Declaration previously submitted in conjunction with
`Medtronic, Inc. and Medtronic Vascular, Inc.’s Petition
`for Inter Partes Review in IPR2020-00137, et seq.
`
`
`
`
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`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.: IPR2020-00137
`U.S. Patent No: RE47,379
`
`
`
`DECLARATION OF RICHARD A. HILLSTEAD, PH.D., FAHA
`
`
`
`
`
`Page 1
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`
`TABLE OF CONTENTS
`
`I.
`INTRODUCTION ........................................................................................... 1
`II. QUALIFICATIONS ........................................................................................ 1
`III. SCOPE OF WORK ......................................................................................... 4
`IV. THE PERSON OF ORDINARY SKILL IN THE ART ............................... 5
`V. OVERVIEW OF ITOU AND COMMON TEACHINGS IN THE
`ART ................................................................................................................... 6
`VI. OVERVIEW OF RESSEMANN AND COMMON TEACHINGS
`IN THE ART ..................................................................................................16
`VII. OVERVIEW OF KATAISHI ........................................................................19
`VIII. OVERVIEW OF ENGER .............................................................................22
`IX. EXPLICIT TEACHINGS OF ITOU ...........................................................23
`Itou’s wire-like portion 25 and proximal tip 23 are more rigid
`
`A.
`B.
`C.
`D.
`E.
`F.
`
`Itou’s obliquely cut metal pipe has a flexural modulus greater
`
`Itou includes reinforcement by a metal wire that is encased in a
`
`Itou discloses that the flexible tip 22 includes covering a marker
`
`along a longitudinal axis than tip 22 .....................................................23
`than the flexural modulus of tubular structure 21 .................................26
`polymer .................................................................................................28
`Itou discloses to line its lumen with polytetrafluoroethylene ...............29
`band with a polymer or elastomeric material ........................................30
`wire-like portion 25 ...............................................................................31
`
`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 & 232) to the solid
`
`X.
`
`XI.
`
`ITOU IN COMBINATION WITH RESSEMANN’S SUPPORT
`COLLAR YIELDS A PROXIMAL OPENING WITH TWO
`INCLINES AND A CONCAVE TRACK.....................................................35
`ITOU IN VIEW OF THE COMMON KNOWLEDGE OF A
`POSITA WOULD DESIGN ITOU’S REINFORCED SEGMENT
`IN A RANGE OF 20 TO 30 CM. ..................................................................46
`
`i
`
`Page 2
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`XII. ITOU IN COMBINATION WITH KATAISHI DISCLOSES TO A
`POSITA A PROXIMAL OPENING WITH TWO INCLINED
`SLOPES ..........................................................................................................49
`XIII. ITOU IN COMBINATION WITH ENGER DISCLOSES TO A
`POSITA A PROXIMAL OPENING WITH TWO INCLINED
`SLOPES ..........................................................................................................52
`CONCLUDING REMARKS ..................................................................................56
`
`
`
`
`
`
`
`
`
`ii
`
`Page 3
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`
`TABLE OF EXHIBITS
`
`
`Exhibit Description
`1001
`U.S. Patent No. RE45,380 (“the ’380 patent”)
`
`1005
`
`1007
`
`1008
`
`1009
`
`1015
`
`1025
`
`1032
`
`1033
`
`1035
`
`1040
`
`Declaration of Doctor Stephen JD Brecker, M.D.
`
`U.S. Patent No. 7,736,355 (“Itou”)
`
`U.S. Patent No. 7,604,612 (“Ressemann”)
`
`U.S. Patent No. 5,439,445 (“Kontos”)
`
`Excerpt from Grossman’s Cardiac Catheterization, Angiography, and
`Intervention (6th edition) (2000) (chapters 1, 4, 11, 23-25).
`
`U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`
`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”)
`
`1046
`
`U.S. Patent No. 6,042,578 (“Dinh”)
`
`1047 WO 97/37713 (“Truckai”)
`
`1050
`
`1051
`
`1055
`
`
`
`U.S. Patent No. 5,980,486 (“Enger”)
`
`U.S. Patent No. 5,911,715 (“Berg”)
`
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”).
`
`iii
`
`Page 4
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`
`Exhibit Description
`1061
`U.S. Patent No. 5,690,613 (“Verbeek”)
`
`1075
`
`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.
`
`1079
`
`Complaint in Vascular Solutions, LLC. v. Medtronic, Inc., D. Minn.,
`No. 19-cv-01760 (October 11, 2019), D.I. 1-14.
`
`
`
`iv
`
`Page 5
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`
`I.
`
`Introduction
`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
`1.
`
`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. RE47,379.
`
`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. 1042.
`
`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
`
`
`
`1
`
`Page 6
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`of Senior Engineer, Custom Products, where I was responsible for designing a
`
`wide variety of customized catheters and devices for individual physicians.
`
`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.
`
`
`
`2
`
`Page 7
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`10. Currently, I am the CEO of Richard A. Hillstead Inc., a medical
`
`device development and entrepreneurship consulting firm located near Atlanta,
`
`GA. I am 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 the 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 related
`
`specifically to catheter design. My patents and patent publications have been
`
`cited, globally, over 8,000 times.
`
`13.
`
`In 2012 and 2013, I served as an Entrepreneur in Residence to the
`
`United States Food and Drug Administration.
`
`
`
`3
`
`Page 8
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`I am a Fellow in the American Heart Association (FAHA) on the
`14.
`
`Council of Clinical Cardiology; Fellow on the Council on Lifestyle and
`
`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
`I have been asked to review the ’379 patent and opine on the level of
`16.
`
`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.
`
`U.S. Pat. No. 7,736,355 to Itou (“Itou”) (Ex. 1007);
`
`U.S. Pat. No. 7,604,612 to Ressemann (“Ressemann”)
`
`(Ex. 1008);
`
`3.
`
`U.S. Pat. Pub. No. 2005/0015073 to Kataishi et. al.,
`
`(“Kataishi”) (Ex. 1025); and
`
`4.
`
`U.S. Pat. No. 5,980,486 to Enger (“Enger”) (Ex. 1050).
`
`
`
`4
`
`Page 9
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`IV. THE PERSON OF ORDINARY SKILL IN THE ART
` I am not a lawyer and have been informed by counsel of the legal
`18.
`
`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 ’379 patent. For the ’379 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 had (a) an undergraduate degree in
`
`engineering, such as mechanical or biomedical engineering; and (b) 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.
`
`
`
`5
`
`Page 10
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`V. Overview of Itou and Common Teachings in the Art
`
`
`20. U.S. Pat. No. 7,736,355 to Itou (“Itou”) was filed on September 23,
`
`2005 and issued June 15, 2010.
`
`21.
`
`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. 1007, Abstract.
`
`
`
`Ex. 1007, Fig. 5 (color added).
`
`22. 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.
`
`
`
`6
`
`Page 11
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`
`
`
`Ex. 1007, Fig. 6 (color added).
`
`23.
`
`Itou teaches that the purpose of the suction catheter is to reach foreign
`
`matter “positioned at a deep location in a coronary artery.” Ex. 1007, 1:66-2:5.
`
`24. 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. 1007,
`
`3:46-63.
`
`
`
`7
`
`Page 12
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`
`
`
`Ex. 1007, Fig. 3 (color added).
`
`25.
`
`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. 1007, Fig. 1B; Ex. 1008, Fig. 1A;
`
`Ex. 1061, Fig. 1B; Ex. 1032, 120; Ex. 1050, Fig. 1.)
`
`26.
`
`Itou discloses its suction catheter (2) “includes an inner layer 210
`
`made of a resin material having a sliding property such as a fluorocarbon resin
`
`represented by PTFE.” Ex-1007, 3:50-58. PTFE is an acronym for
`
`“polytetrafluoroethylene,” which is also known as Teflon®.
`
`27. As stated above, Itou discloses that its suction catheter 2 is reinforced
`
`with wire, while its most distal portion 22 is “soft,” and the proximal portion is
`
`formed of a wire-like portion 25. Ex. 1007, 2:12-21; 3:47-50. These regions vary
`
`in their flexibility and Itou’s teaching is an example of the well-known practice of
`
`designing catheters that can be inserted into the vasculature and traverse the
`
`
`
`8
`
`Page 13
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`anatomy from the groin to the heart (or from the wrist to the heart, in the case of
`
`radial artery access). The criteria for such catheters include:
`
`1.
`
`First, the device must be flexible enough to traverse the curves
`
`and bends of the patient’s vasculature.
`
`2.
`
`3.
`
`Second, the device must not damage the vasculature.
`
`Third, the device must be rigid enough or “pushable” so that it
`
`does not significantly compress or stretch during placement and is
`
`“steerable” enough to navigate tortuous vasculature.
`
`28. By May 3, 2006, it was well known that a balance between flexibility,
`
`rigidity, and atraumatic properties must be maintained when designing a PTCA
`
`catheter. (PTCA stands for: percutaneous transluminal coronary angioplasty.)
`
`Numerous teachings of this balance of features existed in the art at this time.
`
`Ex. 1015, 549; Ex. 1051, 2:35-46; see generally, Ex. 1007; Ex. 1008; and
`
`Ex. 1009.)
`
`29. For example, it was known in the art that the distal tip of a catheter
`
`should be soft. Guide catheters, for example, included “a very soft material in the
`
`most distal 2 mm of the catheter to reduce the chance of vessel trauma.” Ex. 1015,
`
`549. Similarly, the distal end of PTCA catheters were “made to be extremely soft
`
`and flexible so as to facilitate its passage through tortuosities and restrictions in
`
`the vascular system.” Ex. 1009, 1:30-33. In addition, support catheters designed to
`
`
`
`9
`
`Page 14
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`extend beyond the distal tip of a guide catheter were also designed to “have a soft
`
`tip.” Ex. 1009, 2:51-54, 4:5-7. For example, as Kontos describes, a soft tip could
`
`be made of a soft plastic, such as “a copolymer of polyethylene and ethyl-
`
`vinylalcohol (EVA).” Id., 4:7-11. 1
`
`30. More generally, it was known in the art that in order for coronary
`
`catheters to traverse safely the vasculature, the preferred material used to form the
`
`catheter should either be a polymer or a material coated with a polymer. See, e.g.,
`
`Ex. 1007, 3:30-37, 3:50-58; Ex. 1008, 6:37-42, 6:63-67. Most commonly around
`
`2000, guide catheters were formed of either polyethylene (Cook Inc.,
`
`Bloomington, IN) or polyurethane (Cordis Corporation, Miami, Fl., and USCI,
`
`Billerica, MA) and contained either steel braid, nylon, or other reinforcing
`
`materials within the catheter wall. Ex. 1015, 214. Occasional reference to “resin”
`
`in the literature in conjunction with catheter materials and their manufacture
`
`means that the final catheter material is formed of a polymer. Resins are the raw
`
`
`1 POSITA would appreciate that in this case patentee has acted as his own
`
`lexicographer as the common shorthand for ethylene vinyl alcohol is EVOH, while
`
`EVA typically refers to ethylene vinyl acetate.
`
`
`
`10
`
`Page 15
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`materials that are used to form the final polymer. 2 Colloquially in the catheter
`
`arts, reference to a “resin” can mean that the catheter is formed of a polymer. See,
`
`e.g., Ex. 1007, 3:30-37, 3:50-58.
`
`31. The way in which scientists and engineers quantitatively measure the
`
`relative rigidity and flexibility of catheters is by determining their flexural
`
`modulus. Flexural modulus is a material property that expresses “[a] measure of
`
`resistance…to bending.” Ex. 1040, 772. In other words, flexural modulus means
`
`the tendency of a material to resist flexure (otherwise known as bending). See
`
`Ex. 1040, 772. Use of the term “flexural modulus” was known and established in
`
`the art by 2006. Moreover, when referring to relative rigidities of devices that
`
`pertain to PTCA, a POSITA would understand rigidity to refer to the extent to
`
`which a device or component can be flexed or bent in a lateral direction.
`
`32.
`
`It was known in the art to design catheters and guidewires with
`
`varying flexibility and regions that varied in their flexural modulus. See, e.g.,
`
`Ex. 1015, 549, 551; Ex. 1051, 13:66-14:67.) It was standard to design catheters so
`
`
`2 See “Resin,” Plastics Technology,
`
`https://www.ptonline.com/knowledgecenter/profile-extrusion/glossary-of-terms
`
`(last accessed Oct. 11, 2019). While this reference is from present day, the meaning
`
`of resin has not changed since May 3, 2006.
`
`
`
`11
`
`Page 16
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`that they were more flexible at their distal ends, and increased in rigidity moving
`
`proximally. Additionally, it was common to provide a transition of gradually
`
`decreasing rigidity between a relatively stiff portion of a catheter and a relatively
`
`flexible portion of the catheter, so as to resist formation of kinks between the
`
`sections of different rigidities.
`
`33. Just one example is taught by Berg (Ex. 1051) and is illustrated in
`
`Figure 19 of Berg, excerpted below.
`
`
`
`Ex. 1051, Fig. 19 (color and annotations added).
`
`34. Berg teaches a guide catheter design in which the distal tip is the most
`
`flexible portion and, moving distal to proximal, the catheter increases in rigidity.
`
`Specifically, and with reference to the regions identified in the figure above, Berg
`
`teaches a first flexural modulus portion 140 of between 1,000 and 15,000 psi; the
`
`
`
`12
`
`Page 17
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`second flexural modulus portion 142 is between 2,000 and 49,000 psi; the third
`
`flexural modulus portion 144 is between 13,000 and 49,000 psi; the fourth flexural
`
`modulus portion 146 is taught to be greater than 49,000 psi; and the fifth flexural
`
`modulus portion 148 is taught to be between 29,000 and 67,000 psi. Ex. 1051,
`
`13:66-14:67.
`
`35.
`
`In order to achieve the proper balance of rigidity and flexibility, it was
`
`common in the art to reinforce a catheter’s lumen. See Ex. 1015, 549; Ex. 1051,
`
`Fig. 19, 13:66-14:67. The reason for the varying rigidity, as mentioned above, is
`
`that while portions of the catheter must be flexible to navigate the curves of a
`
`patient’s anatomy, and portions must be soft enough that they are atraumatic to the
`
`vasculature (e.g., the distal tip), but proximal portions must be rigid enough such
`
`that a physician can transmit longitudinal and rotational forces to the catheter in
`
`order to locate the catheter to the target lesion. See Ex. 1051, 1:49-51.
`
`36. By the late 1990s, Berg discusses that it was common practice to add
`
`metal braiding or metal coils to the tubular structure of catheters “[t]o accomplish
`
`this balance between longitudinal rigidity, torsional rigidity, and flexibility.”
`
`Ex. 1051, 1:56-58. Berg states:
`
`This support member is often comprised of a metal braid or
`coil embedded in the shaft. This support wire is often
`embedded in the shaft between the two layers of tubing that
`comprise the shaft.
`
`
`
`13
`
`Page 18
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`
`Ex. 1051, 1:59-62 (note that “shaft” as used in Berg refers to the tubular
`
`structure of the lumen).
`
`37. Not surprising, many references disclose the practice of strategically
`
`locating metal reinforcements within the tubular structure of a catheter and discuss
`
`using a metal reinforcement to resist kinking. See Ex. 1007, 2:15-21; see also
`
`Ex. 1008, 6:66-7:6, 7:19-28, 23:53-58.
`
`38. Mihara also teaches the common practice of using metal
`
`reinforcement in the shape of braiding and coiling as well as reinforcing with a
`
`bar-shaped structure. See Ex. 1033, [0053] (“In this embodiment, the reinforcing
`
`body 34 is a spiral coil composed of tungsten. The reinforcing body 34 is placed
`
`in such a manner that the reinforcing body 34 is buried in the outer layer 33 (or
`
`the inner layer 32). The reinforcing body 34 is not limited to a spiral coil, and may
`
`be a braided body (net-shaped body), a bar-shaped body, or the like. Its material is
`
`not limited to tungsten. The reinforcing body 34 may be made of stainless steel or
`
`the like.”)
`
`39.
`
`It was known that using a coil for reinforcement (instead of a braid)
`
`was beneficial because coiling results in a catheter with less axial stiffness. A
`
`catheter (or portion thereof) with less axial stiffness is more flexible, and is easier
`
`to navigate or advance around curves in the vasculature.
`
`
`
`14
`
`Page 19
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`40. By contrast, using a coil for reinforcement could sometimes be a
`
`disadvantage. Depending on the direction that a catheter reinforced with coil is
`
`twisted, a difference in “torquability” may be observed. Twisting the catheter in
`
`one direction would tighten the spring like coil, while twisting it in the other
`
`would loosen the coil. This difference in “feel” depending on torque direction is
`
`considered undesirable.
`
`41.
`
` It was also known that using a braid for reinforcement (instead of a
`
`coil) was beneficial because braiding increases axial stiffness and reduces the
`
`likelihood of stretching or compressing the catheter lengthwise during
`
`manipulation by the physician. This means, for example, that if a physician pulls
`
`on the proximal end of the catheter so that it moves by 1/16th of an inch, the distal
`
`end of the catheter will also move by 1/16th of an inch.
`
`42. An additional benefit of using a braid for reinforcement relates to the
`
`relative outer and inner diameters of the catheter. Dinh teaches that a metal braid
`
`reinforcement in a catheter enables a small outer diameter as compared to a
`
`relatively large inner diameter at the same time as maintaining kink resistance,
`
`flexibility and torqueability. Ex. 1046, 2:17-26, 1:37-47.
`
`43. Truckai teaches that the same mechanical properties can be achieved
`
`in a thin-walled catheter with braiding as a thick catheter made solely of polymer.
`
`
`
`15
`
`Page 20
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`Ex. 1047, Abstract, 4:10-26. By embedding the braid elements within the polymer
`
`wall of the catheter, even thinner catheters can be achieved. Id.
`
`44. Adams also teaches that a coil reinforcement or a braided
`
`reinforcement can be used in its guide seal. See Ex. 1035, [0075].
`
`45. Reinforcing a catheter with metal braiding or metal coiling imparted
`
`enough strength in a catheter lumen to enable a physician to transmit longitudinal
`
`and torsional forces without the lumen kinking. Due to the open structural nature
`
`of a braid or coil, a catheter containing such reinforcement maintains enough
`
`flexibility for the lumen to bend around curves in a patient’s anatomy.
`
`46. Furthermore, in order to minimize the wall thickness of a catheter
`
`(and thus increase the inner diameter of the lumen), braiding is superior to coiling
`
`to achieve a balance of flexibility, kink resistance, torsional stiffness, and axial
`
`stiffness.
`
`VI. Overview of Ressemann and Common Teachings in the Art
`47. U.S. Pat. No. 7,604,612 to Ressemann (“Ressemann”) was filed
`
`August 9, 2002 and issued October 20, 2009.
`
`48. Ressemann teaches “a partial length evacuation sheath” used to
`
`“evacuat[e] emboli, particulate matter, and other debris from a blood vessel.”
`
`Ex. 1008, 3:59-61, 5:65-67. The evacuation sheath of Ressemann is intended to be
`
`
`
`16
`
`Page 21
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`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. 1008, 12:26-30.
`
`49. 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.
`
`50. 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,
`
`10:60-63, 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.
`
`51. 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
`
`the tube is “angled” to impart more flexibility at the distal tube’s end. See id.,
`
`7:48-51.
`
`
`
`17
`
`Page 22
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`
`Ex. 1008, Fig. 1C (color added).
`
`52. Ressemann also teaches deploying a stent through evacuation head
`
`132, as shown below in Figure 6E, excerpted below.
`
`
`
`
`
`Ex. 1008, Figure 6E (color and annotations added).
`
`
`
`18
`
`
`
`Page 23
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`VII. Overview of Kataishi
`53. Kataishi is a U.S. Patent Application published on January 20, 2005 as
`
`U.S. Pub. No. 2005/0015073.
`
`54. Kataishi discloses a suction catheter for removing a thrombus from a
`
`coronary artery. Ex. 1025, [0001]. It teaches a distal opening designed, in part, to
`
`improve the catheter’s “crossing ability,” which is its ability to smoothly reach a
`
`desired target site. Id., Abstract, [0001].
`
`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 is formed to be flat
`and flexible. With the distal end configuration, suction and
`crossing are significantly improved.
`Ex. 1025, Abstract.
`55. Figure 12 of Kataishi is a schematic of this distal opening with
`
`superior “crossing ability.” Ex. 1025, Fig. 12.
`
`
`
`19
`
`
`
`Page 24
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`Ex. 1025, Fig. 12.
`
`56.
`
`In addition to providing flexibility, the shape of the catheter’s distal
`
`opening improves its ability to suction thrombi (id., Abstract, [0026]-[0027],
`
`Fig. 10) which corresponds to loading a thrombus into the catheter’s distal end.
`
`The reason for this improved ability to load matter is the increased surface area
`
`formed by a two-incline opening.
`
`
`
`Ex. 1025, Fig. 10 (annotation added).
`
`57. The distal end has an “angled cut surface, in which at least a part on
`
`the proximal end side of the angled surface is formed in a concave shape in the
`
`angled direction and the distal end side of the cut surface is formed to be flat and
`
`flexible . . . .” Id., [0010]. The catheter tip is shown below. Id., Figs. 2, 12.
`
`
`
`20
`
`Page 25
`
`Medtronic Exhibit 1042
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1918
`Medtronic v. Teleflex
`
`

`

`IPR2020-00137
`Patent RE47,379
`
`
`
`Ex. 1025, Fig. 2 (annotation added).
`
`58. Cut surface 16 has a concave shape 161 that is closest to the fully
`
`circumferential portion of catheter lumen 11. The concave shape is adjacen