Declaration previously submitted in conjunction with
`Medtronic, Inc. and Medtronic Vascular, Inc.’s Petition
`for Inter Partes Review in IPR2020-00129, et seq.
`
`
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`Medtronic Ex. 1907
`Medtronic v. Teleflex
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`

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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.,
`
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner.
`_____________________________
`
`Case No.: IPR2020-00129
`U.S. Patent No. RE45,380
`
`DECLARATION OF RICHARD A. HILLSTEAD, PH.D., FAHA
`
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`TABLE OF CONTENTS
`
`Page
`
`I.
`Introduction ....................................................................................................... 1
`Qualifications .................................................................................................... 1
`II.
`Scope of Work ................................................................................................... 4
`III.
`The Person of Ordinary Skill in the Art ............................................................ 5
`IV.
`Overview of Ressemann and Common Teachings in the Art ........................... 6
`V.
`VI. Background on Catheter Sizes .......................................................................... 8
`VII. Overview of Itou ............................................................................................... 9
`VIII. Overview of Takahashi .................................................................................... 11
`IX. Overview of Kataishi .......................................................................................14
`X.
`Overview of Berg and Common Knowledge Related to Flexibility and
`Reinforcement .................................................................................................17
`XI. Overview of Enger ..........................................................................................25
`XII. Explicit Teachings of Ressemann ....................................................................26
`A. Ressemann discloses an evacuation sheath with flexibility that increases
`along its longitudinal axis in a proximal to distal direction. ...................26
`B. Ressemann discloses a proximal opening that includes two different
`inclined slopes. ........................................................................................30
`C. Ressemann teaches at least three regions of flexural moduli. .................38
`D. Ressemann in combination with Kataishi discloses to a POSITA a
`proximal opening with two inclined slopes. ............................................43
`E. Ressemann in combination with Enger discloses to a POSITA a proximal
`opening with two inclined slopes. ...........................................................49
`F. Ressemann could be modified for use as strictly an extension catheter
`and not as an aspiration catheter. .............................................................52
`G. Ressemann in combination with Berg discloses to a POSITA regions of
`distinct flexural moduli in which a first flexural modulus is 1,000 to
`15,000 psi, a second flexural modulus is about 2,000 to 49,000, and a
`third portion flexural modulus is about 13,000 to 49,000. ......................54
`XIII. Itou Disclosure.................................................................................................58
`A.
`Itou discloses a suction catheter 2 with flexibility that increases along its
`longitudinal axis in a proximal to distal direction. ..................................58
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`D.
`
`B.
`C.
`
`Itou’s tubular structure is reinforced. ......................................................62
`Itou discloses a suction catheter 2 with regions of distinct flexural
`moduli in which the flexural modulus increases from the distal tip (22) to
`the reinforced portion (21 and 232) to the solid wire-like portion (25). .65
`Itou in combination with Kataishi discloses to a POSITA a proximal
`opening with two inclined slopes. ...........................................................69
`E. Modifying Itou, in combination Berg’s plurality of segments of selected
`flexural modulus in the device’s shaft, to have regions of distinct flexural
`moduli in which the first flexural modulus is 1,000 to 15,000 psi, a
`second flexural modulus is about 2,000 to 49,000 psi, and a third portion
`flexural modulus that is about 13,000 to 49,000 psi. ..............................73
`XIV. Concluding Remarks .......................................................................................77
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`TABLE OF EXHIBITS
`
`1215
`
`1224
`
`No.
`1201
`1207
`1208
`1209
`1210
`
`Description
`U.S. Patent No. RE45,380 (“the ’380 patent”)
`U.S. Patent No. 7,736,355 (“Itou”)
`U.S. Patent No. 7,604,612 (“Ressemann”)
`U.S. Patent No. 5,439,445 (“Kontos”)
`New Method to Increase a Backup Support of a 6 French Guiding
`Coronary Catheter, Catheterization and Cardiovascular Interventions
`63: 452-456 (2004) (“Takahashi”)
`Excerpt from Grossman’s Cardiac Catheterization, Angiography, and
`Intervention (6th edition) (2000) (chapters 1, 4, 11, 23-25).
`Boston Scientific, Summary of Safety and Effectiveness Data,
`TAXUS™ Express2™ Drug-Eluting Coronary Stent System (March
`4, 2004)
`U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`U.S. Patent No. 5,489,278 (“Abrahamson”)
`The sliding rail system (monorail): description of a new technique
`for intravascular instrumentation and its application to coronary
`angioplasty, Z. Kardio. 76:Supp. 6, 119-122 (1987) (“Bonzel”)
`U.S. Publication Application No. 2004/0236215 (Mihara)
`U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`Excerpt of McGraw-Hill Dictionary of Scientific and Technical
`Terms (5th edition) (1994) (defining “flexural modulus”)
`U.S. Patent No. 5,961,510 (“Fugoso”)
`1244
`U.S. Patent No. 6,042,578 (“Dinh”)
`1246
`1247 WO 97/37713 (“Truckai”)
`1248
`Terumo Heartrail II product literature
`1250
`U.S. Patent No. 5,980,486 (“Enger”)
`1251
`U.S. Patent No. 5,911,715 (“Berg”)
`
`1225
`1226
`1232
`
`1233
`1235
`1240
`
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`No.
`1255
`
`1261
`1262
`
`1275
`
`1279
`
`Description
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`U.S. Patent No. 5,690,613 (“Verbeek”)
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`Excerpt from Plaintiff’s infringement allegations in Vascular
`Solutions, LLC. v. Medtronic, Inc., D. Minn., No. 19-cv-01760
`(October 11, 2019), D.I. 1-14.
`Complaint in Vascular Solutions, LLC. v. Medtronic, Inc., D. Minn.,
`No. 19-cv-01760 (October 11, 2019), D.I. 1-14.
`
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`I.
`
`Introduction
`1.
`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
`
`Inc. and Medtronic Vascular, Inc. (“Medtronic”) as an independent expert to
`
`provide my opinion on the disclosures of certain patents.
`
`2.
`
`I am informed that Medtronic intends to use my opinion in support of
`
`its petition to the Patent Trial and Appeal Board (“PTAB”) to institute an Inter
`
`Partes Review (“IPR”) of U.S. Patent No. RE45,380.
`
`3.
`
`I make this declaration based on my personal education, experience,
`
`and knowledge in medical device product development since 1987.
`
`II. Qualifications
`4.
`My curriculum vitae is submitted as Ex. 1243.
`
`5.
`
`I have been actively involved in the design and development of
`
`medical devices for more than thirty years. I held several progressive, Product
`
`Research and Development positions with Cordis Corporation (J&J) from 1987 to
`
`1993 where I was responsible for the design and development of numerous
`
`vascular intervention devices including stents and angioplasty balloon catheters. I
`
`pioneered device development in the Cordis Coronary Stent program as a Senior
`
`Corporate Research Engineer. During my tenure at Cordis, I also held the position
`
`of Senior Engineer, Custom Products, where I was responsible for designing a
`
`wide variety of customized catheters and devices for individual physicians.
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`6.
`
`From 1993 until 1999, I directed new technology development for
`
`Novoste Corporation in Georgia, primarily focusing on intravascular
`
`brachytherapy and catheter based delivery systems for the treatment of coronary
`
`restenosis following angioplasty and stenting.
`
`7.
`
`In 1999, I became a founding member of The Innovation Factory, a
`
`private medical device incubator in Duluth, GA. At The Innovation Factory, I
`
`served as Chief Science Officer and was primarily responsible for early clinical
`
`investigations, and overall R&D in a wide variety of Life Science ventures.
`
`8.
`
`I was a principal partner and founding member in Accuitive Medical
`
`Ventures I and II (2004 – 2008). Accuitive Medical Ventures is a $225M venture
`
`capital fund focused entirely on growing early stage medical device companies into
`
`attractive candidates for acquisition. In 2008, I joined another medical device
`
`venture fund, Georgia Venture Partners (GVP) where I remain a partner today.
`
`9.
`
`I have managed numerous, diverse, multi-disciplinary development
`
`teams from product concept through clinical approval to sales release. I am a
`
`frequent speaker on the importance of innovation and intellectual property creation
`
`and capture as it relates to the entrepreneurial process in the medical device
`
`industry at conferences and scientific sessions.
`
`10. Currently, I am CEO of Richard A. Hillstead Inc., a medical device
`
`development and entrepreneurship consulting firm located near Atlanta, GA. I am
`
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`also the current Chairman and former CEO of Biofisica Inc., a Georgia wound
`
`healing device company. I am a past Chairman and co-founder of Cerebral
`
`Vascular Applications, Inc. (CVA), a Georgia company dedicated to reducing the
`
`incidence of stroke through closure of the atrial appendage of the heart. I am a
`
`former member of the Emory University New Technology Advisory Board where I
`
`participated in reviewing promising new Medical Device Technologies and
`
`recommended development strategies.
`
`11.
`
`I was the 2019 recipient of the Georgia BIO Golden Helix Award for
`
`Industry Growth, the highest award bestowed in the state of Georgia for medical
`
`device design, development, and entrepreneurship.
`
`12.
`
`I am named inventor on approximately eighty issued U.S. patents and
`
`pending applications as well as dozens of international patents. My patents pertain
`
`to medical device design, and a majority of these patents relate specifically to
`
`catheter design. Globally, my patents and applications have been cited by others
`
`over 8000 times.
`
`13.
`
`In 2012 and 2013, I served as an Entrepreneur in Residence to the
`
`United States Food and Drug Administration.
`
`14.
`
`I am a Fellow in the American Heart Association (FAHA) on the
`
`Council of Clinical Cardiology; Fellow on the Council on Lifestyle and
`
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`Cardiometabolic Health; and am a current member of the Stroke Council and
`
`Council on Cardiopulmonary Resuscitation.
`
`15.
`
`I have no financial interest in Medtronic. I similarly have no financial
`
`interest in the asserted patents, and have had no contact with the named inventors
`
`of the asserted patent.
`
`III.
`
`Scope of Work
`16.
`I have been asked to review the ’380 patent and opine on the level of
`
`ordinary skill in the art as of May 3, 2006.
`
`17.
`
`I have additionally been asked to consider and provide my opinions
`
`on disclosures in the following references:
`
`1.
`
`2.
`3.
`
`4.
`
`5.
`6.
`
`U.S. Pat. No. 7,604,612 to Ressemann (“Ressemann”) (Ex.
`1208);
`U.S. Pat. No. 7,736,355 (“Itou”) (Ex. 1207);
`“New Method to Increase a Backup Support of a 6 French
`Guiding Coronary Catheter,” Catheterization and
`Cardiovascular Interventions, 63:452-456 to Takahashi
`(“Takahashi”) (Ex. 1210);
`U.S. Pat. Pub. No. 2005/0015073 to Kataishi et al., (“Kataishi”)
`(Ex. 1225);
`U.S. Pat. No. 5,911,715 to Berg (“Berg”) (Ex. 1251); and
`U.S. Pat. No. 5,980,486 to Enger (“Enger”) (Ex. 1250).
`
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`IV. The Person of Ordinary Skill in the Art
`18.
`I am not a lawyer and have been informed by counsel of the legal
`
`standards set forth herein. I have also been informed by counsel of factors that may
`
`be considered in determining the level of ordinary skill in the art include (a) the
`
`educational level of the inventor; (b) the type of problem encountered in the art; (c)
`
`prior art solutions to those problems; (d) the rapidity with which inventions are
`
`made; (e) sophistication of the technology; and (f) the educational level of those
`
`working in the field.
`
`19.
`
`I have reviewed the ’380 patent. For the ’380 patent, a person of
`
`ordinary skill in the art (“POSITA”) at the time of the alleged invention (May 3,
`
`2006) would have had (a) a medical degree; (b) completed a coronary intervention
`
`training program, and (c) experience working as an interventional cardiologist.
`
`Alternatively, a POSITA would have: (a) had an undergraduate degree in
`
`engineering, such as mechanical or biomedical engineering; and (b) had three years
`
`of experience designing medical devices, including catheters or catheter-
`
`deployable devices. Extensive experience and technical training might substitute
`
`for education, and advanced degrees might substitute for experience. Additionally,
`
`a POSITA with a medical degree may have 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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`V. Overview of Ressemann and Common Teachings in the Art
`20. U.S. Pat. No. 7,604,612 to Ressemann (“Ressemann”) was filed
`
`August 9, 2002 and issued October 20, 2009.
`
`21. Ressemann teaches “a partial length evacuation sheath” used to
`
`“evacuat[e] emboli, particulate matter, and other debris from a blood vessel.” Ex.
`
`1208, 3:59-61; 5:65-67. The evacuation sheath of Ressemann is intended to be
`
`deployed with the aid of a guide catheter that is positioned within the ostium of a
`
`coronary artery, while the evacuation sheath may be advanced through the guide
`
`catheter and beyond a major side branch of a target vessel. Ex. 1208, 12:26-30.
`
`22. Ressemann’s evacuation sheath assembly is for aspirating embolic
`
`material (id., Abstract, 12:9-13:34), and for stent or balloon delivery. Id., 6:25-34,
`
`12:3-8.
`
`23. The evacuation sheath includes a distal evacuation head 132 and a
`
`shaft portions (including proximal shaft 110, distal shaft 120). Id., 6:19-20, 10:36,
`
`10:60-62, Figs. 1A, 1C, 11A. The head is “preferably made of a relatively flexible
`
`polymer such as low-density polyethylene, polyurethane, or low durometer
`
`Pebax® material.” Id., 6:36-39. The head 132 is illustrated below in pink.
`
`24. Ressemann teaches that a coil 139 can be embedded into the tube to
`
`provide kink resistance. Id., 6:67-7: 7. Ressemann describes that the distal end of
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`the tube is “angled” to impart more flexibility at the distal tube’s end. See id., 7:48-
`
`51.
`
`Ex. 1208, Fig. 1C (color added).
`
`25. Ressemann also teaches deploying a stent through evacuation head
`
`132, as shown below in Figure 6E, excerpted below.
`
`
`
`
`
`Ex. 1208, Figure 6E (color and annotations added).
`
`
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`26. Ressemann also teaches to angle the proximal opening of its
`
`evacuation head. Ressemann teaches that the angle at 140a, (see figure above),
`
`allows for smoother passage of therapeutic devices through the lumen 140 and the
`
`larger area of an angled opening (as opposed to the area of an opening formed by a
`
`vertical end to lumen 140) allows for larger material to pass through the lumen
`
`more smoothly. Ressemann states:
`
`the evacuation
`The proximal and distal ends 140a, 140b of
`lumen 140 are preferably angled to allow for smoother passage of the
`evacuation sheath assembly 100 through a guide catheter, and into a
`blood vessel, and to facilitate smoother passage of other therapeutic
`devices through the evacuation lumen 140 of the evacuation head 132.
`The larger area of the angled open ends also allows for larger
`deformable particulate matter to pass through the lumen more
`smoothly.
`Ex. 1208, 6:52-60.
`VI. Background on Catheter Sizes
`27. Clearly, Ressemann’s evacuation head is sized such that a balloon
`
`deliverable stent can be passed through its lumen. See Ex. 1208, Figs. 6E-F. To
`
`understand more about the sizing of catheters and devices, I provide a brief
`
`background on the size of catheters and interventional devices. The French gauge
`
`size is a quantitative measure common in catheter design that was developed in the
`
`19th century. Ex. 1262, 545. The “French size” (commonly abbreviated as “Fr”) is
`
`a standard unit of measure of the diameter of a catheter. One French equals 1/3
`
`mm. Id.
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`28. A guide catheter must be small enough to fit in the artery of the
`
`patient yet big enough to accommodate interventional devices such as balloon
`
`catheters, and stents. As of May 3, 2006, guide catheters generally ranged in size
`
`from 5 French to 8 French. See Ex. 1210, 453-54; Ex. 1215, 548-49.
`
`29. For example, as described by an article authored by Takahashi, the 5
`
`Fr Heartrail catheter had an inner diameter of 0.059 inches (1.50 mm) (see Ex.
`
`1248) and could accept “normal balloons or stent delivery systems less than 4.0
`
`mm in diameter.” Ex. 1210, 452. The 4.0 mm diameter notation of the balloon or
`
`stent refers to its fully expanded size and not its size prior to inflation or expansion.
`
`See Ex. 1224 (describing the Taxus rapid exchange delivered stent for use with a 5
`
`Fr guide catheter (guide catheter inner diameter equal to or greater than 0.058
`
`inches)).
`
`VII. Overview of Itou
`30. U.S. Patent No. 7,736,355 to Itou (“Itou”) was filed on September 23,
`
`2005 and issued June 15, 2010.
`
`31.
`
`Itou discloses a suction catheter, 2, (shown in blue below) that extends
`
`beyond the distal end of a guide catheter 1 to suck thrombi or emboli from the
`
`coronary arteries of a patient. See Ex. 1207, Abstract.
`
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`Ex. 1207, Fig. 5 (color added).
`
`32. Figure 6 of Itou, reproduced below, shows a guide catheter placed at
`
`the ostium of the coronary artery with the suction catheter extending beyond the
`
`distal end of guide catheter and into the coronary artery and near a target location
`
`80 for foreign matter such as emboli or thrombus.
`
`Ex. 1207, Fig. 6 (color added).
`
`
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`33.
`
`Itou teaches that the purpose of the suction catheter is to reach foreign
`
`matter “positioned at a deep location in a coronary artery.” Ex. 1207, 2:1-2.
`
`34. With reference to Itou’s figure 3, shown below, the structure of Itou’s
`
`suction catheter 2 is characterized by a soft distal tip portion 22 (pink), a tubular
`
`portion 21 reinforced with wire 211, and a wire-like portion 25. See Ex. 1207,
`
`3:46-63.
`
`
`
`Ex. 1207, Fig. 3 (color added).
`
`35. The proximal opening of Itou’s suction catheter 2 is characterized by
`
`an angled opening. An angled opening was a common feature of rapid-exchange-
`
`style catheters by May 3, 2006. See, e.g., Ex. 1207, Fig. 1B; Ex. 1208, Fig. 1A; Ex.
`
`1261, Fig. 1B; Ex. 1232, 120; Ex. 1250, Fig. 1.
`
`VIII. Overview of Takahashi
`36. The article “New Method to Increase a Backup Support of a 6 French
`
`Guiding Coronary Catheter” by Takahashi et al. (“Takahashi”), published in
`
`Catheterization and Cardiovascular Interventions in 2004 and describes a 5 Fr in 6
`
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`Fr mother-and-child system that provides greater backup support than a 7 Fr guide
`
`catheter.1 Ex. 1210.
`
`37. Before describing the teachings of Takahashi, I provide a brief
`
`background on the size of catheters and interventional devices. The French gauge
`
`size is a quantitative measure common in catheter design that was developed in the
`
`19th century. Ex. 1262, 545. The “French size” (commonly abbreviated as “Fr”) is
`
`a standard unit of measure of the diameter of a catheter. One French equals 1/3
`
`mm. Ex. 1262, 545.
`
`38. A guide catheter must be small enough to fit in the artery of the
`
`patient yet big enough to accommodate interventional devices such as balloon
`
`catheters, and stents. As of May 3, 2006, guide catheters generally ranged in size
`
`from 5 French to 8 French. See Ex. 1210, 453-54; Ex. 1215, 548-49.
`
`39. For example, as described by Takahashi, the 5 Fr Heartrail catheter
`
`had an inner diameter of 0.059 inches (1.50 mm) (see Ex. 1248) and could accept
`
`“normal balloons or stent delivery systems less than 4.0 mm in diameter.” (Ex.
`
`1210 at 452.) (The 4.0 mm diameter notation of the balloon or stent refers to its
`
`fully expanded size and not its size prior to inflation or expansion.) (See also Ex.
`
`1224, which describes the Taxus rapid exchange delivered stent for use with a 5 Fr
`
`1 Vol. 63, pages 452-456.
`
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`guide catheter (guide catheter inner diameter equal to or greater than 0.058
`
`inches).)
`
`40. Takahashi teaches inserting a 5 Fr guiding catheter with an inner
`
`lumen size of 0.059 inches into a 6 Fr guiding catheter with an inner lumen size of
`
`0.071 inches (at “B,” below). Ex. 1210 at 452, 454. The difference between the
`
`inner lumen diameters of the two guiding catheters is 0.012 inches (0.30 mm),
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`which is not more than one French size2 in difference. Id.
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`41. Once the 6 Fr guiding catheter is placed at the ostia of the coronary
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`artery (“E,” below), Takahashi teaches to extend the 5 Fr guiding catheter beyond
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`the distal end of the 6 Fr guiding catheter and into the coronary artery. Ex. 1210,
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`454. Then, Takahashi places the balloon at the lesion with the advantage of the
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`additional backup support provided by the extension of the 5 Fr guiding catheter.
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`Id.
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`2 One French equals 1/3 of a millimeter or 0.33 mm.
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`IX. Overview of Kataishi
`42. Kataishi is a U.S. Patent Application published on January 20, 2005 as
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`U.S. Pub. No. 2005/0015073.
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`43. Kataishi discloses a suction catheter for removing a thrombus from a
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`coronary artery. Ex. 1225, [0001]. It teaches a distal opening designed, in part, to
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`improve the catheter’s “crossing ability,” which is its ability to smoothly reach a
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`desired target site. Id., Abstract, [0001].
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`A thrombus suction catheter which is a tube having a distal end opening
`formed by an angled cut surface. In the distal end opening, at least a
`part on the proximal end side of the cut surface is formed in a concave
`shape in an angled direction, and the distal end side of the cut surface
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`is formed to be flat and flexible. With the distal end configuration,
`suction and crossing are significantly improved.
`Ex. 1225, Abstract.
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`44. Figure 12 of Kataishi is a schematic of this distal opening with
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`superior “crossing ability.”
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`
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`Ex. 1225, Fig. 12.
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`45.
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`In addition to providing flexibility, the shape of the catheter’s distal
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`opening improves its ability to suction thrombi, id., Abstract, [0026]-[0027], Fig.
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`10, which corresponds to loading a thrombus into the catheter’s distal end. The
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`reason for this improved ability to load matter is the increased surface area formed
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`by a two incline opening.
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`Ex. 1225, Fig. 10 (annotation added).
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`46. The distal end has an “angled cut surface, in which at least a part on
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`the proximal end side of the angled surface is formed in a concave shape in the
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`angled direction and the distal end side of the cut surface is formed to be flat and
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`flexible . . . .” Id., [0010]. The catheter tip is shown below.
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`
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`Ex. 1225, Fig. 2 (annotation added).
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`47. Cut surface 16 has a concave shape 161 that is closest to the fully
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`circumferential portion of catheter lumen 11. The concave shape is adjacent “ledge
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`surface 164,” which is parallel to the catheter’s longitudinal axis. Moving distally,
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`“cut surface 163 defining an angle with the longitudinal axis of the catheter.” Id.,
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`[0027].
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`48. Kataishi teaches that its distal end configuration significantly
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`improves crossing, stating:
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`In the distal end opening 12, at least a part 161 on the proximal end side
`of the cut surface 16 is formed in a concave shape in the angled
`direction, and the distal end side 162 of the cut surface 16 is formed to
`be flat and flexible and to neck down at its tip. With this distal end
`configuration, suction and crossing are significantly improved.
`Ex. 1225, [0026].
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`49. This “significantly improved crossing” is born out in a study reported
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`by Sakurada et al. in Catheterization and Cardiovascular Interventions. See Ex.
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`1255 (“Sakurada”). Here, Sakurada reports quantitative data showing that
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`Kataishi’s distal opening design had the best ability to pass bends as compared to
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`two known products, the PercuSurge and Thrombuster catheters. Id., at 302.
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`X. Overview of Berg and Common Knowledge Related to Flexibility and
`Reinforcement
`50. U.S. Pat. No. 5,911,715 to Berg (“Berg”) teaches a guide catheter used
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`for placing interventional cardiology devices. Ex. 1251. Specifically, Berg teaches
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`a guide catheter in which regions of the guide catheter are designed with specific
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`flexibilities in order to improve performance of the guide catheter. Id., 1:21-25.
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`51. To aid in my discussion of Berg, it’s important to understand the
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`criteria that must be met by any device that is required to be inserted into the
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`vasculature and traverse the anatomy from the groin to the heart (or from the wrist
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`to the heart, in the case of radial artery access).
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`1.
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`First, the device must be flexible enough to traverse the curves
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`2.
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`3.
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`and bends of the patient’s vasculature.
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`Second, the device must not damage the vasculature.
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`Third, the device must be rigid enough or “pushable” so that it
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`doesn’t significantly compress or stretch during placement and
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`is “steerable” enough to navigate tortuous vasculature.
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`52. By May 3, 2006, it was well known that a balance between flexibility,
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`rigidity, and atraumatic properties must be maintained when designing a PTCA
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`catheter. Numerous teachings of this balance of features existed in the art at this
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`time. Ex. 1215, 549; Ex. 1251, 2:35-46; see also, Ex. 1207; Ex. 1208; and Ex.
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`1209.
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`53. For example, it was known in the art that the distal tip of a catheter
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`should be soft. Guide catheters, for example, included “a very soft material in the
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`most distal 2 mm of the catheter to reduce the chance of vessel trauma.” Ex. 1215,
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`549. Similarly, the distal end of PTCA catheters were “made to be extremely soft
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`and flexible so as to facilitate its passage through tortuosities and restrictions in the
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`vascular system.” Ex. 1209, 1:30-34. And support catheters designed to extend
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`beyond the distal tip of a guide catheter were also designed to “have a soft tip.” Id.,
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`2:51-54, 4:5-7. For example, as Kontos describes, a soft tip could be made of a soft
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`plastic, such as “a copolymer of polyethylene and ethyl-vinylalcohol (EVA).” Id.,
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`4:10-11.3
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`54. More generally, it was known in the art that in order for coronary
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`catheters to safely traverse the vasculature, the preferred material used to form the
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`catheter should either be a polymer or a material coated with a polymer See, e.g.,
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`Ex. 1207, 3:30-37; 3:50-58; Ex. 1208, 6:36-42; 6:66-7:14. Most commonly around
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`2000, guide catheters were formed of either polyethylene (Cook Inc.,
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`Bloomington, IN) or polyurethane (Cordis Corporation, Miami, Fl., and USCI,
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`Billerica, MA) and contain either steel braid, nylon, or other reinforcing materials
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`within the catheter wall. Ex. 1215, 214. Occasionally reference to “resin” in the
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`literature in conjunction with catheter materials and their manufacture means that
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`the final catheter material is formed of a polymer. Resins are the raw materials that
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`3 A POSITA would appreciate that in this case patentee has acted as his own
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`lexicographer as the common shorthand for ethylene vinyl alcohol is EVOH, while
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`EVA typically refers to ethylene vinyl acetate.
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`are used to form the final polymer. 4 Colloquially in the catheter arts, reference to a
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`“resin” can mean that the catheter is formed of a polymer. See, e.g., Ex. 1207,
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`3:30-37; 3:50-58.
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`55. The way in which scientists and engineers quantitatively measure the
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`relatively rigidity and flexibility of catheter is by determining their flexural
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`modulus. Flexural modulus is a material property that expresses the tendency of a
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`material to resist flexure (otherwise known as bending). See Ex. 1240, 772. A
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`material with a higher flexural modulus is less flexible than a material with a lower
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`flexural modulus.
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`56.
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`It was known in the art to design catheters and guidewires with
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`varying flexibility and thus regions that varied in their flexural modulus. See, e.g.,
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`Ex. 1215, 549, 551; Ex. 1251, 13:66-14:67. It was standard, though, to design
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`catheters so that they were more flexible at their distal ends, and increased in
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`rigidity moving proximally.
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`57.
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`Just one example is taught by Berg (Ex. 1251) and is illustrated in Fig.
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`19 of Berg, excerpted below.
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`4 See https://www.ptonline.com/knowledgecenter/profile-extrusion/glossary-of-
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`terms. Last accessed Oct. 11, 2019. While this reference is from present day, the
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`meaning of resin has not changed since May 3, 2006.
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