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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
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`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.
`
`Patent Owner
`
`
`
`
`
`
`
`DECLARATION OF MICHAEL JONES
`SUBMITTED IN SUPPORT OF PETITIONER’S REPLIES
`
`
`
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`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1807
`Medtronic v. Teleflex
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`Page 1
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`TABLE OF CONTENTS
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`Page
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`B.
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`B.
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`INTRODUCTION ........................................................................................... 1
`I.
`QUALIFICATIONS ........................................................................................ 1
`II.
`III. LEVEL OF ORDINARY SKILL IN THE ART .............................................. 3
`IV. MECHANISM OF BACK-UP FORCE .......................................................... 4
`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 ................................................................................................................ 9
`V.
`VI. RESSEMANN ...............................................................................................17
`A.
`Rationale for Modifying Embodiment 100 with Collar 2141 .............17
`1.
`Use of flexibility transition members in the art ........................19
`Feasibility of Modifying Embodiment 100 with Collar 2141 ............25
`1.
`Ressemann and collar 2141 ......................................................38
`C. Modification of Ressemann to Achieve a 1 Fr. Differential
`between the Evacuation Lumen and the Guide Catheter ....................44
`VII. MODIFICATION OF ITOU WITH RESSEMANN COLLAR 2141 ...........49
`VIII. MODIFICATION OF ITOU OR RESSEMANN WITH KATAISHI ...........57
`IX. KONTOS .......................................................................................................64
`A. Kontos Resists Axial and Shear Forces that Would Otherwise
`Tend to Dislodge the Guide Catheter. .................................................66
`Kontos Does Not Require a Narrow Tube 16 to Protect the
`PTCA Catheter Contained Therein. ....................................................69
`After Replacing the Funnel with a Side Opening, Kontos’s
`Support Catheter 10 could be made bigger .........................................72
`D. Modifying Kontos with Ressemann’s support collar ..........................81
`E. Modifying Kontos with Kataishi’s shape ............................................89
`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
`
`B.
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`C.
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`DETERMINED THROUGH ROUTINE EXPERIMENTATION AND
`OPTIMIZATION ...........................................................................................91
`XI. BY MAY 3, 2006, IT WAS KNOWN IN THE ART TO PROCESS A
`STIFF HYPOTUBE TO IMPROVE STRAIN RELIEF AND
`TRANSITIONING STIFFNESS BETWEEN A HYPOTUBE AND A
`FLEXIBLE CATHETER. ..............................................................................96
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`ii
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`I.
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`Introduction
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`1.
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`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
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`Inc. and Medtronic Vascular, Inc. (“Medtronic”) as an independent expert.
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`2.
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`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. 8,048,032; RE45,380; RE45,776; RE45,760; and RE47,379 (the
`
`“Teleflex Patents”): IPR2020-00126, IPR2020-00127, IPR2020-00128,
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`IPR2020-00129, IPR2020-00130, IPR2020-00132, IPR2020-00134,
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`IPR2020-00135, IPR2020-00136, IPR2020-00137 and IPR2020-00138.
`
`3.
`
`I have been asked to provide my opinion on the disclosures of certain
`
`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.
`
`I am informed that the parties dispute the date of invention of the
`
`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,
`
`and knowledge of medical device product development since the mid-1980s. I
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`have also reviewed the materials cited herein.
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`II. Qualifications
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`6. My curriculum vitae is attached as Appendix A.
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`1
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`7.
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`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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`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).
`
`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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`2
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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
`
`12.
`
`I understand that Medtronic proposed the following level of ordinary
`
`skill in the art for these IPRs: a person of ordinary skill in the art (“POSITA”) at
`
`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
`
`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
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`14.
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` I have been asked to opine on the mechanism by which a
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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
`
`artery due to a guidewire engaging a tough stenosis, for example.
`
`Ex-1814 (Takahiko Suzuki, M.D.)
`http://cct.gr.jp/2003/books/bookspdf/suzuki05cii.pdf
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`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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`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”
`
`in an ostial RCA or LCA lesion.” Ex-1814.
`
`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
`
`
`1 I cite the references I discuss in this declaration according to the way they are
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`numbered in IPR2020-00126 (e.g. Ex-1010.). However, I understand that the
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`same set of exhibits was filed in each of the eleven IPRs concerning the five
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`Root patents, always retaining the same final two numbers. There are
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`several exceptions to this general rule, including at least the exhibits ending in
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`“01,” “05,” and “42;” 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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`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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`Id., Fig. 2.
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`
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`18. Suzuki and Takahashi disclose a catheter-in-catheter system that
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`improves back-up support. Takahashi teaches that the distance between the inner
`
`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.
`
`20.
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` By using a catheter-in-catheter assembly, it is possible to extend the
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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.
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`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. These mechanical properties are proportional to the moment of intertia,
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`and the construction material. Id.
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`23.
`
` The moment of inertia, 𝐼(cid:2868), of the cross section of a catheter with
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`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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`
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`𝐼(cid:2868) =
`
`𝜋(𝐷(cid:2872) − 𝑑(cid:2872))
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`64
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`24. 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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`𝐽(cid:2868)𝑐𝑎𝑡ℎ𝑒𝑡𝑒𝑟 =
`
`𝜋(𝐷(cid:2872) − 𝑑(cid:2872))
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`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. Flexural rigidity increases;
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`b. Torsional rigidity increases; and
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`c. Resistance to buckling force increases.
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`26. 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
`
`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
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`28.
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`I have been asked to opine on whether suction catheter (2) of Itou is
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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 (IPR2020-00135), 30-31, Paper 44
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`(IPR2020-00135), 11-17; Ex-2138 (IPR2020-00135), ¶¶ 138-41; Paper 44
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`(IPR2020-00126), 19-21; Paper 44 (IPR2020-00128), 19-21; Paper 44
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`(IPR2020-00132), 9-10.
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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).
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`Ex-1007, Figs. 1A-F.
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`Id., Fig. 3 (illustrating suction catheter 2, color added).
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`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 time frame, there were
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`commercially available balloon and stent catheters that could be delivered through
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`a guide catheter that had an inner diameter (“ID”) of >0.056 inches. One example
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`is the 5 Fr Heartrail catheter that has an inner diameter of 0.059 inches. Ex-1010,
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`452. Such an inner diameter can “accept normal balloons or stent delivery systems
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`less than 4.0 mm in diameter.” Id.
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`31.
`
`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 44
`
`(IPR2020-00135), 16-17; Ex-2138 (IPR2020-00135), ¶¶ 138-41; Paper 44
`
`(IPR2020-00126), 19-21; Paper 44 (IPR2020-00128), 19-21; Paper 44
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`(IPR2020-00132), 9-10. Patent Owner argues that wire-like portion 25 to catheter
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`2 partially blocks the proximal opening of catheter 2. Id. Mr. Keith argues that wire
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`25 reduces the effective size of the lumen from 0.059 inches to 0.046 inches.
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`Ex-2138 (IPR2020-00135), ¶ 141. Patent Owner argues that once suction catheter
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`2 was placed in a guide catheter, it would be impossible to advance a balloon or
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`stent into catheter 2 for delivery into the coronary vasculature.
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`34.
`
`I disagree with Mr. Keith and Patent Owner’s position.
`
`35. First, as reported in Itou’s table 1, the wire-like pushrod, 25, does
`
`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];
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`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
`
`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
`
`that balloon angioplasty catheters should have a decreasing rigidity along their
`
`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
`
`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.
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`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
`
`positioned within a guide catheter as shown in Fig. 6.
`
`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).
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`
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`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
`
`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)
`
`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.
`
`43. By the early 2000s, standard coronary stents, guidewires, balloon
`
`catheters, and stent catheters were available with an outer diameter sufficient to
`
`pass through Itou’s allegedly constricted opening of 0.046 inches. See Ex-1015,
`
`641 (“All current slotted tube designs are ‘bare mounted’ on a delivery balloon,
`
`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
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`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;
`
`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
`
`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
`
`typical in 2005-2006.
`
`46. For the reasons stated above, it is my opinion that the lumen of Itou’s
`
`suction catheter 2 is suitable for receiving a stent catheter once catheter 2 has been
`
`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
`
`is still within the guide catheter.
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`VI. Ressemann
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`A. Rationale for Modifying Embodiment 100 with Collar 2141
`
`47.
`
`I have reviewed Petitioner’s arguments regarding reasons to combine
`
`Ressemann collar 2141 with embodiment 100, as well as Teleflex’s arguments to
`
`the contrary. Paper 1 (IPR2020-00129), 45-47; Paper 44 (IPR2020-00129), 28-42;
`
`Ex-2138, ¶¶ 180-88.
`
`48.
`
`I agree that the modification to embodiment 100 of Ressemann 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.
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`Paper 1 (IPR2020-00129), 46 (citing Ex-1205, ¶ 189; Ex-1242 ¶¶ 86-87.)
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`49. As noted by Medtronic, combining Ressemann’s collar with
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`Ressemann’s embodiment 100 yields at least two inclines, labeled in the schematic
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`below.
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`17
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`Ex-1008, Fig. 1C (modified with support collar 2141).
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`50. Notably, Ressemann’s collar has more than two inclines, as shown in
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`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
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`at the proximal end (A), the transition from the concave track of the tab portion
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`and incline (B), and the incline near the distal most portion of the opening (C)).
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`51.
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`In regard to the motivations identified related to flexibility transition
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`and proximal opening reinforcement provided by collar 2141, Patent Owner argues
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`that because Ressemann’s evacuation sheath assembly 100 works without support
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`collar 2141, POSITA would have no reason to modify it to include the collar. Paper
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`44, 39. I disagree and set forth my reasons below.
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`1. Use of flexibility transition members in the art
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`52. By the relevant time frame it was well known to a POSITA that a
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`critical region where kinking and buckling can occur in coronary catheters was at
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`the interface between the stiff proximal portion and the flexible distal portion of
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`the catheter due to the change in stiffness at this interface.” Ex-1829, 2:38-49.
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`a. Goodin, U.S. Pat. No. 6,361,529
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`53. For example, Goodin teaches a rapid-exchange balloon angioplasty
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`catheter with a proximal section 20 and a distal section 30. Id., 4:26-32. Goodin
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`also teaches an improvement to the catheter in the form of a stiffness transition
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`member 50, made, for example, from stainless steel wire, or other material with
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`appropriate mechanical characteristics. Id., 6:38-41.
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`Id., Fig. 1 (annotation added).
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`54. Goodin teaches positioning member 50 in the interior of a catheter
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`shaft.
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`b. U.S. Pat. No. 5,658,251
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`55. Similarly, a patent that issued to Mr. Keith and others also teaches the
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`use of a transition member in the interior of a balloon catheter shaft to reinforce the
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`catheter’s distal end, preventing kinking or closure. Ex-1120 (“the ’251 patent”) at
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`3:16-19.
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`56. The inventors explained that the proximal hypotube section 22 of the
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`catheter was relatively stiff. The catheter’s distal section 24 includes a tubular shaft
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`23, which was more flexible than section 22. Id., 5:34-38, 6:7-13, 7:6-8. Moreover,
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`the presence of guidewire 50 within the guidewire lumen 52 meant that there were
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`relatively stiff sections at both ends of distal section 24. Id., 7:8-10.
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`“Without the transition member 25, such a configuration will tend to
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`bend or buckle in the relatively flexible area as an attempt is made to
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`advance catheter 20 through the vasculature. The responsiveness of the
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`20
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`catheter would thus be substantially diminished. Further, the catheter
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`20 might tend to kink at the transition section.”
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`Id., 7:9-14.
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`57. Similar to Goodin, the ’251 patent teaches adding a transition member
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`25 to the catheter that increases the stiffness of the distal shaft 23, but is less stiff
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`(“has less axial strength”) than the hypotube of the main shaft section 22.
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`Id., Fig. 5 (annotation added).
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`c. U.S. Pat. No. 5,156,594
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`
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`58. Those skilled in the art were also aware that transition members could
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`be added to a catheter’s exterior, instead of being embedded in the interior of a
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`catheter shaft. Again, a patent to Mr. Keith illustrates this principle. In a patent
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`disclosing an over-the-wire balloon dilatation catheter, a guide wire lumen is
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`disclosed as extending only through the distal portion of the catheter. Ex-1121.
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`59. Similar to the ’251 patent, the ’594 patent teaches a proximal shaft 22
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`that is relatively stiff, which includes a more proximal, long shaft section 64
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`(highlighted below in yellow) and a short shaft section 66 (below, orange).
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`21
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`Id., Fig. 2 (excerpted and annotation added).
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`60. The ’594 patent also teaches a distal balloon section 26 (below, pink).
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`Id.
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`61. Distal section 26 and proximal shaft 22 are joined through an
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`intermediate sleeve section 24. Id., 7:23-8:14.
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`22
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`Id., Fig. 2 (excerpted and annotation added).
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`62. The ’594 patent explains that proximal shaft 22 is relatively stiff
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`compared to the more flexible polymer intermediate sleeve section 24, and that the
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`relatively sharp transition in stiffness in the catheter structure creates two potential
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`concerns. Id., 8:52-55. First, there is the potential for the catheter to kink during
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`handling. Second, there is the potential for the distal end of the main shaft to “dig
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`in” to the guide catheter due to the lack of support from the more flexible sleeve.
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`Id., 8:52-63.
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`63. The ’594 patent teaches that a kink-resistant structure 110 may be
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`added to the outside of sleeve 24, to provide intermediate (transitory) stiffness and
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`kink-resistance between the relatively stiff main shaft and the relatively flexible
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`intermediate sleeve.
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`23
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`Id., Fig. 1.
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`64. The ’594 patent teaches that structure 110 may include coil 112,
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`which may be secured to the exterior of the sleeve by an adhesive like epoxy, and
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`further secured using a heat shrinkable sheath. Id., 9:15-20. The ’594 illustrates
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`that there were well known ways to attach additional components to catheters.
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`65. Collectively, the Goodin, ’251 and ’594 patents illustrate the
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`well-known principle that coronary catheters may be reinforced to prevent kinking
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`or buckling, in particular at areas where there is a transition in stiffness, and that
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`the reinforcement may be placed within a catheter shaft or on the exterior of the
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`catheter.
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`66. Eidenschink and Fahey also disclose the need to transition the
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`stiffness at the critical juncture between a catheter’s relatively stiff proximal
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`portion and more flexible distal portion, which is described and addressed in detail
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`in § XI, infra.
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`24
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`B.
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`Feasibility of Modifying Embodiment 100 with Collar 2141
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`67.
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`I have also been asked to opine on how a POSITA would understand
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`certain embodiments in Ressemann. In particular, for the embodiments shown in
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`Figures 1A and 1C, I have been asked to detail how POSITA would understand the
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`relative sizes of the evacuation head 132 as compared to the evacuation lumen 142,
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`and shafts 110 and 120. A reproduction of Fig. 1A is shown below.
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`
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`Ex-1008, Fig. 1A.
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`
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`68.
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`In a preferred embodiment of Ressemann, evacuation head 132 is
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`intended to be used with an 8 French guide catheter whose inner diameter is about
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`0.090 inches. Id., 10:13-17. The inner diameter of evacuation lumen 140 is
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`“approximately 0.061 inches.” Id., 10:18. The targeted outer diameter is 0.076
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`inches. Id., 10:28. Ressemann’s inflation lumen 142 (shown in cross section in Fig.
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`1D, below) is “0.005 inches at the widest portion of the crescent (vertical direction
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`in Fig. 1B).” Id., 10:21-23. I modified Fig. 1D, below, to indicate the vertical
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`dimension recited by Ressemann.
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`25
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`Id., Fig. 1D.
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`69. Ressemann does not provide a cross sectional view of shafts 110 or
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`120. Ressemann does state that shaft 110 “forms a hollow tube” preferably “made
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`of stainless steel.” Id., 10:36-37. Shaft 110 “provides fluid communication between
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`an inflation apparatus (not shown) and the intermediate and distal shaft portions
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`120, 130. Id., 10:42-44. Ressemann teaches to coat shaft 110 with “a polymer
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`sleeve or spray coating for lubricity.” Id., 10:44-46.
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`70. Shaft 120 also “forms a hollow tube” preferably “formed of
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`polyethylene or Pebax.” Ex-1008, 10:62-11:1. Shaft 120 also “provides fluid
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`communication between the proximal shaft portion 110 and distal shaft portion
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`130.” Id., 11:1-3. Shaft 120 is “secured to the proximal and distal shaft portions
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`110, 130, preferably by an overlapping weld or bond joint.”
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`71. While Ressemann does not explicitly show in its figures, POSITA
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`would understand shaft 110’s and 120’s “hollow tubes” to be circular in cross-
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`section as was common in the art when Ressemann was filed (2002). The crescent
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`shape, or D-shape of inflation lumen 142 was also a common inflation lumen
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`shape known in the art. See, e.g., Ex-1050, Fig. 5, showing a D-shape inflation
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`lumen for a rapid exchange balloon catheter.
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`72.
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`It was common in the art to join a crescent shape or D-shape inflation
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`lumen with a more proximal tube having a circular cross section. See, e.g,
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`Ex-1050. Enger illustrates a D-shaped inflation lumen 40 that “communicates”
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`with lumen 36 of stainless steel hypotube 28 having an outer diameter of 0.022
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`inches (and thus a circular cross section) and a wall thickness of about 0.003
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`inches. Id., 5:3-5; see also Ex-1050, Fig. 5. Taking the wall thickness into account,
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`the inner diameter of hypotube 28 is 0.016 inches. A POSITA would understand
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`Ressemann’s shaft 120 to be circular in cross section and in communication, and
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`therefore j