BSC USP 8,142,413
`Exhibit 1031
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`Page 1 of 180
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`CASE 0:13-cv-01172-JRT-SER Document 31 Filed 07/08/13 Page 1 of 4
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
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`___________________________________
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`VASCULAR SOLUTIONS, INC.,
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`Plaintiff,
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`v.
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`BOSTON SCIENTIFIC CORP.,
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`Defendant.
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`___________________________________ )
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`Civil File No. 0:13-cv-01172-JRT-SER
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`DECLARATION OF ANTHONY C. VRBA
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`I, Anthony Vrba, declare and state as follows:
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`1.
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`I have reviewed the Motion for Preliminary Injunction filed by Vascular
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`Solutions, Inc. (“VSI”) against Defendant Boston Scientific Corp. (“BSC”). BSC has asked me
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`to determine whether the elements of certain claims of U.S. Patent No. 8,048,032 B2 (the “ ‘032
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`patent”), U.S. Patent No. 8,142,413 B2 (the “ ‘413 patent”), and U.S. Patent No. 8,292,850 B2
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`(the “ ‘850 patent”) (collectively, the “VSI patents”) were (1) disclosed in U.S. Patent No.
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`5,527,292 (the “Adams ‘292 patent”), (2) known, as of 2004, to those of ordinary skill in art of
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`designing of catheters for use in interventional cardiology and the treatment of vascular disease,
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`and (3) disclosed in other patents relating to the design of catheters for use in interventional
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`cardiology and the treatment of vascular disease that issued prior to 2004. I have also been asked
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`to opine on the meaning of the term “lumen,” as it is generally used and understood in the art,
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`and how it would be construed with respect to the asserted claims of the VSI patents.
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`2.
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`I have reviewed the VSI patents and believe that the field to which they relate is the
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`design of catheters for use in interventional cardiology and the treatment of vascular disease. I
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`believe that I am a person of at least ordinary skill in that art based on the following: (1) my
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`education as a degreed mechanical engineer; (2) my experience in the relevant technology having
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`worked within the space of vascular medical devices for the past 22 years; (3) my extensive
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`experience in vascular medical device design and development, including the design and
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`development of catheters; (4) my research, development, and laboratory experiences with various
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`types of guide catheters and other vascular medical devices at various stages of pre-clinical prototype
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`evaluation and clinical observation; (5) my involvement in the invention and development of
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`commercial guide catheter products; (6) my review of the medical and patent literature; and (7) my
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`review of documents pertaining to this litigation.
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`I am currently the General Manager and Senior Vice President of Product Development for
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`Devicix, a medical device product development design firm. I am familiar with the history of guide
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`catheters and related technologies in the vascular medical device field. I have managed the design
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`and development of numerous vascular medical devices during the course of my career, including
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`interventional access devices such as guide sheaths, guide catheters, guidewires, and interventional
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`therapeutic devices such as balloon catheters and stents. I currently have 46 patents and 50
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`pending patent applications on a range of interventional devices including guidewires, balloons,
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`stents and stent delivery systems.
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`3.
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`BSC is compensating me for the time I am expending in connection with this case
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`at the rate of $ 250 per hour and reimbursing me for any expenses I incur in connection with the
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`case. I have no interest in the outcome of the case.
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`4.
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`In connection with the preparation of this declaration, I have reviewed the VSI
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`patents, the Adams ‘292 patent, and portions of certain other patents referenced in Exhibit 1 to
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`this declaration. I have also reviewed the declaration of VSI’s CEO Howard Root filed in
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`support of VSI’s motion for a preliminary injunction. During the course of my review and
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`2
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`analysis I have also relied on my own education and experience in the field of designing
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`catheters for use in interventional cardiology and the treatment of vascular disease.
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`5.
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`I believe that all of the elements of claims 1-8, 11-17, and 19 of the ‘032 patent,
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`claims 1, 2, 4, 5, and 7-13 of the ‘413 patent, and claims 1-8, 12-18, and 20 of the ‘850 patent
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`(the “asserted claims”) were (1) disclosed in the Adams ‘292 patent, (2) known, as of 2004, to
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`those of ordinary skill in art of designing catheters for use in interventional cardiology and the
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`treatment of vascular disease, and/or (3) disclosed in other patents relating to the design of
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`catheters for use in interventional cardiology and the treatment of vascular disease that issued
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`prior to 2004. Indeed, the Adams ‘292 patent, by itself, discloses all of the elements of many of
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`the asserted claims. Further, any elements of the asserted claims not expressly disclosed by the
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`Adams ‘292 patent comprise only minor, obvious variations on the Adams ‘292 technology.
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`That such variations would have been obvious in 2004 to one of skill in the art is apparent from
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`my own knowledge and experience in the field and underscored by the wealth of art reading on
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`such limitations that was published as of 2004. The bases for my conclusions—including
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`citations to specific portions of specific patents—are set forth in detail in the chart attached to
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`this declaration at Exhibit A.
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`6.
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`Within the field of catheter design, the term “lumen” generally refers to the space
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`or cavity within a tubular structure. Accordingly, I believe the “push rod” of Guidezilla has a
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`lumen. Guidezilla’s push rod is constructed from a stainless steel hypotube, which is essentially
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`a tube with a lumen through its center. I have used the term “lumen” and have heard it used in
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`the context of catheter design throughout my career. Based on my understanding of how those
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`of skill in the art use the term “lumen,” a hypotube has a lumen even if it is flattened or blocked
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`at one or both ends. Thus, Guidezilla’s push rod, which is part of the “substantially rigid
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`portion,” has a lumen.
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` I
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` declare under penalty of perjury that the foregoing is true and correct.
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`Executed on this __ day of July, 2013, in ___________ County, Minnesota.
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`____________________
`Anthony Vrba
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`4
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 1 of 70
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`EXHIBIT A
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 2 of 70
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`EXHIBIT A
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`INVALIDITY CHART
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`U.S. PATENT NO. 8,048,032 B2 (‘032 PATENT)
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`Claim
`Element No. Claim Element
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`Discussion of Prior Art
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`1.1.1
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`1. A device for use with a standard
`guide catheter,
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`U.S. Patent No. 5,527,292 (the “Adams ‘292 patent”) (attached hereto as
`Exhibit B) discloses a device for use with a standard guide catheter:
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`1.1.2
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`the standard guide catheter having a
`continuous lumen extending for a
`predefined length from a proximal
`end at a hemostatic valve to a distal
`end adapted to be placed in a
`branch artery,
`
`“For use in combination with a guide catheter …, an intravascular
`device …” (col. 23, ll. 33-35)
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`“An intravascular device … for insertion into a coronary vessel beyond
`a distal end of a guide catheter.” (abstract)
`
`The Adams ‘292 patent discloses a standard guide catheter having a continuous
`lumen extending for a predefined length from a proximal end at a hemostatic
`valve to a distal end adapted to be placed in a branch artery:
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`“The guide catheter 12 is an elongated, flexible, tubular member
`defining a first guide catheter lumen 27 therethrough.” (col. 5, ll. 30-32)
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`“a guide catheter having a proximal end, a distal end, and a central
`lumen,” (col. 23, ll. 33-34)
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`“The guide catheter manifold 16 is mounted at the proximal end of the
`guide catheter 12…. [T]he guide catheter manifold 16 comprises a Y-
`shaped structure having a primary channel leg 17…. A hemostasis
`valve (not shown) on channel leg 17 provides hemostatic control for the
`guide catheter system….” (col. 5, ll. 16-29; see col. 11, ll. 20-30)
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`“the guide catheter is … advanced through a patient’s arterial system to
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`1
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 3 of 70
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`EXHIBIT A
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`1.1.3
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`the continuous lumen of the guide
`catheter having a circular cross-
`sectional inner diameter sized such
`that interventional cardiology
`devices are insertable into and
`through the lumen to the branch
`artery,
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`1.2.1
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`the device comprising: a flexible tip
`portion defining a tubular structure
`having a circular cross-section and
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`the coronary ostium of the artery requiring treatment.” (col. 4, ll.56-58)
`
`Standard guide catheters having continuous lumens extending for a predefined
`length from a proximal end at a hemostatic valve to a distal end adapted to be
`placed in a branch artery were known to those of ordinary skill in the art by the
`mid-2000s.
`
`The Adams ‘292 patent discloses that the continuous lumen of the guide
`catheter having a circular cross-sectional inner diameter sized such that
`interventional cardiology devices are insertable into and through the lumen to
`the branch artery:
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`“Guide catheter 52 is an elongated, flexible tubular member defining a
`first guide catheter lumen 53 through which an angioplasty balloon
`catheter 60 or some other angioplasty device is disposed and guided to a
`stenosis or obstruction.” (col. 11, ll. 17-20)
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`“the guide catheter 287 is manipulated until a distal opening 288 of the
`guide catheter 287 is aligned with the coronary ostium so that the guide
`catheter 287 will direct an original coronary treatment device, such as an
`angioplasty balloon catheter, or a subsequent coronary treatment device
`into the coronary artery requiring treatment.” (col. 16, ll. 39-44)
`
`The Adams ‘292 patent discloses a device comprising: a flexible tip portion
`defining a tubular structure having a circular cross-section:
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`“An intravascular device having an elongated flexible tube” (abstract)
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`“The intravascular device includes a relatively flexible tube…. The
`flexible tube has an inner diameter” (col. 2, ll. 44-50)
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`“a relatively flexible tube having ... an internal lumen” (col. 23, ll. 36-
`37)
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`2
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 4 of 70
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`EXHIBIT A
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`“The guide catheter extension 14A … has a longitudinal guide catheter
`extension lumen, a rounded distal tip 36A and may be reinforced by a
`coil 40A.” (col. 7, ll. 4-7)
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`A person of ordinary skill in the art would have known of a tubular structure
`that includes a flexible cylindrical distal tip portion and a flexible cylindrical
`reinforced portion proximal to the flexible distal tip portion
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`Patents issued prior to 2004 disclosed a tubular structure that includes a flexible
`cylindrical distal tip portion and a flexible cylindrical reinforced portion
`proximal to the flexible distal tip portion. For example:
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`“An intravascular catheter such as a guiding catheter … having a
`nontraumatic distal tip comprising a proximal elastomeric tubular
`element and a distal elastomeric tubular element formed of a softer
`material….” U.S. Patent No. 5,234,416 (“Macaulay”) (attached hereto
`as Exhibit C) (abstract)
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`3
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`EXHIBIT A
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`Macaulay (Fig. 3).
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`“At the distal end of the segmented catheter 10 is an atraumatic tip 19
`that possesses softness or even elastic properties as will be generally
`appreciated by those skilled in the art.” U.S. Patent No. 5,658,263
`(“Dang”) (attached hereto as Exhibit D) (col. 6, ll. 9-12)
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`Dang (Fig. 2).
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`“[G]uiding catheter bodies are typically formed with…relatively short
`and soft distal tips….” U.S. Patent No. 6,592,472 B1 (“Noone”)
`(attached hereto as Exhibit E) (col. 2, ll. 22-24)
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`The Adams ‘292 patent discloses a tubular structure having a length that is
`shorter than the predefined length of the continuous lumen of the guide catheter:
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`See Fig. 1 (the second guide catheter lumen 33 of the elongated flexible
`tube 32 of the guide catheter extension 14 (red) is shorter than the guide
`catheter lumen 27 of the guide catheter 12 (green))
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`4
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`1.2.2
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`a length that is shorter than the
`predefined length of the continuous
`lumen of the guide catheter,
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`EXHIBIT A
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`See Figs. 12, 13 (flexible tube 255 is shorter than guide catheter 287)
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`5
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`EXHIBIT A
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`1.2.3
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`the tubular structure having a cross-
`sectional outer diameter sized to be
`insertable through the cross-
`sectional inner diameter of the
`continuous lumen of the guide
`catheter
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`The Adams ‘292 patent discloses that [t]he length of the flexible tube 32 is
`preferably approximately 6 to 10 inches” (col. 5, ll. 61-63). One of ordinary
`skill in the art would have known that a standard guide catheter is 100cm or
`approximately 40 inches long.
`
`The Adams ‘292 patent discloses a tubular structure having cross-sectional
`outer diameter sized to be insertable through the cross-sectional inner diameter
`of the continuous lumen of the guide catheter:
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`“The outer diameter of the elongated flexible tube 32 is smaller than the
`first guide catheter lumen 27 defined by the guide catheter 12 so that it
`may be slidably disposed therethrough …” (col. 5, ll. 64-67)
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`“a relatively flexible tube having … an outer diameter … wherein the
`outer diameter is sized for insertion through the central lumen of the
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`6
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`EXHIBIT A
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`1.2.4
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`defining a coaxial lumen having a
`cross-sectional inner diameter
`through which interventional
`cardiology devices are insertable;
`and
`
`guide catheter …” (col. 23, ll. 37-40)
`The Adams ‘292 patent discloses a tubular structure defining a coaxial lumen
`having a cross-sectional inner diameter through which interventional cardiology
`devices are insertable:
`
`“the flexible tube being concentrically aligned with the guide catheter”
`(col. 22, ll. 42-43)
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`“The inner diameter of the flexible tube is larger than the outer diameter
`of a typical angioplasty balloon catheter or other coronary treatment
`device.” (col. 2, ll. 62-64)
`
`“For use in combination with a guide catheter for insertion and
`advancement of a coronary treatment device ..., an anchoring device
`comprising … a relatively flexible tube …” (col. 22, ll. 35-40)
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`“The flexible tube 255 of the intravascular device 250 is designed for
`coaxial placement relative to the guide catheter …” (col. 15, ll. 65-66)
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`“During use, the guide catheter extension tube 70 is coaxially disposed
`within the guide catheter 52.” (col. 11, ll. 58-60)
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`1.3.1
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`a substantially rigid portion
`proximal of and operably connected
`to, and more rigid along a
`longitudinal axis than, the flexible
`tip portion and defining a rail
`structure without a lumen and
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`The Adams ‘292 patent discloses a substantially rigid portion proximal of and
`operably connected to, and more rigid along a longitudinal axis than, the
`flexible tip portion and defining a rail structure without a lumen:
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`“shaft 19 or push rod is attached to a proximal end of the elongated
`flexible tube 32” (col. 6, ll. 1-2)
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`“One embodiment is shown in FIG. 2 and the shaft 19 or push rod is
`defined by an elongated wire.” (col. 6, ll. 1-2)
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`7
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`EXHIBIT A
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`1.3.2
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`having a maximal cross-sectional
`dimension at a proximal portion
`that is smaller than the cross-
`sectional outer diameter of the
`flexible tip portion and
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`“The shaft 19A or push rod in this embodiment comprises a tubular
`shaft member 172.... The tubular shaft member 172 is preferably formed
`from a stainless steel hypotube….The tubular shaft member 172 has a
`flattened distal end which assumes an elongated cross-section…. The
`flattened distal end provides sufficient surface area to secure the tubular
`shaft member 172 to the proximal end of the elongated flexible tube
`32A….” (col. 7, ll. 13-26)
`
`“The push rod 262 is preferably formed of a nitinol wire.…. The nitinol
`construction helps reduce wire kinking as the push rod 262 is
`manipulated.” (col. 15, ll. 8-12)
`
`The Adams ‘292 patent discloses a substantially rigid portion having a maximal
`cross-sectional dimension at a proximal portion that is smaller than the cross-
`sectional outer diameter of the flexible tip portion:
`
`“The elongated wire 34 is of small diameter, preferably 0.010 to 0.016
`of an inch in diameter.” (col. 6, ll. 15-17)
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`“The tubular shaft member 172 is preferably formed from a stainless
`steel hypotube with an outside diameter of 0.016 inch.”
`(col. 7, ll. 18-21)
`
`The Adams ‘292 patent discloses that “the outer diameter of the elongated tube
`would be approximately 0.065 inch….” (col. 8, ll. 24-25) One of ordinary skill
`in the art would have known that the inner diameter of standard guide catheters
`(and, thus, the maximum outer diameter of the guide catheter extension) is 5F to
`8F or 0.058 inch to 0.088 inch.
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`1.3.3
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`having a length that, when
`combined with the length of the
`flexible distal tip portion, defines a
`total length of the device along the
`
`The Adams ‘292 patent discloses a substantially rigid portion having a length
`that, when combined with the length of the flexible distal tip portion, defines a
`total length of the device along the longitudinal axis that is longer than the
`continuous lumen of the guide catheter:
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`8
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 10 of 70
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`EXHIBIT A
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`longitudinal axis that is longer than
`the continuous lumen of the guide
`catheter,
`
`1.4
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`such that when at least a distal
`portion of the flexible tip portion is
`extended distally of the distal end
`of the guide catheter, at least a
`portion of the proximal portion of
`the substantially rigid portion
`extends proximally through the
`hemostatic valve in common with
`interventional cardiology devices
`that are insertable into the guide
`catheter.
`
`“The flexible tube 255 is approximately 6.0 to 12.0 inches in length, and
`preferably 9.5 to 10.0 inches in length. The push rod is approximately
`40.0 to 45.0 inches in length. The overall length of the extension 250 is
`preferably 50.5 to 51.5 inches.” (col. 15, ll. 49-53)
`
`One of ordinary skill in the art would have known that a standard guide catheter
`is 100 cm or approximately 40 inches long.
`
`The Adams ‘292 patent discloses that when a distal portion of the flexible tip
`portion is extended distally of the distal end of the guide catheter, a portion of
`the proximal portion of the substantially rigid portion extends proximally
`through the hemostatic valve in common with interventional cardiology devices
`that are insertable into the guide catheter:
`
`“The elongated flexible tube 32 of the guide catheter extension 14 is
`designed to extend beyond a distal end of the guide catheter 12….” (col.
`6, ll. 8-10)
`
`“As seen in FIG. 1, shaft 19 or push rod … extends proximally …
`outside the guide catheter 12 so that it is accessible to the user.”
`(col. 6, ll. 1-4)
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`9
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 11 of 70
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`EXHIBIT A
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`2.1
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`2. The device of claim 1 wherein
`the tubular structure includes a
`distal portion adapted to be
`extended beyond the distal end of
`the guide catheter while a proximal
`portion remains within the lumen of
`the guide catheter,
`
`17 is the primary channel leg of the catheter manifold, where the
`hemostatic valve (not shown) is located. (col. 5, ll. 17-29.) 26 is a
`balloon catheter shaft. (col. 8, l. 40) 19 is the shaft or push rod, which
`exits the manifold at the same point as the balloon catheter shaft.
`
`“The total length of the extension 250 permits the flexible tube 255 to
`remain with the guide catheter 287 and to extend beyond a distal end of
`guide catheter 287 into and through a coronary artery while the control
`knob 264 remains outside the patient.” (col. 17, ll. 3-7)
`
`The Adams ‘292 patent discloses a tubular structure that includes a distal
`portion adapted to be extended beyond the distal end of the guide catheter while
`a proximal portion remains within the lumen of the guide catheter:
`
`“A distal portion of the flexible tube 255 is advanced past the distal
`opening 288 of the guide catheter 287 … while a proximal portion
`thereof and the push rod 262 remain within the guide catheter 287.”
`(col. 16, ll. 60-64)
`
`“A proximal end of the flexible tube 32 is advanced so that a significant
`portion of the flexible tube 32 extends … beyond the distal end of the
`guide catheter 12….” (col. 9, ll. 17-22)
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`10
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`EXHIBIT A
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`2.2
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`such that the device assists in
`resisting axial and shear forces
`exerted by the interventional
`cardiology device passed through
`and beyond the coaxial lumen that
`would otherwise tend to dislodge
`the guide catheter from the branch
`artery.
`
`“The length of the tube is sized so that the proximal end … of the tube
`255 is enclosed within the guide catheter while the distal end of the
`flexible tube 255 reaches the treatment site.” (col. 15, ll. 57-60)
`
`“In use, the flexible tube has its proximal end within a guide catheter
`and has its distal end extending to a treatment site within a coronary
`artery.” (abstract)
`
`The Adams ‘292 patent discloses that the device assists in resisting axial and
`shear forces exerted by the interventional cardiology device passed through and
`beyond the coaxial lumen that would otherwise tend to dislodge the guide
`catheter from the branch artery:
`
`“The extension of the elongated flexible tube 32 into the smaller
`dimension arteries also serves to maintain the position of the guide
`catheter 12 at the coronary ostium during operation…. [T]he flexible
`tube 32 defines an anchoring device for securing the guide catheter 12
`for operation.” (col. 9, ll. 12-17)
`
`“[A]s a coronary device is advanced, the position of the distal opening
`288 of the guide catheter 287 may shift out of alignment with the
`coronary ostium making placement of the coronary treatment device
`into the coronary artery requiring treatment more difficult.
`As previously explained, the present invention discloses an anchoring
`device for securing the guide catheter 287 relative to the coronary
`ostium of a patient to facilitate original insertion and subsequent
`insertion of a coronary treatment device.” (col. 16, ll. 49-58)
`
`3
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`3. The device of claim 2 wherein
`the proximal portion of the tubular
`structure further comprises structure
`defining a proximal side opening
`extending for a distance along the
`
`A person of ordinary skill in the art would have known and been motivated to
`shape the proximal side opening of the tubular structure disclosed in the Adams
`‘292 patent to extend for a distance along the longitudinal axis such that it
`would thereby be accessible from a longitudinal side defined transverse to the
`longitudinal axis to receive an interventional cardiology device into the coaxial
`
`11
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 13 of 70
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`EXHIBIT A
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`longitudinal axis, and accessible
`from a longitudinal side defined
`transverse to the longitudinal axis,
`to receive an interventional
`cardiology device into the coaxial
`lumen while the proximal portion
`remains within the lumen of the
`guide catheter.
`
`lumen with the proximal portion of the tube remaining within the lumen of the
`guide catheter:
`
`The type of proximal side opening described in claim 3 was well known
`in the art prior to 2004 as a common means of shaping points of entry
`into a lumen through which devices are received for the facilitation of
`insertion and strengthening known points of weakness through gradual
`transitioning at portions joining one material to another or one degree of
`flexibility to another. Accordingly, utilizing such a design at the
`proximal end of the flexible tube disclosed by Adams ‘292 would have
`been obvious to a person of ordinary skill in the art as a means of
`creating a smooth transition for devices to travel from the substantially
`rigid portion into the coaxial lumen of the flexible tube.
`
`By 2004, sloped or angled openings to lumens were well known to
`persons of ordinary skill in the art of rapid exchange catheters, as well as
`the art of interventional catheters generally.
`
`Examples of patents prior to 2004 disclosing this feature within the
`relevant field of technology include:
`
`U.S. Patent No. 5,690,613 (“Verbeek”) (attached hereto as Exhibit F)
`discloses cutting an angled proximal side opening commonly known as a
`“skive” in the inner lumen tube of a rapid exchange catheter for the
`receipt of a guidewire. See, e.g., Fig. 1B (depicting “longitudinal cross-
`section of the transition section”):
`
`12
`
`

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`Page 18 of 180
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 14 of 70
`
`EXHIBIT A
`
`“Skive 95 the proximal end of the inner lumen tubing 70 at an angle of
`approximately 10 degrees for a length of 2 mm.” Verbeek (col. 6, ll. 9-
`11).
`
`All prior art catheters with such side openings have “full circumference
`portions” and “partially cylindrical portions,” as depicted in U.S. Patent
`No. 5,328,472 (“Steinke”) (issued in July 1994), for a “Catheter with
`Flexible Side Port Entry,” (attached hereto as Exhibit G), where “12” is
`defined as the “side port entry”:
`
`13
`
`

`

`Page 19 of 180
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 15 of 70
`
`EXHIBIT A
`
`Steinke discloses a catheter shaft defining a lumen with a proximal side
`port whereby “said lumen [is] adapted to receive a guidewire in a sliding
`fit.” Steinke (col. 4, ll. 1-2)
`
`“Generally, the method ... includes the steps of providing a side port
`entry in the transition region” Steinke (col. 3, ll. 33-34)
`
`“Preferably the side port entry is located about 20 centimeters from the
`distal tip 14 of the catheter. A guidewire 16 can be slidingly received
`within the inner lumen.” Steinke (col. 6, ll. 7-10)
`
`U.S. Patent No. 5,102,403 (“Alt”) (attached hereto as Exhibit H)
`discloses “a substantially cylindrical catheter body with an outer wall …
`with the outer wall gradually changing in shape along the catheter body
`length toward the distal end from an entrance groove …” Alt (col. 6, ll.
`62-66)
`
`Alt (Fig. 1):
`
`“Novel features of this catheter include the transition of the catheter
`tubing … to accommodate a second guide wire lumen …” Alt (col. 2, l.
`65-col. 3, l. 2)
`
`“Thus guide wire 21 enters the catheter body axially …” Alt (col. 6, l. 4)
`
`14
`
`

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`Page 20 of 180
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 16 of 70
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`EXHIBIT A
`
`Persons of skill in the art would have been motivated to combine their
`knowledge and the disclosures cited above with the disclosures of the Adams
`‘292 patent because they all address the delivery of devices for interventional
`cardiology and treatment of vascular disease.
`
`4
`
`4. The device of claim 3 wherein
`the proximal side opening includes
`structure defining a full
`circumference portion and structure
`defining a partially cylindrical
`portion.
`
`A person of ordinary skill in the art would have known of a proximal side
`opening that includes a structure defining a full circumference portion and a
`partially cylindrical portion:
`
`Patents issued prior to 2004 disclosed proximal side openings with structures
`defining full circumference portions and partially cylindrical portions:
`
`“guide catheter 21 enters the catheter body axially … through a groove,
`a crescent shaped semi-enveloping configuration, FIGS. 5 and 6, and
`then completely surrounded as in FIGS. 7 through 10.” Alt (col. 6, ll. 4-
`8)
`
`“a crescent shaped catheter body configuration partly surrounding the
`wire and … a closed cylinder wall surrounding a second guide lumen for
`encompassing the guide wire.” Alt (col. 6, l. 67-col. 7, l. 4)
`
`Alt (Figs. 5, 10):
`
`Persons of skill in the art would have been motivated to combine their
`knowledge and the disclosures cited above with the disclosures of the Adams
`
`15
`
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`Page 21 of 180
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 17 of 70
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`EXHIBIT A
`
`5
`
`6
`
`5. The device of claim 2 wherein
`the flexible cylindrical distal tip
`portion further comprises a
`radiopaque marker proximate a
`distal tip.
`
`6. The device of claim 1 wherein
`the tubular structure includes a
`flexible cylindrical distal tip portion
`and a flexible cylindrical reinforced
`portion proximal to the flexible
`distal tip portion.
`
`patent because the all address delivery of devices for interventional cardiology
`and treatment of vascular disease
`
`The Adams ‘292 patent discloses that the flexible cylindrical distal tip portion
`further comprises a radiopaque marker proximate a distal tip:
`
`“a radiopaque marker 43 may be placed just proximal to the rounded
`distal tip 36 of the guide catheter extension tube 32….” (col. 6, ll. 48-
`50)
`
`“an annular radiopaque marker 265 … is provided at the distal end of the
`flexible tube 255….” (col. 14, ll. 8-10)
`
`The Adams ‘292 patent discloses that the tubular structure includes a flexible
`cylindrical distal tip portion and a flexible cylindrical reinforced portion
`proximal to the flexible distal tip portion:
`
`“the relatively flexible tube of the intravascular device includes a coil
`spring extending along and defining at least a portion of the flexible
`tube.” (col. 20, ll. 3-6)
`
`“The guide catheter extension 14A … has a longitudinal guide catheter
`extension lumen, a rounded distal tip 36A and may be reinforced by a
`coil 40A.” (col. 7, ll. 4-7)
`
`16
`
`

`

`Page 22 of 180
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 18 of 70
`
`EXHIBIT A
`
`A person of ordinary skill in the art would have known of a tubular structure
`that includes a flexible cylindrical distal tip portion and a flexible cylindrical
`reinforced portion proximal to the flexible distal tip portion
`
`Patents issued prior to 2004 disclosed a tubular structure that includes a flexible
`cylindrical distal tip portion and a flexible cylindrical reinforced portion
`proximal to the flexible distal tip portion:
`
`“An intravascular catheter such as a guiding catheter … having a
`nontraumatic distal tip comprising a proximal elastomeric tubular
`element and a distal elastomeric tubular element formed of a softer
`material…. The catheter shaft includes an inner tubular member of
`braided polymeric fibrous strands … having an outer jacket or coating of
`thermoplastic polyurethane secured to the braided tubular member.”
`Macaulay (abstract)
`
`Macaulay (Fig. 3):
`
`“The guiding catheter of this invention is generally comprised of … at
`least three catheter segments which are progressively more flexible in
`the distal direction, and an atra[u]matic tip at the distal end.” Dang (col.
`3, ll. 10-13)
`
`“The segments of polymer preferably are molded about a braid of
`stainless steel or the like. Such braid is commonly used by those skilled
`in the art to enhance rigidity.” Dang (col. 3, ll. 61-64)
`
`17
`
`

`

`Page 23 of 180
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`CASE 0:13-cv-01172-JRT-SER Document 31-1 Filed 07/08/13 Page 19 of 70
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`EXHIBIT A
`
`“At the distal end of the segmented catheter 10 is an atraumatic tip 19
`that possesses softness or even elastic properties as will be generally
`appreciated by those skilled in the art.” Dang (col. 6, ll. 9-12)
`
`Dang (Fig. 2):
`
`7
`
`7. The device of claim 6 wherein
`the flexible cylindrical reinforced
`portion is reinforced with metallic
`elements in a braided or coiled
`pattern.
`
`“[G]uiding catheter bodies are typically formed with relatively long and
`stiff proximal sections or shafts and relatively short and soft distal
`tips….” Noone (col. 2, ll. 22-24)
`
`“Typically, the proximal section or shaft is formed of an inner tube,
`metal or polymeric filaments braided overlying the inner tube, and an
`outer tube over the braid, thereby providing a reinforced catheter shaft as
`disclosed in the above-referenced ‘910, ‘416, and ‘149 patents.” Noone
`(col. 2, ll. 22-24)
`
`The Adams ‘292 patent discloses that the flexible cylindrical reinforced portion
`is reinforced with metallic elements in a braided or coiled pattern:
`
`“Preferably, the elongated flexible tube 32 is formed of a coiled spring
`40 made of stainless steel or platinum alloy…. An outer coating of
`plastic is