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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner
`
`
`
`DECLARATION OF MICHAEL JONES
`SUBMITTED IN SUPPORT OF PETITIONER’S REPLIES AND
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`AMEND
`
`IPR2020-01341
`IPR2020-01342
`U.S. Pat. No. 8,142,413
`
`IPR2020-01343
`IPR2020-01344
`U.S. Pat. No. RE 46,116
`
`
`IPR2020-01344
`
`Medtronic Ex-1807
`Medtronic v. Teleflex
`Page 1 of 76
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`TABLE OF CONTENTS
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`Page
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`V.
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`VI.
`
`VI.
`
`
`INTRODUCTION ........................................................................................... 1
`I.
`QUALIFICATIONS ........................................................................................ 1
`II.
`III. LEVEL OF ORDINARY SKILL IN THE ART .............................................. 3
`IV. MECHANISM OF BACK-UP FORCE .......................................................... 3
`A. A Catheter-in-Catheter Assembly Decreases the Distance that
`an Interventional Cardiology Device Travels in the Vasculature. ......... 7
`A Catheter-in-Catheter Assembly Increases the Moment-of-
`Inertia, Which is an Increase in the Stiffness of the Assembly. ............ 8
`ITOU IS SUFFICIENTLY SIZED TO RECEIVE A BALLOON OR
`STENT CATHETER ....................................................................................... 9
`ITOU DESCRIBES A SYSTEM IN WHICH THE SUCTION
`CATHETER REMAINS SEATED IN RESPONSE TO AN
`OPPOSING BACKWARD FORCE EXERTED BY THE
`PROTECTIVE CATHETER 5 ......................................................................16
`VII. A POSITA WOULD UNDERSTAND THAT THE ENTIRE
`INTERIOR LUMEN OF ITOU’S CATHETER IS LUBRICOUS
`AND NOT TACKY .......................................................................................18
`ITOU IN COMBINATION WITH RESSEMANN .......................................20
`A.
`Rationale for Modifying Itou with Collar 2141 ..................................20
`1.
`Use of flexibility transition members in the art ........................30
`VIII. MODIFICATION OF ITOU WITH KATAISHI ...........................................35
`IX. KONTOS .......................................................................................................41
`A. Kontos Resists Axial and Shear Forces that Would Otherwise
`Tend to Dislodge the Guide Catheter. .................................................43
`Kontos Does Not Require a Narrow Tube 16 to Protect the
`PTCA Catheter Contained Therein. ....................................................46
`After Replacing the Funnel with a Side Opening, Kontos’s
`Support Catheter 10 could be made bigger .........................................49
`D. Modifying Kontos with Ressemann’s support collar ..........................58
`E. Modifying Kontos with Kataishi’s shape ............................................66
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`B.
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`B.
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`C.
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`X. GIVEN RESSEMANN’S SUPPORT COLLAR 2141, AND THE
`SHAPE OF KATAISHI’S DESIGN, THE ULTIMATE PROXIMAL
`SIDE OPENING SHAPE IS AN OBVIOUS DESIGN CHOICE
`DETERMINED THROUGH ROUTINE EXPERIMENTATION AND
`OPTIMIZATION ...........................................................................................68
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`I.
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`Introduction
`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
`1.
`
`Inc. and Medtronic Vascular, Inc. (“Medtronic”) as an independent expert.
`
`2.
`
`I am informed that Medtronic intends to use my opinions in support of
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`petitions pending at the Patent Trial and Appeal Board (“PTAB”) concerning U.S.
`
`Patent Nos. 8,142,413, and RE46,116 (the “Teleflex Patents”): IPR2020-01341,
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`IPR2020-01342, IPR2020-01343, IPR2020-01344.
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`3.
`
`I have been asked to provide my opinion on the disclosures of certain
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`patents and articles in view of the knowledge of a POSITA as of the date of
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`invention of the Teleflex Patents.
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`4.
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`I am informed that the parties dispute the date of invention of the
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`patents that are the subject of the IPRs. My opinions herein are the same whether
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`the relevant date is May 3, 2006 or early 2005.
`
`5.
`
`I make this Declaration based on my personal education, experience,
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`and knowledge of medical device product development since the mid-1980s. I
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`have also reviewed the materials cited herein.
`
`II. Qualifications
`6. My curriculum vitae is attached as Appendix A.
`
`7.
`
`I received a Bachelor of Science degree in Chemical Engineering
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`from the University of California, Berkeley in 1984. I later earned a Master of
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`
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`Science degree in Engineering, Mechanics and Materials, in 1995 from California
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`State University, Long Beach.
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`8.
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`From the mid-1980s through the late-1990s I worked as an engineer
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`responsible for various aspects of medical device design, development, and
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`manufacturing for products that included catheters for treating thrombo-embolic
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`stroke, catheters for treating subarachnoid hemorrhage, balloon catheters for
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`treating vascular spasm (Micro Therapeutics, Inc.), an electrosurgical balloon
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`catheter and a ureteral stent product line (Applied Medical Resources), urological
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`balloon catheters (Baxter Healthcare), embolectomy catheters, endo tracheal and
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`tracheostomy tubes, and angioplasty catheters (Shiley).
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`9.
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`Since 1997, I have worked at Design Development and Fabrication,
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`Inc. in contract mechanical engineering, focused on product design and
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`development. My projects included prototype designs for minimally invasive,
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`surgical, and implantable devices, development and fabrication for surgical
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`devices, test fixture design and fabrication, and process validation in support of
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`PMA filings. Clients included: Edwards Lifesciences Inc., SenoRx Inc, Vascular
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`Control Systems Inc., Micro Therapeutics and Neuroperfusion.
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`10. Over the course of my work, I have been named as an inventor on
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`over 100 patents.
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`11.
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`I am being compensated at $425 per hour for my time, and my
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`compensation is not contingent on the results of these proceedings.
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`III. Level of Ordinary Skill in the Art
`I understand that Medtronic proposed the following level of ordinary
`12.
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`skill in the art for these IPRs: a person of ordinary skill in the art (“POSITA”) at
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`the time of the alleged invention would have had: (a) a medical degree; (b)
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`completed a coronary intervention training program; and (c) experience working as
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`an interventional cardiologist. Alternatively, a POSITA would have: (a) an
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`undergraduate degree in engineering, such as mechanical or biomedical
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`engineering; and (b) three years of experience designing medical devices,
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`including catheters or catheter-deployable devices. Extensive experience and
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`technical training might substitute for education, and advanced degrees might
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`substitute for experience. Additionally, a POSITA with a medical degree may have
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`access to a POSITA with an engineering degree, and one with an engineering
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`degree might have access to one with a medical degree.
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`13. Based on my education and experience, I meet the definition of a
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`POSITA. My opinions herein are provided with respect to this definition.
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`IV. Mechanism of Back-up Force
` I have been asked to opine on the mechanism by which a
`14.
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`catheter-in-catheter assembly provides additional back-up support for deployment
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`of devices, such as guidewires, balloon catheters, stents, and stent catheters, to a
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`lesion located in a coronary artery.
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`15. By way of background, tough lesions located deep within the
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`coronary arteries are difficult to reach. One challenge to treating such distal lesions
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`is the problem of guide catheters dislodging from the coronary ostium when a
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`guidewire, balloon catheter, stent or stent catheter meets a particularly tough distal
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`lesion. This is shown schematically in the figure below. Image “a” illustrates by
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`arrows the force pushing the guide catheter away from the ostium and coronary
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`artery due to a guidewire engaging a tough stenosis, for example.
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`Ex-1814 (Takahiko Suzuki, M.D.)
`http://cct.gr.jp/2003/books/bookspdf/suzuki05cii.pdf
`16. Prior to the 2005-2006 timeframe, a known solution to prevent
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`back-out of the guide catheter was the use of a “double-catheter,” sometimes
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`
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`referred to as a “catheter-in-catheter assembly.” By way of the example provided in
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`image “b” above, Dr. Takahiko Suzuki, M.D. of Toyohashi Heart Center, describes
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`using a 120 cm 6 Fr Goodman Road-Master™ catheter in a 8 Fr guide catheter “to
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`make a ‘double-catheter’” to achieve the “back-up force needed to cross [a] wire”
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`in an ostial RCA or LCA lesion.” Ex-1814.
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`17. Similarly, in a 2004 article, Takahashi quantitatively illustrates the
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`increased back-up support of a catheter-in-catheter system. See Ex-10101. In
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`particular, Takahashi describes achieving the backup support of an 8 Fr guide
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`catheter with a 5 Fr-in-6 Fr system. Id. A figure of Takahashi’s catheter-in-catheter
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`assembly deploying a balloon catheter is shown below.
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`1 I cite the references I discuss in this declaration according to the way they are
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`numbered in IPR2020-01341 (e.g., Ex-1010.). However, I understand that the
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`same set of exhibits were filed in each of the four IPRs concerning the two Root
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`patents, always retaining the same final two numbers. There may be exceptions to
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`this general rule, where slightly different versions of these documents were filed in
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`each of the IPRs, although there is much duplication of content. When I cite these,
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`I indicate the respective IPR number.
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`Id., Fig. 2.
`18. Suzuki and Takahashi disclose a catheter-in-catheter system that
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`
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`improves back-up support. Takahashi teaches that the distance between the inner
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`diameters of the nested catheters is less than 1 French. Ex-1010 (disclosing an
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`inner diameter of the outer 6 Fr catheter of 0.071 inches and inner diameter of the
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`inner 5 Fr catheter of 0.059 inches—a difference of 0.012 inches (or 0.30 mm,
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`which is less than 0.33 mm (1/3 mm = 1 Fr)). Suzuki teaches improved back-up
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`support without necessitating a 1 French relationship between the inner diameters
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`of the nested catheters (i.e., describing a 6Fr in 8Fr system).
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`19. As shown in Suzuki, a catheter-in-catheter assembly can provide
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`back-up support even if the distance between the inner diameters of the nested
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`catheter is greater than 1 French. This is for two reasons. First, because the inner
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`catheter extends beyond the ostium and into the coronary artery, the
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`catheter-in-catheter assembly decreases the distance that an interventional
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`cardiology device travels in the vasculature. Second, by making a “double
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`catheter,” the catheter-in-catheter assembly is stiffened, which leads to additional
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`back-up support.
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`A. A Catheter-in-Catheter Assembly Decreases the Distance that an
`Interventional Cardiology Device Travels in the Vasculature.
` By using a catheter-in-catheter assembly, it is possible to extend the
`
`20.
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`inner catheter (sometime referred to as the “child catheter”) beyond the ostium of
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`the coronary artery. In so doing, the interventional cardiology device has to travel a
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`shorter distance in the vasculature, which in turn reduces the amount of force
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`necessary to advance the interventional cardiology device to the target location.
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`This is because the vasculature can be tortuous and/or calcified, thereby requiring
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`more force to advance the interventional cardiology device.
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`21. As discussed above, catheters are generally lined with a lubricious
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`coating, such as Teflon. See Ex-1015, 548. This lining is intended to promote
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`trackability of an interventional cardiology device within the catheter assembly,
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`and reduces the amount of force necessary to advance the interventional cardiology
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`device to the target location. This, in turn, results in reducing the axial and shear
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`forces exerted by an interventional cardiology device that would otherwise tend to
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`dislodge from the ostium of a coronary artery the distal portion of a catheter-in-
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`catheter assembly.
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`B. A Catheter-in-Catheter Assembly Increases the Moment-of-
`Inertia, Which is an Increase in the Stiffness of the Assembly.
`22. The mechanisms involved in the movement of catheters while in the
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`vasculature explains how a catheter-in-catheter assembly provides back-up
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`support. In particular, the following mechanical properties of catheters influence
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`back-up support: flexural rigidity, torsional rigidity, and buckling force. See
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`Ex-1834, Figs. 7, 14, 11:45-48, 18:26-32. These mechanical properties are
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`proportional to the moment of intertia, and the construction material. Id.
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` The moment of inertia, 𝐼𝐼0, of the cross section of a catheter with
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`23.
`
`respect to its neutral axis, is expressed by the following, and is proportional to
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`flexural rigidity and buckling force. Id. at 12. The cross section of a catheter is a
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`hollow circle with an outer diameter D and an inner diameter d. Id.
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`𝐼𝐼0=𝜋𝜋(𝐷𝐷4−𝑑𝑑4)
`64
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`
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`24. The polar moment of inertia of a catheter shaft with outer diameter D
`
`and inner diameter d is expressed as follows, and is proportional to the torsional
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`
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`rigidity of a catheter. Id., 12-15.
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`𝐽𝐽0𝑐𝑐𝑐𝑐𝑐𝑐ℎ𝑒𝑒𝑐𝑐𝑒𝑒𝑒𝑒=𝜋𝜋(𝐷𝐷4−𝑑𝑑4)
`32
`
`
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`25. From these equations it is clear that when placing a catheter within a
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`catheter, the outer diameter remains defined and the effective inner diameter
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`decreases, which results in the following consequences:
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`a.
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`b.
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`c.
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`Flexural rigidity increases;
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`Torsional rigidity increases; and
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`Resistance to buckling force increases.
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`26. The polar moment of inertia of a catheter shaft with outer diameter D
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`and inner diameter d is expressed as follows, and is proportional to the torsional
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`rigidity of a catheter. Id., 12-15.
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`27. The increase in these properties is why backup support is increased
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`when a catheter-in-catheter system (whether a full-length catheter in a full-length
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`catheter or rapid-exchange catheter within a full-length catheter) is used instead of
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`a single-guide catheter. It also explains why Suzuki—despite not describing a 1
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`French relationship—provides back-up support.
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`V.
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`Itou is Sufficiently Sized to Receive a Balloon or Stent Catheter
`I have been asked to opine on whether suction catheter (2) of Itou is
`28.
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`sufficiently sized to receive a balloon or stent catheter. In connection with my
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`analysis, I have reviewed the position of Medtronic on this limited topic, as well as
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`Patent Owner’s position as articulated in Patent Owner’s response and the
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`declaration of Peter T. Keith. See Paper 1, 29-31; Paper , Paper 23
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`(IPR2020-00135), 37-40; Ex-2138, ¶¶ 170-73; IPR2020-01343, Paper 21, 33-38.
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`29. With reference to Figures 1 and 3 of Itou, Itou teaches an assembly
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`consisting of a guidewire (6), which fits within a distal end protective catheter (5).
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`Catheter (5) fits within suction catheter (2), and catheter (2) fits within guide
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`catheter (1).
`
`Ex-1007, Figs. 1A-F.
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`Id., Fig. 3 (illustrating suction catheter 2, color added).
`30. Table 1 of Itou teaches that the inner diameter of catheter 2 is 1.5 mm,
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`which is 0.059 inches. Id., 7:55-65. In the 2005 period, there were commercially
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`available balloon and stent catheters that could be delivered through a guide
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`catheter that had an inner diameter (“ID”) of >0.056 inches. One example is the 5
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`Fr Heartrail catheter that has an inner diameter of 0.059 inches. Ex-1010, 452.
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`Such an inner diameter can “accept normal balloons or stent delivery systems less
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`than 4.0 mm in diameter.” Id.
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`31.
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`I am aware that Itou teaches that catheter 5 is inserted into catheter 2,
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`and the catheters are together advanced through guiding catheter 1. Ex-1007, 5:29-
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`51. I am also aware that Itou teaches that suction catheter 5 should then be
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`removed from catheter 2. Id., 7:13-19.
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`32.
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`I am also aware that Itou teaches that when the distal part of the distal
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`tubular portion (24) is extended into the coronary artery, the proximal part of
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`tubular portion (24) remains within the guide catheter. Id., 5:35-42.
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`33.
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`I understand Patent Owner has argued that the “effective” size of the
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`opening of catheter 2 is smaller than Itou discloses. See Paper 23, 44-46; Ex-2138
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`(IPR2020-00135), ¶¶ 170-73; IPR2020-01343, Paper 21, 36-37. Patent Owner
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`argues that wire-like portion 25 to catheter 2 partially blocks the proximal opening
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`of catheter 2. Id. Mr. Keith argues that wire 25 reduces the effective size of the
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`lumen from 0.059 inches to 0.046 inches. Ex-2138, ¶ 174. Patent Owner argues
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`that once suction catheter 2 was placed in a guide catheter, it would be impossible
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`to advance a balloon or stent into catheter 2 for delivery into the coronary
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`vasculature.
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`34.
`
`I disagree with Mr. Keith and Patent Owner’s position.
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`35. First, as reported in Itou’s table 1, the wire-like pushrod, 25, does
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`have a diameter of 0.45 mm (~0.017 inches). However, the portion of wire 25 with
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`a full, circumferential cross-sectional shape does not abut the proximal opening of
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`tubular portion 24. Itou is explicit that, adjacent the location of tubular portion 24’s
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`proximal opening, pushrod 25 is “crushed into a form of a flat plate.” Ex-1007,
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`4:32-36, Figs. 3, 4. A change in diameter of pushrod 25 is not unsurprising.
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`Tapering a shaft along its longitudinal axis in the proximal to distal direction was
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`known. Ex-1063, [0025].
`
`36. Second, catheter (2) bends. It must, in order for its distal tubular
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`portion to be maneuverable into the coronary vasculature. See, e.g., Ex-1007,
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`Abstract, Fig. 6. A POSITA would understand Itou’s disclosure to teach that
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`catheter (2) has varying rigidity along its length, such that its proximal portion is
`
`more rigid, and its distal portion is more flexible. This is not unique. The art taught
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`that balloon angioplasty catheters should have a decreasing rigidity along their
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`proximal to distal lengths. Ex-1063, [0025]. The same was taught for embolic
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`protection catheters, as I discuss herein, in regard to Ressemann, as well as for
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`aspiration catheters. Ex-1019, 2:60-65 (“The catheters are provided with varying
`
`flexibility along the length of the shaft, such that they are soft and flexible enough
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`to be navigated through the vasculature of a patient without causing damage, but
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`are stiff enough to sustain the axial push required to position the catheter properly
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`and to sustain the aspiration pressures.”).
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`37. Third, the proximal opening of catheter (2) is cut at an oblique angle,
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`as illustrated below.
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`Ex-1007, Figs. 3 (left), 4.
`38. The three features I discuss above — (a) the flattening of wire (25)
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`adjacent to the proximal opening of catheter (2), (b) catheter 2’s flexibility, and (c)
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`the angle of the proximal opening means that the proximal opening of catheter (2)
`
`
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`would readily accept a balloon catheter or stent catheter once catheter 2 was
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`positioned within a guide catheter as shown in Fig. 6.
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`39.
`
`In order for wire 25 to obstruct Itou in the manner that Patent Owner
`
`and Mr. Keith allege, Itou’s catheter 2 would have to be entirely rigid, which it is
`
`not.
`
`40.
`
`In the alternative, for wire 25 to obstruct Itou in the manner suggested
`
`by Patent Owner and Mr. Keith, catheter 2 would have to be modified such that the
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`wire 25 is welded to proximal end portion 231 without any flattening of the wire
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`adjacent the opening. See Ex-1007, 4:32-36. Such a modification would look like
`
`the modified Itou Fig. 3, below.
`
`
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`Id., Fig. 3 (modified).
`41. This is clearly not what Itou contemplates or teaches. Nor would a
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`
`
`person of ordinary skill in the art understand Itou to disclose such an obstruction at
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`the proximal opening.
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`42. Moreover, even if Itou’s proximal opening was obstructed by wire 25
`
`so that the “effective size” of catheter 2’s opening went from 0.059 inches (1.5mm)
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`to 0.046 inches (1.16 mm) as Patent Owner and Mr. Keith allege (it is not), such an
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`opening is still large enough to receive a standard coronary stent.
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`43. By the early 2000s, standard coronary stents, guidewires, balloon
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`catheters, and stent catheters were available with an outer diameter sufficient to
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`pass through Itou’s allegedly constricted opening of 0.046 inches. See Ex-1015,
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`641 (“All current slotted tube designs are ‘bare mounted’ on a delivery balloon,
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`with deflated profiles smaller than 0.040-in. (1mm)…”); Ex-1802, 104 (Genic®
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`stent with less than 0.9 mm (0.035 inch) profile), 143 (Lunar stent with 0.0382
`
`inch profile), 269 (Spiral Force stent with 0.039 to 0.042 inch profile), 274
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`(Tsunami stent with 0.95 mm (0.038 inch) profile); see also, Ex-1803, 4:46-56;
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`Ex-1804, Table 2.
`
`44. Such sized interventional devices would have sufficient clearance to
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`be received into a proximal diameter opening of 0.046 inches. Even in the case of a
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`stent with an outer diameter (“OD”) of 0.044 inches, there would be enough
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`clearance because the size tolerances on the diameter dimensions can be very
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`precise (less than plus or minus 0.02 mm, which is less than 0.0008 inches) due to
`
`precision extrusions.
`
`45. Current catheter construction technology using PTFE liners with a tie
`
`layer, stainless steel braids and Pebax outer jackets, and run a tolerance of ±.001
`
`inch on the inner diameter and ±.003 inch on the outer diameter of the completed
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`catheter body for catheters up to 4.4 mm in outer diameter. These tolerances were
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`typical in 2005-2006.
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`46. For the reasons stated above, it is my opinion that the lumen of Itou’s
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`suction catheter 2 is suitable for receiving a stent catheter once catheter 2 has been
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`advanced through a guide catheter and has been partially extended from the guide
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`catheter’s distal end, and when the proximal opening of catheter 2’s tubular portion
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`is still within the guide catheter.
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`VI.
`
`Itou Describes a System in Which the Suction Catheter Remains Seated
`in Response to an Opposing Backward Force Exerted by the Protective
`Catheter 5
`Itou describe as system that includes nested devices, as illustrated in
`47.
`
`Itou’s Fig. 5, shown below.
`
`
`
`48.
`
`Itou states:
`
`[T]he suction catheter 2 is disposed in the lumen of the guiding catheter
`1; the distal end of the distal end protective catheter 5 is inserted in the
`lumen of the suction catheter 2; and the guide wire 6 is inserted in the
`lumen of the distal end protective catheter 5.
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`
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`Ex-1007, 5:12-17.
`Itou also teaches that protective catheter 5 has a tip that is rounded
`49.
`
`and flexible. Id., 4:52-55; see also Fig. 1E. This design explains how catheter 5
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`serves a “protective” function. A rounded, flexible tip is designed to not damage
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`the coronary vasculature.
`
`50.
`
`Itou additionally teaches that protective catheter (5) is longer than
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`suction catheter 2. Id., Table 1. While catheter 2 is described as 1250 mm in length,
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`catheter 5 is described as 1320 mm in length. This makes sense, as, in order to be
`
`“protective,” catheter 5 must extend beyond the distal end of catheter 2.
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`51. As described above in ¶¶ 22-27, supra, having a nested configuration
`
`of a structure within a structure increases the moment of inertia of a catheter
`
`system and increases backup support. In the case of the distal end protective
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`catheter 5 disposed within suction catheter 2, which is disposed within guiding
`
`catheter 1, when the distal end protective catheter 5 contacts the coronary
`
`vasculature when disposed beyond the distal end of the suction catheter, the
`
`increased backup support found due to the nested nature of the suction catheter 2
`
`within guiding catheter 1, would result in the suction catheter remaining seated in
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`response to an opposing backward force exerted by the protective catheter 5 when
`
`it came into contact with the vasculature.
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`
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`VII. A POSITA Would Understand that the Entire Interior Lumen of Itou’s
`Catheter is Lubricous and not Tacky
`I have been asked to describe a POSITA’s understanding of the
`52.
`
`characteristics of the interior lumen of Itou’s suction catheter 2. Itou discloses that
`
`its guiding catheter 1 includes an inner layer 110 “made of a resin material having
`
`a sliding property such as a fluorocarbon resin represented by PTFE.” Ex-1007,
`
`3:30-33. Itou describes its suction catheter 2 as having a “tubular portion 24 [that]
`
`includes a tubular body portion 21 which in turn includes an inner layer 210 made
`
`of a resin material having a sliding property such as a fluorocarbon resin
`
`represented by PTFE.” Id., 3:50-54.
`
`53. Notably, having a lumen with an inner layer made of a resin having a
`
`sliding property, or what is known as a lubricious property, was common in the art
`
`at the time of the Teleflex patents. For example, it was well known to a POSITA
`
`that catheters used for the transport of other devices or thrombi should include a
`
`lubricious lining in order to reduce friction. See Ex-1015, 548 (discussing a Teflon
`
`liner in a guide catheter).
`
`54. As mentioned above, Itou discloses that suction catheter 2’s tubular
`
`body 24 comprises a body portion 21 that is lined with, e.g., PTFE. See Ex-1007,
`
`Fig. 3, below. Itou is silent on the lining of portion 23 which also comprise tubular
`
`body 24. POSITA would understand that portion 23 would also include a lining
`
`having a sliding or lubricious property.
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`
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`55.
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`Itou discloses both an interventional device (e.g., protective catheter
`
`5) and foreign matter as having to travel within the entire lumen of tubular portion
`
`24. See, e.g., Ex-1007, 7:13-27, 2:39-42. For example, Itou teaches that catheter 5
`
`is withdrawn from catheter 2 after the catheter assembly is positioned within the
`
`coronary vasculature. Id., Fig. 6, 7:16-19. Additionally, the whole point of a
`
`suction catheter is to remove foreign matter from the vasculature. It was known in
`
`the art to reduce friction within a catheter to line the catheter with a material
`
`having a sliding property. See Ex-1015, 548. For this reason, a POSITA would
`
`understand that the inner lining of portion 23 of tubular portion 24 would have the
`
`same sliding properties as the inner lining of body portion 21.
`
`
`
`Id., Fig. 3.
`
`56. Moreover, the manner in which catheters are typically manufactured
`
`would result in a PTFE lining within tubular body portion 21 as well as portion 23.
`
`The manner in which catheters are typically constructed starts with the lining itself.
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`For example, first a Teflon liner for the entire length of a catheter would be snugly
`
`fit over a support mandrel with a very thin layer of Pebax fused on the top layer of
`
`the PTFE. Then, over the Teflon, would be fitted the braiding or coiling in the
`
`region to have reinforcement, and the collar from portion 23 would also be fitted
`
`over the Teflon. Then, over the braiding/coiling and collar would be fitted the
`
`catheter’s support structure polymer, for example a Pebax layer. A heat shrinking
`
`process would be carried out to pull all the pieces together into a single cohesive
`
`structure. After heat shrinking the heat shrink tubing is peeled off. For at least these
`
`reasons a POSITA would understand the portion 23 of Itou’s suction catheter to
`
`have a sliding property of for example, PTFE, and not a characteristic that is tacky.
`
`This methodology dates back to the early 2000s.
`
`57. Regardless of the exact material, no POSITA would design a suction
`
`catheter that has a sticky or tacky interior.
`
`VIII. Itou in Combination with Ressemann
`A. Rationale for Modifying Itou with Collar 2141
`I have reviewed Petitioner’s arguments regarding reasons to combine
`58.
`
`the proximal opening of Itou’s catheter 2 with Ressemann’s collar 2141, as well as
`
`Patent Owner’s arguments to the contrary. IPR2020-01343, Paper 1, 64-67; Paper
`
`21, 42-55. I agree with Medtronic that a POSITA would have been motivated to
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`
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`make the discussed modification. A schematic showing the modification of Itou
`
`with Ressemann’s support collar 2141 is shown below.
`
`Ex-1007, Fig. 3 (modified with Ressemann’s support collar 2141).
`
`59.
`
`I agree that the modification to Itou with Ressemann’s collar 2141 is
`
`supported by motivations identified by Petitioner, which include:
`
`
`
`1.
`
`2.
`
`to increase the area for receiving a stent and balloon catheter;
`
`the tab portion provides a flexibility transition between the
`
`proximal end of evacuation lumen 140 and shaft 120; and
`
`3.
`
`the support collar reinforces the opening of the lumen.
`
`IPR2020-01343, Paper 1, 64-67.
`
`60. As noted by Medtronic, combining Ressemann’s collar yields at least
`
`two inclines. Notably, Ressemann’s collar has more than two inclines, as shown in
`
`the schematic below at inclines A, B, and C.
`
`
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`Ex-1008, Fig. 16J (annotations showing at least three inclines on the support collar
`
`
`
`at the proximal end (A), the transition from the concave track of the tab portion
`
`and incline (B), and the incline near the distal most portion of the opening (C)).
`
`61. A POSITA would be motivated to modify Itou because the area of
`
`opening provided by the Ressemann collar creates a longer and more gradual
`
`entryway into the lumen of catheter 2. While Itou and Ressemann do not report the
`
`area of each of their angled side openings, these areas can be estimated based on
`
`the figures and dimensions reported in each patent. I compared what the area of the
`
`opening would be based on the inner diameter of Itou’s catheter 2, which is 1.5
`
`mm. Ex-1007, Table 1, 7:60. To compare to Ressemann’s support collar, I scaled
`
`Ressemann’s support collar such that it has the same inner diameter of Itou. Since
`
`Ressemann’s support collar’s inner diameter is ~0.067 inches (1.7mm) (Ex-1008,
`
`
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`23:4), I scaled Ressemann’s collar down by 12% to achieve the same 1.5 mm inner
`
`diameter.
`
`62. Once Itou’s side opening and Ressemann’s collar are equivalently
`
`scaled, I measured the relative length of each configuration’s side opening. I then
`
`approximated the area of the inner opening by an area of an ellipse. By doing so,
`
`the opening area of Ressemann’s support collar—when scaled to the same inner
`
`diameter of Itou—is over 3 times larger than Itou’s angled opening. A schematic of
`
`my analysis is shown below.
`
`Schematic illustrating scaled comparison of Itou’s collar area as compared to
`
`
`
`Ressemann’s collar area.
`
`
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`63. Ressemann’s collar provides two benefits that Itou’s existing metal
`
`collar does not. The first, as Mr. Keith acknowledges, is that the Ressemann collar
`
`is thinner than the Itou collar. IPR2020-01343, Ex-2138, ¶ 187 (explaining the wall
`
`thickness of Itou is 0