cortical artery,
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`usually the angular branch of the MCA, was selected as the
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`receptor vessel. Mean STA diameter was 1.3 mm (range: 0.9 to
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`1.6 mm) and mean receptor artery diameter was 1.2 mm (range:
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`0.9 to 1.6- mm). Continuous suturing11 was performed for the
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`anastomosis in all but the initial three patients, in whom the
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`standard interrupted suture technique was used. The operations
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`were carried out by one surgeon (J.R.L.).
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`(Id. at 562.) Based on the operative procedure described in Little, the MCA was
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`thus selected as the receptor vessel and the STA was selected as the vessel graft
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`1 The copy of Little provided by the Petitioner as Exhibit 1002 includes poor
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`quality images. Accordingly, Patent Owner provided me a copy of Little scanned
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`at higher resolution but otherwise identical. The images of Little reproduced
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`within are from the higher resolution copy, which is cited as Ex. 2001.
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`(i.e., the vessel that is implanted into the subject). The STA was anastomosed to
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`the MCA to bypass blockage in the upstream internal carotid artery or upstream
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`portion of the MCA. (Id. at 560.)
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`14. Little provides a white-light image of a surgical site after anastomosis
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`of the STA vessel graft to the MCA receptor vessel in the upper left image of
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`Figure 1. (Id. at 563.) The caption of Figure 1 explains that in this image, the STA
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`is covered by “a generous cuff of connective tissue and fat (X).” (Id.) The upper
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`left image of Figure 1 is provided below with annotations.
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`(Ex. 2001 at Figure 1 (annotation added).) The above annotation of this image
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`outlines the cuff of connective tissue and fat to help illustrate the location of the
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`STA, which as explained in Little, is covered by the cuff of connective tissue and
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`fat. That portion of the image was marked with an “X” in Little itself. The STA
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`vessel graft is not visible in this image due to the covering of connective tissue and
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`fat. The same is true of the white-light images in Figures 2 through 4.
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`15. Little describes that fluorescence imaging was performed to assess the
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`success of the anastomosis procedure. (Ex. 1002 at 564.) The remaining five
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`images in Figure 1 are fluorescence images showing the movement of fluorescent
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`dye through the vessel to which the vessel graft is attached and downstream
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`vasculature. (Ex. 1002 at Figure 1 caption.)
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`16. The top right image of Figure 1, bearing the time stamp of 01:13
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`provides an example of the lack of fluorescence response in the area of the STA
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`vessel graft. This image is reproduced below.
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`(Ex. 2001 at Figure 1 (annotated).) The caption of Figure 1 explains that the white
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`area (indicated by the arrow in the above annotation) illustrates “filling of the
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`cortical receptor artery.” (Ex. 1002 at Figure 1 caption.)
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`17. As explained by Little in the description of the operative procedure,
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`the “largest exposed cortical artery, usually the angular branch of the MCA, was
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`selected as the receptor vessel.” (Ex. 1002 at 562 (emphasis added.) Therefore,
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`the “cortical receptor artery” mentioned in the caption of Figure 1 is the MCA.
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`Thus, one of ordinary skill in the art would understand that the portion of the upper
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`right image of Figure 1 of Little (reproduced above) shows fluorescence response
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`of the blood flow in the MCA receptor vessel.
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`18. Because of the covering by the cuff of connective tissue and fat, the
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`STA vessel graft is not shown in the upper right image of Figure 1 of Little. The
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`central portion of the image—the location of the cuff of connective tissue and fat
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`covering the STA vessel graft—is completely dark.
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`19.
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`In the other four fluorescence images of Figure 1 of Little,
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`fluorescence radiation in the MCA receptor vessel and downstream vessels is
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`captured, but blood flow within the STA vessel graft is completely obscured by the
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`cuff of connective tissue and fat. (Id.) The lower central portion of each image—
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`the location of the cuff covering the STA—is completely dark.
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`20. The center right image of Figure 1 of Little provides a stark example
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`of the lack of fluorescence response in the area of the STA vessel graft. The below
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`annotation of the center right image of Figure 1 includes an arrow indicating the
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`dark area in the center of the image to illustrate the lack of imaging of the STA
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`vessel graft.
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`(Ex. 2001 at Figure 1.) In the above image, fluorescence radiation emitted from
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`areas downstream of the anastomosis is captured, as indicated by the light-colored
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`areas. But, no fluorescence radiation has been captured in the area of the STA
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`vessel graft, as indicated by the darkness in the area corresponding to the cuff of
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`connective tissue and fat.
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`21. Little provides images for three other surgical procedures in Figures 2
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`through 4. Each of the procedures depicted in the figures of Little included a cuff
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`of connective tissue and fat over the STA that prevented detection of any
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`fluorescence signal from dye within the STA. (Id. at 564-66.) While the image on
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`the right in Figure 4 includes some fluorescence signal in the vicinity of the cuff,
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`the caption of Figure 4 explains that this is due to leakage of the fluorescein dye
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`into the walls of the STA and the surrounding tissue and is not radiation from dye
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`within the STA. (Ex. 1002at 566.)
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`22. Little therefore includes images that show blood flow in the MCA
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`receptor vessel to which the vessel graft is attached and in downstream vessels, but
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`none of the images shows blood flow in the STA vessel graft itself. The STA
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`vessel graft was covered with a layer of tissue and fat that prevented imaging of the
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`blood flow within the STA vessel graft.
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`IV. CONCLUSION
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`23.
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`I hereby declare that all statements made herein of my own
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`knowledge are true, and that all statements made on information and belief are
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`believed to be true, and that these statements were made with knowledge that
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`willful false statements and the like so made are punishable by fine or
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`imprisonment, or both, under 18 U.S.C. § 1001.
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`Dated: August 22, 2017
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`Brian Wilson
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`Novadaq Technologies Inc. Exhibit 2002 Page 12
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