IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`PATENT TRIAL AND APPEAL BOARD
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`CathWorks Ltd
`Petitioner
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`v.
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`HeartFlow, Inc.
`Patent Owner
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`_____________________
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`CASE: PGR2018-00006
`U.S. PATENT NO. 9,613,186
`_____________________
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`DECLARATION OF SABEE MOLLOI IN SUPPORT OF PETITION FOR
`POST-GRANT REVIEW OF U.S. PATENT 9,613,186
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`CATHWORKS EXHIBIT 1002
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`PATENT TRIAL AND APPEAL BOARD
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`CathWorks Ltd
`Petitioner
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`v.
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`HeartFlow, Inc.
`Patent Owner
`
`_____________________
`
`CASE: PGR2018-00006
`U.S. PATENT NO. 9,613,186
`_____________________
`
`
`
`DECLARATION OF SABEE MOLLOI IN SUPPORT OF PETITION FOR
`POST-GRANT REVIEW OF U.S. PATENT 9,613,186
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`I, Sabee Molloi, Ph.D., do hereby declare and say:
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`1.
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`I am over the age of twenty-one (21) and competent to make this
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`declaration. I am also qualified to give testimony under oath. The facts and
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`opinions listed below are within my personal knowledge.
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`2.
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`I am not an employee of the Petitioner in this matter. Rather, I have been
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`engaged in this matter to provide my independent analysis of certain issues I
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`understand arise in connection with the Inter Partes Review of U.S. Patent
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`No. 9,613,186 (which I refer to as the ‘186 Patent) (Ex 1001). I have
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`received no compensation for this declaration beyond my normal hourly rate
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`for time spent on this matter, and I will not receive any added compensation
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`based on the outcome of any proceeding related to the ‘186 Patent.
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`3.
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`I have been asked to review certain documents, including the ‘186 Patent
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`(Ex 1001), and to provide my opinions on how those of skill in the art (as
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`defined herein) would understand those documents. For purposes of this
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`declaration, the documents I was asked to review include:
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` U.S. Patent No. 9,613,186 (“‘186 Patent”) (Ex 1001);
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` U.S. Patent Publication No. 2014/0200867 to Ifat Lavi et al. (“Lavi”)
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`(Ex. 1005);
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` Wong J, Molloi S, “Determination of fractional flow reserve (“FFR”)
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`based on scaling laws: a simulation study,” Phys. Med. Biol.,
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`53(14):3995–4011, 2008 (“Wong 2006”) (Ex. 1006);
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` U.S. Patent Publication No. 2012/0059246 (“Taylor”) (Ex. 1008);
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` Huo, Yunglong, et al, “A validated predictive model of coronary
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`fractional flow reserve,” The Journal of The Royal Society, 1325–
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`1338, 2011 (“Huo”) (Ex. 1011);
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` Pijls et al., “Measurement of Fractional Flow Reserve to Assess the
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`Functional Severity of Coronary-Artery Stenoses,” The New England
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`Journal of Medicine, Vol. 334 No. 26, 1703–1708, June 27, 1996
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`(“Pijls”) (Ex. 1014); and
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` Cleveland Clinic, “Heart & Blood Vessels: Your Coronary Arteries,”
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`Cleveland Clinic Health Library, September 13, 2017, available at:
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`https://my.clevelandclinic.org/health/articles/heart-blood-vessels-
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`coronary-arteries (“Cleveland Clinic”) (Ex. 1016).
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`I provide my conclusions regarding the disclosures of these documents
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`below.
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`4.
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`I was asked to provide opinions about what those of skill in the art would
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`have understood is disclosed by Lavi. In this regard, I was asked to provide
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`opinions about whether or not what is claimed in the ‘186 Patent is disclosed
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`or taught by Lavi. I was also asked to provide opinions about the relevant
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`state of the art. I have offered my opinions on these issues where asked.
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`5.
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`I am not offering any conclusions as to the ultimate determinations that I
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`understand the Patent Trial and Appeal Board will make in this proceeding.
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`I am simply providing my opinion on the technical aspects of the documents
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`(including, where asked, the application of what I understand Petitioner
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`asserts is the appropriate construction of claim terms for this proceeding)
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`and on the concepts disclosed in the documents from a technical perspective.
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`BACKGROUND
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`6.
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`I hold an undergraduate degree in chemistry and physics. In addition, I hold
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`a master’s degree and Ph.D. in medical physics. I have 39 years of
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`experience in the field of medical physics and radiological sciences, with my
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`last 15 years specifically focused on the field of coronary blood flow
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`characterization.
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`7.
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`I received my Bachelor of Science degree in chemistry and physics from
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`Minnesota State University in 1980. I received my master’s degree in
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`medical physics from the University of Wisconsin in 1985. I received my
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`doctorate in Medical Physics from the University of Wisconsin in 1987.
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`8. While in undergraduate and graduate school and as a postdoctorate
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`researcher, I held various research positions in medical physics, nuclear
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`medicine, and radiological sciences.
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`9.
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`From 1989 to present, I have been a professor at the University of
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`California-Irvine in various departments, including Radiological Sciences,
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`Medicine
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`(Cardiology), Electrical and Computer Engineering, and
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`Biomedical Engineering.
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`10.
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`I am also currently the vice chairman of research of the Department of
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`Radiological Sciences at the University of California-Irvine.
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`11.
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`I am listed as an inventor on U.S. Patent No. 5,778,046, entitled “Automatic
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`x-ray beam equalizer;” U.S. Patent No. 5,881,127, entitled “Automatic x-ray
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`beam equalizer;” and U.S. Patent No. 8,447,387, entitled “Method and
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`apparatus for real-time tumor tracking by detecting annihilation gamma rays
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`from low activity position isotope fiducial markers.” I am also listed as an
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`inventor on a number of pending U.S. patent applications including U.S.
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`Patent Publication No. 2011/0280371, entitled “TiO2 Nanotube Cathode for
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`x-ray generation.”
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`12.
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`I have authored over a hundred papers regarding medical imaging and
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`analysis, including numerous papers regarding quantitative aspects of
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`analyzing fraction flow reserve of the coronary arteries. Examples of these
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`papers include:
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` Wong J, Ducote J, Xu T, Hassanein M, Molloi S, “Automated
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`technique for angiographic determination of coronary blood flow
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`and lumen volume”, Acad. Radiol. 2006 Feb;13(2):186–94;
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` Molloi S, Wong J, “Regional blood flow analysis and its
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`relationship with arterial branch lengths and lumen volume in
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`coronary arterial tree”, Phys. Med. Biol., 52:1495–1503, 2007;
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` Molloi S, Chalyan D, Le H, Wong J, “Estimation of coronary
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`hyperemic artery blood flow based on arterial lumen volume using
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`angiographic images”, Int. J. Cardiovasc. Imaging. 28:1–11, 2012;
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`and
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` Wong J, Le H, Suh W, Chalyan D, Mehraien T, Kern M, Kassab
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`G, Molloi S, “Quantification of fractional flow reserve based on
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`angiographic image data”, Int. J. Cardiovasc. Imaging. 28:13–22,
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`2012.
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`13. For these reasons and because of my technical experience and training as
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`outlined in my curriculum vitae (Ex. 1003), I believe I am qualified to offer
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`technical opinions regarding the ‘186 Patent and the other documents I have
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`reviewed as part of my work in this matter.
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`14.
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`I believe I am capable of opining about the state of the art in the field of
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`fraction flow reserve analysis of the coronary arteries at various points in
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`time from the mid 2000s to the present, as I have been familiar with the
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`academic and commercial work being done by others in the industry during
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`this time.
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`OVERVIEW OF FRACTIONAL FLOW RESERVE
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`15. Coronary artery disease is a serious condition that results in a restriction of
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`blood flow to the heart and can ultimately affect the heart’s ability to pump
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`blood to other organs. The figure below from Ex. 1016 shows a diagram
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`exemplary of a human heart.
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`(Ex. 1016). The vena cava, aorta, and pulmonary artery are vessels that
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`carry blood to or from the heart to other organs in the body. In contrast, the
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`coronary arteries (i.e., the left coronary artery and the right coronary artery)
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`carry oxygenated blood pumped from the heart to heart tissue. The coronary
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`arteries provide oxygen and nutrients that allow the heart to continuously
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`beat.
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`16. Coronary artery disease is oftentimes caused by a narrowing of one or more
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`blood vessels in the right and left coronary arteries. The narrowing is
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`referred to as a stenosis or a lesion. For illustration, the labeled figures
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`below from Ex. 1011 show representations of a healthy vessel and a
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`stenosed vessel.
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`Stenosed Vessel
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`Healthy Vessel
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`(Ex. 1011 at 1329). The healthy vessel has a substantially circular cross-
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`sectional area (“CSA”). In contrast, the stenosed vessel is compressed,
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`thereby decreasing the CSA. As one can appreciate, blood flow and
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`pressure are significantly reduced in the stenosed vessel as a result of the
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`narrowing.
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`17. One method of determining the health of a coronary artery (or the severity of
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`a stenosis) is to estimate the FFR in the coronary vessels under a hyperemic
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`condition. FFR is traditionally defined as a ratio of a maximal blood flow
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`rate in a location of an artery with a stenosis, divided by a theoretical
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`maximal flow rate at the same location without the stenosis. (Ex. 1014 at
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`1703).
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`18. FFR may also be determined without determining a theoretical maximal
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`flow rate when a stenosis is removed. Specifically, this alternative
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`measurement of FFR includes a ratio of distal to proximal pressure with
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`respect to a stenosis. The proximal pressure is measured upstream from the
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`stenosis and provides a clinically acceptable estimate of a theoretical
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`maximal flow rate of the coronary artery without stenosis.
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`19. FFR values provide clinicians with a quantitative assessment regarding the
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`need for revascularization in a patient. (Ex. 1006 at 3997). Typically, FFR
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`values less than 0.75 (and more recently 0.8) are indicative of a significant
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`stenosis of the coronary arteries. (Ex. 1014 at 1703). In other words, a
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`blood flow reduction of 20% to 25% (or pressure drop around 20% or 25%)
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`in a vessel of the coronary arteries is significant enough to warrant clinical
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`intervention. An example of intervention includes percutaneous coronary
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`intervention, more commonly known as coronary angioplasty. Under
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`percutaneous coronary intervention, a catheter tube or stent is placed into the
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`stenosis location of the coronary artery to reverse the narrowing. (Ex. 1014
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`at 1703).
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`20.
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`Initially in the 1990s, FFR primarily could only be determined invasively
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`through direct measurement. The invasive measurement includes inserting a
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`guidewire into a patient’s coronary arteries during coronary catheterization.
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`(Ex. 1014 at 1704). Measurements are recorded at proximal and distal
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`points relative to the stenosis in the coronary arteries. (Ex. 1011 at 1325;
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`Ex. 1014 at 1704). In this method, FFR is determined as a ratio of pressure
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`distal to the artery narrowing to pressure proximal to the narrowing. (Ex.
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`1011 at 1325; Ex. 1014 at 1704). The pressure at the proximal location
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`represents the theoretical pressure in the same vessel as if the stenosis or
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`narrowing were removed. (Ex 1011 at 1328).
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`21. With advances in image analysis and computing technology in the 2000s,
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`researchers and companies began searching for ways to noninvasively
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`measure the FFR in a patient’s coronary arteries. As one can imagine,
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`invasive measurements, while accurate, take a moderate amount of time to
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`perform and require that a pressure wire be placed across the stenosis. In
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`addition, invasive measurements place the patient at risk of complications
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`from the insertion of a pressure wire across the stenosis.
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`22. The noninvasive methods use medical images to estimate physical
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`dimensions or properties of a patient’s coronary arteries. The physical
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`dimensions or properties are used to estimate blood flow or pressure
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`throughout the coronary arteries. FFR may then be determined from the
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`estimated blood flow or pressure.
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`23. One noninvasive method includes constructing a computational fluid
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`dynamics (“CFD”) model of a patient’s coronary arteries from computed
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`tomography angiography images. Under this method, the myocardial mass
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`is used to estimate the expected blood flow in the coronary arteries. The
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`blood flow in conjunction with CFD is used to estimate pressure and blood
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`flow at different points in the coronary arteries. Similar to the invasive
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`method, FFR is determined as a ratio of pressure distal to the artery
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`narrowing to pressure proximal to the narrowing.
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`24. While this noninvasive method provides relatively accurate results, as long
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`as the boundary conditions are modeled correctly, the method relies on
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`complex CFD equations to estimate blood flow and pressure. In practice, it
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`can take several hours to estimate FFR once the medical images have been
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`received, and many times this determination is done offsite. Ideally,
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`clinicians desire onsite measurements done in a short period of time.
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`25. Lavi, as discussed in further detail below, discloses methods of determining
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`FFR that can be performed onsite and are potentially faster than the CFD
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`method discussed above. (See, e.g., Ex. 1005 at ¶193).
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`U.S. PATENT NO. 9,613,186
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`26.
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`I have been asked to assume (and I have assumed) for purposes of my
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`analysis that the ‘186 Patent has a priority date of March 31, 2014. I have
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`therefore tried to offer opinions in this declaration through the eyes of one of
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`skill in the art (as defined below in Paragraph 38) as of March 31, 2014.
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`27. The ‘186 Patent discloses techniques for determining FFR in the coronary
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`arteries of a patient. The majority of the specification and the figures from
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`the ‘186 Patent describe using a CFD approach to determining FFR. (See
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`Ex. 1001 at 19:13–32; 20:12–52; 30:15–64; 33:4–62). However, a small
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`section of the ‘186 Patent, as an alternative embodiment, discusses the
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`calculation of FFR using a simulated revascularization approach. (See Ex.
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`1001 at 40:63–41:33).
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`28. The ‘186 Patent discloses that the simulated revascularization approach is
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`provided by a computer system configured to receive patient-specific data
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`regarding a geometry of an anatomical structure of a patient. (Ex. 1001 at
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`Abstract; 40:63–41:33). The patient-specific data are obtained from well-
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`known imaging methods such as computerized tomography (“CT”) scans,
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`magnetic resonance imaging (MRI), or ultrasounds. (Ex. 1001 at 22:57–64;
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`40:63–41:33). Fig. 24B from the ‘186 Patent (reproduced on the next page)
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`shows an example flowchart (1300)
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`illustrative of
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`the simulated
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`revascularization approach using the patient-specific data:
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`(Ex. 1001 at Fig. 24B).
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`29. The flowchart in Fig. 24B includes steps for using the patient-specific data
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`to create an anatomical model relating to a blood flow characteristic within
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`the anatomical structure (1301), determining a first blood flow rate at at least
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`one point of interest in the model (1302, 1303), modifying the model “such
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`that the effect of narrowings due to disease are removed” (1305),
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`determining a second blood flow rate at a point in the modified model
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`corresponding to the at least one point of interest in the model (1306), and
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`determining a FFR value as a ratio of the second blood flow rate to the first
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`blood flow rate (1307). (Ex. 1001 at Abstract; 40:63–41:33).
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`30. As I describe below, the prior art shows that it was known to determine FFR
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`as a ratio of theoretical blood flow in a location with a stenosis removed to a
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`blood flow in the same location with the stenosis. The flowchart (1300)
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`above and the claims of the ‘186 Patent, which I discuss below, recite
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`nothing more than the clinical definition of FFR.
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`LEVEL OF SKILL IN THE ART
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`31.
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`I was asked to provide my opinion about the experience and background a
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`person of ordinary skill in the art of the ‘186 Patent would have had as of
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`March 31, 2014. In my opinion, such a person of skill in the art would have
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`at least an advanced degree in mechanical engineering, biomedical
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`engineering, medical physics, or a related field, with knowledge of fluid
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`dynamics and at least five years experience in coronary physiology.
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`32.
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`I believe that I was a person of ordinary skill in the art as of March 31, 2014.
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`Furthermore, I believe that I can provide an opinion today regarding what
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`those of skill in the art would have known and understood as of March 31,
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`2014.
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`CLAIM CONSTRUCTION
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`33.
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`I have been informed that the challenged claims must be given their
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`“broadest reasonable construction in light of the specification” of the ‘186
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`Patent. Under this broadest reasonable interpretation standard, claim terms
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`are generally given their ordinary and customary meaning, as would be
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`understood by a person of skill in the art in the context of the entire
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`disclosure.
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`34.
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`I have been informed that if a special definition for a claim term is proffered,
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`it must be described in the specification “with reasonable clarity,
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`deliberateness, and precision.” Absent such a special definition, limitations
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`are not to be read from the specification into the claims. Therefore, where
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`not specified, a person of skill in the art would have understood all the terms
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`of each of the claims of the ‘186 Patent to have their ordinary and customary
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`meaning. With the exception of the terms that I address immediately below,
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`I have applied the ordinary and customary meaning of each claim term of the
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`‘186 Patent in my analysis.
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`“point of interest”
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`35. The ‘186 Patent claims do not recite how the “point of interest” is identified
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`or whether it corresponds to a stenosis location, healthy location, or
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`bifurcation/trifurcation in coronary arteries. Similarly, the ‘186 Patent
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`specification does not attribute special meaning to the term “point of
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`interest,” but instead uses the term generally. (See, e.g., Ex. 1001 at 2:55–
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`58; 3:16–26; 4:4–23; 41:27–54).
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`36. One of skill in the art would understand coronary arteries may include many
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`“points of interest,” including locations in an artery of stenosis or locations
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`that do not contain a stenosis or locations corresponding to bifurcations or
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`trifurcations of arteries or a crown of a vessel. When determining FFR for a
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`patient, the stenosis locations provide useful information for assessing
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`vascular health. In particular, the CSA of a stenosis has a significant effect
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`on coronary pressure drop and FFR. (Ex. 1011 at 1331–1333, Fig. 5). For
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`this reason, one of ordinary skill in the art would understand “point of
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`interest” to at least include a location within a coronary artery that is at or in
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`proximity to a stenosis.
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`“using a parameter associated with at least one of a level of hyperemia, a level of
`exercise, or a medication”
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`37.
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`I have been informed the claim phrase “using a parameter associated with at
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`least one of a level of hyperemia, a level of exercise, or a medication”
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`indicates a Markush group, which means the claims recite a list of
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`alternatively useable species that is interpreted as an “or.” Thus, under the
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`broadest reasonable construction, I understand this claim is satisfied by the
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`disclosure of one of a level of hyperemia, a level of exercise, or a
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`medication. In the alternative, if this term is construed as requiring each of a
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`level of hyperemia, a level of exercise, and a medication, I have provided
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`my opinion consistent with that interpretation as well.
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`“using a parameter that relates to a coronary artery resistance of the patient, an
`aortic blood pressure of the patient, or a heart rate of the patient”
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`38.
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`I have been informed the claim phrase “using a parameter that relates
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`to a coronary artery resistance of the patient, an aortic blood pressure
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`of the patient, or a heart rate of the patient” indicates a Markush
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`group, which means the claims recite a list of alternatively useable
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`species that is interpreted as an “or.” Thus, under the broadest
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`reasonable construction, I understand this claim is satisfied by the
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`disclosure of one of a coronary artery resistance of the patient, an
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`aortic blood pressure of the patient, or a heart rate of the patient. In
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`the alternative, if this term is construed as requiring each of a
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`coronary artery resistance of the patient, an aortic blood pressure of
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`the patient, and a heart rate of the patient, I have provided my opinion
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`consistent with that interpretation as well.
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`17
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`“determine a fractional flow reserve value as a ratio of the second blood flow
`rate to the first blood flow rate in the model”
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`39. As described above, FFR is defined as a ratio of a maximal blood flow rate
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`in a location of an artery with a stenosis, divided by a theoretical maximal
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`flow rate at the same location without the stenosis. This is consistent with
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`the specification of the ‘186 Patent which that defines FFR as a “ratio of
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`flow in the model to flow in the revised model: Q/QN” where the “revised
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`model” corresponds to a model where “one or more narrowings caused by
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`disease” are removed. (Ex. 1001 at 40:35–54). This is shown in the flow
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`chart of Figure 24B from the ‘186 Specification:
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`40. The claims of the ‘186 Patent require determination of a FFR value by
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`comparing blood flow rates in the first and second models. Step 1307 in the
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`above flow chart corresponds to this claim language and makes clear that
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`“determine a fractional flow reserve value as a ratio of the second blood
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`flow rate [QN - revised model] to the first blood flow rate in the model [Q -
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`original model]” is determined by dividing Q by QN. Accordingly, one of
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`skill in the art would understand the proper construction of “a fractional flow
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`reserve value as a ratio of the second blood flow rate to the first blood flow
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`rate in the model” is the ratio where the first blood flow rate is divided by
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`the second blood flow rate.
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`41. This construction is also correct as it would result in an FFR value of less
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`than 1.0, which is how FFR is measured in the art. In particular, an FFR of
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`less than 0.8 is indicative of significant narrowing of the artery, requiring
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`intervention. (Ex. 1014 at 1703; Ex. 1001 at 35:50–63; 49:45–50).
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`OVERVIEW OF PRIOR ART—THE LAVI PUBLICATION
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`42. As part of my work in this proceeding, I was asked to review U.S. Patent
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`Publication No. 2014/0200867 to Lavi et al. (“Lavi”) (Ex. 1005).
`
`43. Lavi is titled “Vascular Flow Assessment” and is generally directed to a
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`method for vascular assessment. (Ex. 1005 at Title, Abstract).
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`44. Lavi describes modeling and assessing vascular flow based on patient data,
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`including 2D angiographic images of a portion of a vasculature of a subject.
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`(Ex. 1005 at Abstract). In certain embodiments, the method and system
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`involves processing the images to produce what Lavi refers to as a tree
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`model. (Ex. 1005 at ¶¶57, 226–229). An example of the tree model is
`
`shown in Figure 3B of Lavi reproduced below:
`
`(Ex. 1005 at Fig. 3B).
`
`
`
`45. The method further includes obtaining a flow characteristic of the stenotic
`
`model and calculating an index indicative of vascular function based, at least
`
`in part, on the flow characteristic in the stenotic model. (Ex. 1005 at
`
`Abstract). For example, the index can be calculated based on a volume of a
`
`crown in the model and on a contribution of a stenosed vessel to the
`
`resistance to blood flow in the crown. (Ex. 1005 at ¶46).
`
`
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`20
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`CATHWORKS EXHIBIT 1002
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`
`
`46. Lavi further discloses another embodiment where a second model is created
`
`by modifying the first model so that “one or more stenoses present in the
`
`patient’s vascular system are modeled as if they had been revascularized.”
`
`(Ex. 1005 at ¶47). Lavi discloses that the first model and second model are
`
`compared, and an index indicative of the potential effect of revascularization
`
`is produced. (Ex. 1005 at ¶48). Lavi discloses that this index can be a
`
`fractional flow reserve, as known in the art. (Ex. 1005 at ¶49).
`
`47. Figure 9 of Lavi shows a flow chart of an example embodiment:
`
`(Ex. 1005 at Fig. 9).
`
`SUMMARY OF OPINIONS
`
`
`
`48. As discussed in more detail below, my review of Lavi and its disclosure
`
`demonstrates that the concepts of the ‘186 Patent were not new as of March
`
`
`
`21
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`CATHWORKS EXHIBIT 1002
`Page 21 of 55
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`
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`31, 2014. Specifically, as discussed in detail below, Lavi discloses to those
`
`of ordinary skill in the art the use of a computer to model patient-specific
`
`data regarding the geometry of an anatomical structure, determine a blood
`
`flow rate at a point of interest within the model, modify the lumen diameter
`
`of the model at the point of interest, compute a second blood flow rate at the
`
`point of interest, and determine a FFR as a ratio of the second blood flow
`
`rate to the first blood flow rate in the model.
`
`49.
`
`In performing my analysis, I have included claim charts below that show the
`
`claim language on the left-hand side and a relevant disclosure exemplary of
`
`Lavi on the right-hand side. For Claim 1, I have made bold the claim
`
`language at issue in my analysis.
`
`50.
`
`
`
`Claim 1
`A system for determining
`cardiovascular information for a
`patient, the system comprising:
`
`at least one computer system
`configured to:
`
`receive patient-specific data
`regarding a geometry of an
`anatomical structure of a patient;
`
`create an anatomic model
`representing at least a portion of the
`anatomical structure of the patient
`
`Lavi
`“The present invention, in some
`embodiments thereof, relates to vascular
`flow assessment and, more particularly,
`but not exclusively, to modeling vascular
`flow and to assessing vascular flow.”
`
`(Ex. 1005 at ¶1).
`
`“In some embodiments of the invention,
`one or more models of a patient’s vascular
`system are produced.”
`
`(Ex. 1005 at ¶44).
`
`“27. A system for vascular assessment
`
`
`
`22
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`CATHWORKS EXHIBIT 1002
`Page 22 of 55
`
`
`
`Claim 1
`based on the patient-specific data
`
`comprising:
`
`Lavi
`
`identify at least one point of interest
`within the anatomical structure of the
`patient in the anatomic model;
`
`a plurality of imaging devices configured
`for capturing a plurality of 2D images of a
`vasculature of a subject; and
`
`determine a first blood flow rate
`within the anatomical structure of the
`patient at the at least one point of
`interest in the anatomic model;
`
`a computer configured for receiving said
`plurality of 2D images and executing the
`method according to claim 1.”
`
`(Ex. 1005 at Claim 27).
`
`modify a lumen diameter of the
`anatomic model at the point of
`interest;
`
`
`
`compute a second blood flow rate
`based on the modified lumen
`diameter of the anatomic model at
`the point of interest;
`
`determine a fractional flow reserve
`value as a ratio of the second blood
`flow rate to the first blood flow rate
`in the model.
`
`51. The representative citations in Lavi make clear that its disclosed system for
`
`vascular (flow) assessment is a system for determining cardiovascular
`
`information for a patient as that phrase is used in Claim 1.
`
`52.
`
`
`
`Claim 1
`A system for determining
`cardiovascular information for
`a patient, the system
`comprising:
`
`Lavi
`“The computer 2210 is optionally configured to:
`accept data from the plurality of imaging devices
`2205; produce a tree model of the patient’s
`vascular system, wherein the tree model comprises
`geometric measurements of the patient’s vascular
`
`
`
`23
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`CATHWORKS EXHIBIT 1002
`Page 23 of 55
`
`
`
`Claim 1
`at least one computer system
`configured to:
`
`receive patient-specific data
`regarding a geometry of an
`anatomical structure of a
`patient;
`
`create an anatomic model
`representing at least a portion
`of the anatomical structure of
`the patient based on the
`patient-specific data
`
`identify at least one point of
`interest within the anatomical
`structure of the patient in the
`anatomic model;
`
`determine a first blood flow
`rate within the anatomical
`structure of the patient at the
`at least one point of interest in
`the anatomic model;
`
`modify a lumen diameter of
`the anatomic model at the
`point of interest;
`
`compute a second blood flow
`rate based on the modified
`lumen diameter of the
`anatomic model at the point of
`interest;
`
`determine a fractional flow
`reserve value as a ratio of the
`second blood flow rate to the
`first blood flow rate in the
`
`Lavi
`system at one or more locations along a vessel
`centerline of at least one branch of the patient’s
`vascular system, using at least some of the
`plurality of captured 2D images; and produce a
`model of flow characteristics of the tree model.”
`
`(Ex. 1005 at ¶395).
`
`(Ex. 1005 at Fig. 12A).
`
`
`
`
`
`
`
`24
`
`CATHWORKS EXHIBIT 1002
`Page 24 of 55
`
`
`
`Claim 1
`
`Lavi
`
`model.
`
`(Ex. 1005 at Figure 1)
`
`“The original image 110 depicts a typical
`angiogram 2D image.”
`
`(Ex. 1005 at ¶205–206).
`
`53. Lavi discloses a computer system configured to perform a number of tasks.
`
`For example, Lavi discloses a computer configured to receive patient-
`
`specific data. (Ex. 1005 at ¶395). Lavi discloses that the patient-specific
`
`data for constructing a vascular model may be collected from various
`
`sources. (Ex. 1005 at ¶171). In some instances, the data is from minimally
`
`invasive angiographic images, taken from different viewing angles. (Ex.
`
`1005 at ¶172). Alternatively, the data can be from CT scans. (Ex. 1005 at
`
`¶173).
`
`54.
`
`
`
`Claim 1
`A system for determining
`cardiovascular information for a
`patient, the system comprising:
`
`at least one computer system
`configured to:
`
`receive patient-specific data
`regarding a geometry of an
`anatomical structure of a patient;
`
`create an anatomic model
`representing at least a portion of
`
`Lavi
`“The computer 2210 is optionally
`configured to: accept data from the
`plurality of imaging device 2235; produce
`a tree model of the patient’s vascular
`system, wherein the tree model comprises
`geometric measurements of the patient’s
`vascular system at one or more locations
`along a vessel centerline of at least one
`branch of the patient’s vascular system,
`using at least some of the plurality of
`captured 2D images; and produce a model
`of flow characteristics of the tree model.”
`
`
`
`25
`
`CATHWORKS EXHIBIT 1002
`Page 25 of 55
`
`
`
`Lavi
`(Ex. 1005 at ¶401).
`
`“The example method for producing a
`geometric model of a vascular system
`optionally includes:
`
`extracting vessel center-lines from at least
`two 2D projections;
`
`identifying homologous vessels in the
`different projections; and
`
`applying epipolar geometry methods to
`obtain a 3D model of the coronary tree.”
`
`(Ex. 1005 at ¶¶210–212).
`
`Claim 1
`the anatomical structure of the
`patient based on the patient-
`specific data
`
`identify at least one point of interest
`within the anatomical structure of the
`patient in the anatomic model;
`
`determine a first blood flow rate
`within the anatomical structure of the
`patient at the at least one point of
`interest in the anatomic model;
`
`modify a lumen diameter of the
`anatomic model at the point of
`interest;
`
`compute a second blood flow rate
`based on the modified lumen
`diameter of the anatomic model at
`the point of interest;
`
`determine a fractional flow reserve
`value as a ratio of the second blood
`flow rate to the first blood flow rate
`in the model.
`
`55. Lavi discloses that the computer 2210 creates, for example, a tree model of a
`
`patient’s vascular system using the 2D or 3D images. (Ex. 1005 at ¶¶136,
`
`174, 176–184, 226–236, 312, Fig. 3). The tree model may include a 3D
`
`model of the vascular system or a 2D representation of the vascular system
`
`that identifies vascular dimensions. (Ex. 1005 at ¶¶136, 312). According to
`
`Lavi, in some embodiments the model can include location, orientation, and
`
`
`
`26
`
`CATHWORKS EXHIBIT 1002
`Page 26 of 55
`
`
`
`diameter of vessels. (Ex. 1005 at ¶181). Optionally, the tree model can also
`
`comprise flow characteristics. (Ex. 1005 at ¶181).
`
`56. Lavi describes that the tree model is a “tree data structure having nodes
`
`linked by curvilinear segments.
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