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`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 1
`
`*-=-{*-""-.--
`\
`
`

`

`[Bl?ffie&s,$
`llB/:r{.$ft[s{}
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`PATENT APPLICATION
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`087021?0
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`APPROVED FOR LTCENSE [;l'
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`Entered
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`Counted
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`1.
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`6.
`
`T,
`
`11.
`
`12.
`
`13,
`
`14.
`
`15.
`
`16.
`
`17.
`
`19.
`
`2A.
`
`Tr.
`
`25.
`
`26.
`
`27.
`
`28.
`
`29.
`
`30.
`
`31.
`
`32.
`
`CONTENTS
`
`'
`
`r!:1.',,. .r Date
`: ., Received
`"":... Of
`.rr Mailed
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 2
`
`

`

`:t1:ry:ygqpa
`.i
`
`It
`
`'
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`/
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`q
`
`PATENT APP1ICATION SERIAI, NO.
`
`ft) /t^ / r'):arTd\
`,JA/ i'uri"L,lCI.j
`
`U.S. DEPAR1ilENT OF COM}(ERCE
`PATEM AT{D TNADEMARK OFFICE
`FEE RECORD SI{EET
`
`PTO-I556
`(s /87)
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 3
`
`

`

`BAR CODE LABEL
`
`ililIil ililil ilil ilililtilililil ililililil ilil ilil
`
`U.S. PATENT APPLICATION
`
`SERIAI NUMBEN
`
`o8/702,L'O
`
`FILING DATE
`
`CLASS
`
`GROUP ART UNIT
`
`08/23 /e6
`
`604
`
`3301
`
`LOUIS G. ELLIS,
`CHRISTOPHER R.
`
`ST ANTHONY, MNi ANDREW J. DUSBABEK, DAYTON' MNi
`LAWSON, ST PAUL, MN; TERRY V. BROWN, FRIDLEY' MN.
`
`F=o=Gq
`
`* * CONTINUf NG DATA* tr rr ?t tr * tr * * * * * tr rt tr t( * rr * * it
`VERIFIED
`
`**FOREIGN/PCT
`VERIFIED
`
`APPLICATIONS* * * * r, tr t r. t( * * rt
`
`FOREIGN FILING LTCENSE GRANTED t2/t8/95
`
`STATf OR
`:OUNTRY
`
`SHEETS
`DRAWING'
`
`TOTAL
`CTAIMS
`
`NDEPENOENT
`ItAtMS
`
`FILING IEE
`RECEIVED
`
`ITTORNEY DOCKET NO,
`
`3
`
`$1,208.00
`
`s63.2-6050
`
`MN
`
`4
`
`34
`
`OLIVER F ARRETT
`VIDAS ARRETT & STEINKRAUS
`920 SECOND AVENUE SOUTH
`SUITE 1540
`MINNEAPOLTS MN 55402.4OL4
`
`STENT DELIVERY SYSTEM
`
`oouGctc!
`
`uF
`
`This is to certify that annexed hereto is a true copv from the records of the United States
`Patent and Trademark Office of the application which is identified above.
`By authority of the
`COMMISSIONER OF PATENTS AND TRADEMARKS
`
`Cenifying 0fficer
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 4
`
`

`

`IN THE UNITED STATES PATENT AND T DEMARK OFFICE
`/nz.tba
`Louis G. Ellis, Andrew J. Dusbabek Christopher R.
`Larson, Terry V. Brown
`
`0B/v$m'[sO
`PATENT
`
`In Re Application of:
`K" RooD
`
`TITLE:
`
`IK:
`
`DELTVERY SYSTEM
`
`s63.2-60s0
`
`Docket
`
`\t?.
`-$
`Certificate
`1.10: I hereby certify that this Transmittal Ictter and the
`paper(s) as described herein, are being deposited in the U.S. Postal Service, as Express
`Mail Label No. EM1311430907US addressed to 'fBox Patent Application, Assistant
`commissioner for Patents, washington D.c. 20231, on .Luguii 23, Lgg6,
`
`Box Patent Application
`Assistant Commissioner for patents
`Washington, D.C. 2023I
`
`We are transmitting herewith the attached:
`lL
`:*
`
`PATENT APPLICATION: (Specification: 6 sheets; Claims: 3 sheet; Abstract: 1
`sheet; drawings: { sheet fiformal o informal)
`Assignment of inv'ention is enclosed for recordation (with Recordation Form Cover
`Sheet)_
`Declaration
`Power of Attorney, if from assignee, it is hereby certified that the undersigned has
`authority to make this certification and has reviewed all the documents in the chain
`of title of the patent application identified herein and, to the best of undersigned's
`knowledge and belief, title is in the assignee identified above (37 CFR 3.73ib).
`If filed under $1.600) a copy of the power of attorney from the prior application
`is enclosed.
`Verified Statement Claiming Small Entity
`Preliminary Amendment - Fee calculation based on amendment
`Information Disclosure Statement
`liling Fees: n $ for filing fee; n $ Assignment Recording Fee
`Other: Cover Sheet
`Return Post Card
`
`z\
`
`z\
`
`PRIORITY IS CLAIMED UNDER 35 U.S.C. $119. A certified copy priority
`application(s) is _ attached, _ will follow.
`FILING UNDER 37 CFR 1.60(b), PRIORITY IS CLAIMED UNDER 35 U.S.C.
`$120. The new application being transmitted claims the benefit of prior U.S.
`application(s). I hereby verify that the attached papers are a true copy of what is
`shown in my^records to be the prior application iaentifieA'in the preiiminary
`amendment, including the declaration, and that no amendments (if any) refened to
`in the declaration filed to complete the prior application introduced nir" -utter.
`(If papers are deemed not to be entitled to a filing date under 37 CFR g1.60, but
`would be eligible for a filing date under 37.CrR $ 1.53, these,papers should be
`%-'"
`\./ 1
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 5
`
`

`

`' ' treated as filec lder $1.53.)
`Charge Deposit Account No. 22-0350 the sum of $
`(new application filing fee ($-)
`and Recording Assignment fee ($40.00)
`
`FEE CALCULATION
`
`No. of Claims
`Filed
`
`Claims included
`in Base Fee
`
`No. of
`Extra
`Claims
`
`t4
`
`Rate
`
`Fees:
`
`x22
`x78
`
`s308.00
`
`$
`
`-20 :
`-3=
`
`34
`
`34
`
`Total Claims
`
`Independent
`Claims
`
`Multiple Dependent
`Claims
`
`-0-
`
`-0-
`
`-0-
`
`x 250
`
`$-0-
`
`E
`
`tr
`
`tr
`
`Basic Filing Fee ($750.00),
`
`Design Filing Fee ($310.00)
`TOTAL FEES BEFORE DEDUCTION (if any):
`Verified Statement Claiming Small Entity (deduct tl2 fee). If filed
`under $1.60 the verified statement has been filed in the parent
`application, and that status is still proper and desired.
`
`$ 750.00
`
`$10s8.00
`
`-$
`
`TOTAL:
`
`$10s8.00
`
`XX The Filing Fee will be paid with the response to the Notice of Missing Parts.
`
`In case of an error in the above fee calculations, please charge any additional fees
`or credits to Deposit Account 22-0350.
`
`Oliver F. Arrett
`
`@A
`
`ttorneys for Applicant
`
`2
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 6
`
`VIDAS, AnnErr A STEINRAUS
`f5-zt0 Kinnard Financial Center
`
`@@F
`
`acsimile No: (612) 349-6858
`Date: August 23, 1996
`
`

`

`ilL/V&Hfls0
`
`f"-w:l
`'Y 6ga ..t,
`q.;,..Y
`
`DOCKET NO. S63.2-60s0
`
`IN TIIE I.JNITED STATES PATENT AI\D TRADEMARK OFFICE
`APPLICATION FOR I.INITED STATES LETTERS PATENT
`
`TNVENTOR(S):
`
`Louis G. Ellis, Andrew J. Dusbabek, Christopher R. Larson,
`Terry V. Brown
`
`TITLE:
`
`STENT DELTVERY SYSTnI\4
`
`ATTORNEYS:
`
`F: \WPWORK\OFA\6060-COV. 820
`
`Oliver F. Anett
`VIDAS, ARRE'TT & STEINKRAUS
`1540 Kinnard Financial Center
`920 Second Avenue South
`Minneapolis, Minnes ota 55402-401.4
`Phone (612) 339-8801
`Fax (612) 349-6858
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 7
`
`

`

`ry
`
`f{;,\
`Q,:::P
`
`filwu{d?mo
`
`In typical PTCA procedures, a guiding catheter is percutaneously
`introduced into the cardiovascular system of a patient through a vessel and advanced
`through therein until the distal end thereof is at a desired location in the vasculature.
`A guidewire and a dilatation catheter having a balloon on the distal end thereof are
`introduced through the guiding catheter with the guidewire sliding through the
`dilatation catheter. The guidewire is first advanced out of the guiding catheter into
`the patient's coronary vasculature and the dilatation catheter is advanced over the
`previously advanced guidewire until the dilatation balloon is properly positioned
`across the lesion. Once in position across the lesion, the flexible, expandable,
`preformed balloon is inflated to a predetermined size with a liquid or gas at
`relatively high pressures, such as greater than about four atmospheres, to radially
`compress the arthrosclerotic plaque of the lesion against the inside of the artery wall
`and thereby ditate the lumen of the artery. The balloon is then deflated to a small
`profile so that the dilatation catheter may be withdrawn from the patients vasculature
`
`and blood flow resumed through ttre dilated artery,
`In angioplasty procedures of the kind described above, there may be
`restenosis of the ertery, which either necessitates another angioplasty procedure, a
`surgical by-pass operation, or some method of repairing or strengthening the area.
`To prevent restenosis and strengthen the area, a physician can implant an
`
`intravascular prosthesis for maintaining vascular patency, called a stent, inside the
`artery at the lesion. The stent is expanded to a larger diameter for placement in the
`vasculature, often by the balloon portion of the catheter. Stents delivered to a
`restricted coronary artery, expanded to a larger diameter as by a balloon catheter,
`and left in place in the artery at the site of a dilated lesion are shown in U.S. patent
`4,740,207 to Kreamer; U.S. Patent 5,007,926 to Derbyshire; U.S. Patent 4,733,665
`to Palmaz; U.S. Patent 5,026,377 to Burton et al.; U.S. Patent 5,158,548 to Lau et
`al.; U.S. Patent 5,242,399 to Lau et al.; U.S. 5,344,426 to Lau et al.; U.S. Patent
`5,4I5,664 to Pinchuk; U.S. Patent 5,453,090 to Martinez et al.; U.S. Patent
`4,950,227 to Savin; U.S. Patent 5,403,34t to Solar; U.S. Patent 5,108,416 to Ryan
`et al, and European Patent Application No. 707 837 A1 to Sheiban, all sf which are
`
`10
`
`15
`
`20
`
`30
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 8
`
`

`

`-2-
`
`incorporated herein by reference. A stent particularly preferred for use with this
`invention is described in PCT Application No. 960 3092 AL, published 8 February
`1996, the content of which is also incorporated herein by reference.
`The present invention is particularly directed to improved
`arrangements for releasably attaching the stent to the catheter to facilitate delivery
`
`thereof.
`
`10
`
`15
`
`2A
`
`25
`
`30
`
`Summary of the Invention
`This invention concerns apparatus suitable for delivery of stents to
`body cavities. In general, stents are prosthetic devices which can be positioned
`within a body cavity, for example, a blood vessel of the body of a living human or
`in some other difficultly accessible place. The stent prosthesis is formed of a
`generally fibular body, the diameter of which can be decreased or increased. Stents
`are particularly useful for permanently widening a vessel which is either in a
`narrowed state, or internally supporting a vessel damaged by an aneurysm. Such
`stents are typically introduced into the body cavlty by use of a catheter. The
`catheter is usually of the balloon catheter type in which the balloon is utilized to
`expand the stent, which is positioned over the balloon, to place it in a selected
`location in the body cavity, The present invention is particularly directed to
`improved arrangements for releasably attaching the stent to the catheter to facilitate
`delivery thereof. The stent is held in place on the catheter by means of an enlarged
`body canied by the catheter shaft within the balloon to which the stent and balloon
`are fitted, as by crimping.
`
`Brief Description of the Figures
`Figure 1 is an isometric view, a portion of which is enlarged and in
`longitudinal seetion, of a balloon catheter having a stent fixed to the catheter by
`
`being crimped thereto over the balloon;
`Figure 2 is an even more enlarged view in longitudinal cross-section
`of the distal end portion of the catheter of Figure 1;
`Figure 3 is an enlarged cross-sectional view of the distal end portion
`of the catheter of Figure 1 similar to that of enlarged view Figure 2 but showing the
`balloon in an expanded condition along with the expanded stent;
`
`fl
`
`\
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 9
`
`

`

`-3-
`
`Figure 4 is a schematic showing of a preferred mounting body carried
`by the catheter shaft within the balloon, the body being spirally cut to improve
`flexibiliry;
`
`Figure 5 is a schematic showing in cross-section of another
`embodiment of the invention with a stent not yet mounted;
`Figure 6 is a schematic showing of another embodiment of the
`
`invention;
`
`Figure 7 is a schematic showing of a means for conveniently crimping
`the stent on the embodiment shown in Figure 5, and
`Figure 8 is a schematic showing of yet another embodiment of the
`
`10
`
`invention.
`
`Description of the Preferred Embodiments
`Referring to Figures 1-3 a stent delivery system generally indicated at
`1S 10 includes a balloon catheter 12 having a balloon 14 on a distal end portion
`generally indicated at 16. Figure L shows a proximal portion of the catheter at 1'2a
`and a distal portion 12b in enlarged view. Figure 2 shows the distal end portion 16
`in an even more enlarged view. The illustrative catheter 12 is of the type known as
`a rapid exchange or single operator catheter. However, other types of catheters may
`20 be used, such as over the wire and fixed wire types. The balloon 14 is fixed to the
`catheter t2 by standard means. The balloon is shown in its contracted state in
`Figures t and 2. A stent 18 is fixed about the balloon by crimping it thereto. The
`stent has a larger expanded diameter which is obtained when the balloon is expanded
`in the known manner. That is, the stent is released from the catheter upon
`25 expansion of the balloon as shown in Figure 3 to be placed in a vessel. When the
`balloon is then deflated, removal of the balloon and catheter may be accomplished
`while leaving the stent in place.
`As js known in the art the balloon is either bondgd at its ends by
`to thE outer memAe, Zh&#ecatheter and to the
`Cp
`adhesive ,O
`^n?brespectively
`30 inner member 26 of the catheter in the manner as shown, or is made one-piece with
`the outer member as is known in the art. The catheter balloon may be inflated by
`fluid (gas or liquid) from an inflation port extending from a lumen 28 contained in
`the catheter shaft and opening into the balloon as shown, or by other known
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 10
`
`

`

`-4-
`
`anangements, depending on the design of the catheter. The details and mechanics
`of balloon inflation and specific overall catheter construction will vary according to
`the particular design involved in any given instance, and are known in the art per se.
`All variations are acceptable for use with this invention.
`Any balloon expandable stent may be used with this invention. Many
`are known in the art including plastic and metal stents. Some are more well known
`
`such as the stainless steel stent shown in U.S. Patent 4,735,665; the wire stent
`shown in U.S. Patent 4,950,227; another metal stent shown in European Patent
`Application EPO 707 837 A1 and that shown in U.S. Patent 5,445,646. All of these
`patents are incorporated herein by reference. Also, shape memory metal stents may
`be used. As already indicated the stent of PCT Application 960 3092 A1 is
`particularly preferred.
`
`The stent is typically about 16mm long, while the balloon may be
`20mm long. These dimensions, however, are merely representative for illustrative
`purposes only and are not meant to be limiting. The stent is positioned over the
`balloon portion of the dilatation catheter and gently crimped onto the balloon either
`by hand or with a tool such as a pliers or the like to be mounted for delivery as
`shown in Figures I and 2. The crimping may be accomplished by either the
`manufacturer or the physician.
`In accordance with this invention, a mounting body 30, best seen in
`Figures 2 and 3, is included inside balloon 14 to provide a cushion and/or substrate
`of enlarged diameter relative to the stent shaft to support and hold the stent and
`secure it during crimping and the delivery procedure. The mounting body may be
`located only in the body ortion of the balloon or may extend into either or both of
`the cone portions of the balloon.
`In the embodiment shown, mounting body 30 is cylindrical in form
`and takes the shape of a sleeve carried on inner lumen 26, providing an enlarged
`area or portion for receiving the balloon and stent when the latter is crimped.
`Marker bands 32 and,34 may also be included on inner 26 as shown. Any
`radiopaque material such as gold is useful for this purpose. A stop member 36 of
`generally conical shape or any other shape may also be included on the distal marker
`band 34 as shown to provide additional resistance to stent movement during delivery
`and to protect the leading edge of the stent during delivery. A proximal stop
`
`10
`
`i5
`
`20
`
`25
`
`30
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 11
`
`

`

`-5-
`
`member similar to member 36 (not shown) may be optionally included on marker
`band 32 if desired. Polyethylene or the like is suitable for the stop member(s).
`Although, the material of the mounting body may be hard, it is preferably of any
`deformable thermoplastic material, preferably an elastomer material and more
`preferably of a relatively resilient elastomer material, e.g., lower durometer silicone.
`A preferred deformable thermoplastic material is high density polyethylene (HDpE).
`A preferred lower durometer silicone is in the form of tubing. The deformation of
`resilient material of the mounting body when the stent/balloon is crimped to it causes
`a radial outward force on the stent/balloon increasing the friction therebetween
`despite a recoil of the stent.
`
`During delivery, the balloon catheter is advanced through and
`positioned in a patient's vasculature so that the stent is adjacent to the portion of the
`vessel where treatment is to take place. The balloon is inflated to expand the stent
`to an enlarged diameter. When the stent has reached the desired diameter, the
`balloon is deflated so that the catheter may be rernoved leaving the stent in place.
`Another embodiment of the invention is shown in Figure 4. In this
`embodiment the mounting body 30 is a spiral cut elastomer or other suitable
`material, such as a rigid or flexible plastic, to provide separation for flexibility in
`that portion of the catheter, allowing more easy movement or tracking around bends.
`The spiral cut may be only partly through the mounting body or may be all the way
`through as shown in Figure 4. Also, while stop members 36 are shown at both ends
`of mounting body 30 in this embodiment, one, or no stop members may be used.
`Another similar version is shown in Figure 5 which includes a
`cylindrical mounting body 30 made up of a plurality of separate adjacent rings 30a.
`Rings 30a may be individual bodies carried on the sheath sr bodies cut from a
`cylinder partially separating them or fully separating them.
`The embodiment shown in Figure 6 includes another feature based on
`the geometry of the mounting body for fuither securing the stent upon crimping.
`This feature is referred to herein as interlocking. That is, the stent may be
`interlocked to the mount so that the stent cannot slide proximally or distally on the
`balloon unless it is deformed, such as by expansion. This can be seen by perusing
`the structure shown in Figure 6 which includes the inner 26 having a two-piece
`mounting body made up of spaced mounting bodies 30a and 30b. The spacing
`
`10
`
`is
`
`20
`
`25
`
`30
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 12
`
`{{\
`
`/"r\*"-J
`
`

`

`-6-
`
`between bodies 30a and 30b allows portions of the stent 18 and balloon 14 to be
`depressed or inserted between the bodies upon crimping of the stent thus forming an
`interlock against sliding longitudinally before the stent is released.
`The interlock formation or crimping is readily accomplished by a two-
`piece die 40 as shown in Figure 7 or the like.
`
`Figure 8 demonstrates that more than a two-piece mounting body
`affangement may be used if desired. In this embodiment, the mounting body is
`comprised of three spaced bodies 30a, 30b and 30c on the inner 26. Preferably in
`the embodiments of Figures 6 and 8, the mounting bodies will be ring-like in shape
`or cylindrical in shape although other configurations will be readily apparent to those
`familiar with this art.
`
`10
`
`The above Examples and disclosure are intended to be illustrative and
`not exhaustive. These examples and description will suggest many variations and
`alternatives to one of ordinary skill in this art. All these alternatives and variations
`15 are intended to be included within the scope of the attached claims. Those familiar
`with the art may recognize other equivalents to the specific embodiments described
`herein which equivalents are also intended to be encompassed by the claims attached
`
`hereto.
`
`20
`
`'#t
`
`I
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 13
`
`

`

`What is claimed is as follows:
`
`-7-
`
`stent delivery system comprising:
`
`receiving the stent o{ the expandable inflatable means for radial expansion of the
`stent upon inflation {f the inflatable means, the mounting and retaining means
`including at least onp mounting body carried on and surrounding the shaft inside the
`10 inflatable means whfreby the diameter of the shaft and inflatable portion are
`increased at the distll part for facilitating the mounting and retaining of the stent.
`2.
`The stent delivery system of claim 1 wherein the mounting
`body is of a material which resiliently deforms under radial pressure.
`3.
`The stent delivery system of claim 2 wherein the material is
`
`25
`
`30
`
`9. $. ,t nt delivery bystem of claim 1 including a pair of srops,
`
`15 elastomeric.
`4. rr,l st.nt delivery system of claim 2 wherein the material
`Srb,HEf
`comprises HDPE.
`\
`\
`5.
`Thd stent delivery system of claim 2 wherein the material
`n /l comprises silicone.
`6.
`rne/tentdelivery system of claim 1 wherein rhe mounting
`)UlfU]"]
`/
`bdtry configuration inclu/es at least one separation whereby the flexibility of the
`body and catheter is in/reaseA.
`7.
`it, ur* delivery system of claim 6 wherein the separation is
`in the form of a spiral.
`8.
`The stent delivery system of claim 1 wherein the stent is
`.
`crimped to the mounting and retaining means for delivery.
`UASO]
`'
`.ach of which is respe{ively positioned at opposite ends of the stent and carried by
`the shaft inside ttre inn{taUle means.
`10. The stent delivery system of elaim 9 wherein the stops are
`conical in shape.
`,r. The stent delivery ,rurrrlof claim 1 including marker bands
`I
`p&itioned proximally ancl distally of the stent.
`
`n./\
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`n. \-,$A
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`I
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 14
`
`

`

`-8-
`/
`/
`12. T/e stent delivery system of claim 1 wherein the inflatable
`means comprises a bdlloon.
`.
`./
`.)--/ ^
`Ll: The stent delivery system of claim 1 including a stop
`end of the catheter and carried by the shaft inside the
`
`-t
`
`4. A stent delivery system comprising:
`catheter having a shaft and expandable inflatable means associated
`part of the shaft and including mounting and retaining means for
`to be delivered upon expansion of the inflatable means, the
`
`ining means including at least one mounting body inside the
`
`and carried and/or surrounding the shaft, and
`
`crimped to the inflatable means and the mounting body such
`portions of the stent are deformed to a diameter less than that of
`y whereby the stent is interlocked with the mounting body until
`stent and inflatable means to prevent accidental movement of the
`/)
`
`during delivery.
`
`10 mounting and
`inflatable mea
`
`that opposite
`
`the mounting
`15 expansion of
`stent along the
`
`diameter and
`
`between the mounting bodies. / 5
`fu* The stent delivery system of claim l{-wherein the stent is
`,
`il^ ,,ge\erally tubular
`hillaL \
`{(
`
`18
`
`in shape and the mounting bodies are ring-like.
`The stent delivery system of claim 14 wherein at least three
`are included and the stent is crimped to a lesser diameter
`
`^#^mountinsr
`between tne fai*-s
`l_7
`lne srcnt oellvery sysrcm or clalm ur'wnel
`Lg r
`generally tuby'hr in shape and the mounting bodies are ring-like.
`
`catheter comprising { shaft, a balloon associated with a distal portion of the shaft for
`iving a stent, and means for inflating the balloon, the shaft including at least
`one, mounting body fanied on the shaft inside the balloon whereby the diameter of
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 15
`
`

`

`-9-
`
`the shaft is increasedf inrio,
`
`the balloon to facilitate mounting of a stent to the
`tqt;.I
`catheter over the uaupon.
`The catheter of claim 'jft'whereinthe mounting body is of a
`2g2f,
`material which resiliently deforms under radial pressure.
`The catheter of claim &o*hrrrinthe material is elastomeric.
`\lk.
`23. D*. catheter {ctarm2l^wherein the material is HDPE.
`' I
`frH
`rheca
`theter of claim Wwhercinthe material is silicone.
`"AH.
`The catheter of claim /fl *n"r"inthe mounting body is
`configured with at least one separation whereby trackability of the catheter is
`
`5
`N^Tft{-l
`
`?_rl
`The catheter of claim 28 $hercinthe separation is in a spiral
`
`IT
`
` catheter of claim 2_0 including a pair of spaced stops.
`tnL catheter of claim h%n"rrinthe stops are conical in
`
`10 improved. {
`U6.
`configuration.
`
`s"VP$1 "'
`'xl 28
`
`15
`
`shape.
`
`pr^N$V-lrn. The[catheter of claim 20including spaced marker bands.
`(v
`The catheter of claim ffin"r"n the mounting body is
`V+n
`cylindrical in shape.
`lq
`The catheter of claim ]fi wherein at least two spaced mounting
`io-+r'
`2A bodies are included.
`3o
`gle.
`The catheter of claim 3i wherein the mounting bodies are ring-
`tf
`/r"?a
`included. A"--
`The catheter of claim 7t wherein the mounting bodies are ring-
`
`The catheter of claim 2O wherein at least three spaced
`
`like.
`
`mounting bodies are
`,25
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`like.
`
`cL%,q
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`30
`
`F : \WPWORK\OFA\ffi 50- APP ;l 22
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 16
`
`

`

`-10-
`
`Abstract of the Disclosure
`
`STENT DELTVERY SYSTEM
`A stent delivery system to facilitate introduction and placement of a
`5 stent, including a catheter having an expandable distal portion constructed and
`arranged for expanding the outer diameter of the catheter from a contracted state to
`an expanded state: a stent positioned around the distal portion of the catheter having
`
`a contracted condition and being expandable to an expanded condition, and being
`sized in the contracted condition to closely surround the catheter in the contracted
`10 state, the expandable distal portion of the catheter including a balloon within which
`there is included on the catheter shaft at least one body of a diameter larger than the
`catheter shaft to which the stent and balloon are fitted, as by crimping, for holding
`the stent in place until it is released therefrom by expansion of the balloon.
`
`15
`
`F:\WPWORK\OFA\6050-APP.722
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 17
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 19
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 22
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 24
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 25
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`st\r#; UNITED STATEV'OEPA TiMENM OF COMMERCE
`
`Patent and Tnademank,clffice
`Address: C0MMISSIONEB OF PATENTS AND TRADEMARKS
`Washington, D.C. 20231
`
`:,
`
`!!$tu%s
`
`APPLICATIONNUMBER I
`
`FIUNGDATE
`
`FIBST NAMED APPUCANT
`
`ATTY. DOCKET NOJTITLE
`
`i..:li;1.r',:'1i1;1. i$i.i
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`pa6 6a16i) tl ii t)
`NOTICE TO FILE MISSING PARTS OF APPLICATION rr i:;,..:i..j.,/1.rrii
`NLING DATE GRANTED
`
`An Application Number and Filing Date have been assigned to this application. However, the items indicated
`below are missing. The required items and fees identified below must be timely ryblnijt$ ALONG WITH
`THn PAYIilEITIT OF A SITRCIIARGE for items 1 and 3-6 only of fi-t/J2. F for large entities or
`$-forsmallentitieswhohavefiledaverifiedstatementclaimingsuchs[atus.Thesurchargeissetforthin
`37 cFR 1.16(e).
`If all required items on this form are filed within the penglseJ.|ie)yct, thefotal amount owed by applicant as a FWd
`entity, flsmallentity (verifiedstatementfiled), is $JJ K-d-. n/
`Applicant is given ONE MONTE FROM THE DATE OF THIS LDTTER, OR TWO MONTHS FROM THE
`FILING DATE of this application, WHICHEVER IS LATER, within which to file all required items and pay any fees
`required above to avoid abandonment. Extensions of time may be obtained by frling a petition accompanied by the
`extension fee under the provisions of 37 CFR 1.136(a).
`
`insuffrcient. Applicant as a ! large entity n small
`rte the bagic filing fee.
`d.*de"entity, tr small entity, including any
`- required multiple dependent claim fee, are required. Applicant must submit the additional claim
`fees or cancel the additional claims for which fees are due.
`3. tr The oath or declaration:
`n is missing.
`E does not cover the newly submitted items.
`
`An oath or declaration in compliance with 37 CFR 1.63, identifying the application by the above
`Apptcation Number and FilingDate is required.
`4. tr fire oath or declaration does not identify the application to which it applies. An oath or declaration
`in compliance with 37 CFR 1.63, identifying the application by the above Application Number and
`Filing Date, is required.
`5. tr fire signature(s) to the oath or declaration idare: - missing; n by a person other than the inventor
`or a person qualilied under 37 CFR L.42, t.43, or 1.47. A properly signed oath or declaration in
`compliance with 37 CFR 1.63, identifying the application by the above Application Number and
`Filing Date, is required.
`6. tr The signature of the following joint inventods) is missing from the oath sr declaration:
`
`An oath or declaration listing the names of all inventors and signed by
`' the omitted inventor(s), identifying this application by the above Application Number and Filing
`Date, is required.
`7. n The application was filed in a language other than English. Applicant must file a verified English
`under 37 CFR 1.17(k), unless this fee has
`trahslation ofthe application and a fee of$
`already been paid.
`8. n A$
`(37 CFR 1.21(m)).
`9. I Your filing receipt was mailed in error because your check was returned without payment.
`10. tr The application does not comply with the Sequence Rules. See attached Notice to Comply with
`Sequence Rules 37 CFR 1.821-1.826.
`11.1 Other.
`
`processing fee is required since your check was returned without payment.
`
`Direct the response to Box Missing Part and refer any questions to the Customer Seryice Center
`at (703) 308-L202.
`
`A eopy of this notiee MUSf be returned witle. the response.
`
`roRM PDO.1633 (REV. r r-e4)
`
`OFFICE COPY
`;;"'.-
`l#*:r'
`,,-..'*,*"
`
`:-'
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1025 - Page 26
`
`

`

`ryrg;r ,/ag_/o*o?b
`
`@N-?%
`14 &3
`& 19S6 a*,
`\for**sP
`
`IN TIIE TJNITED STATES PATENT AND TRADEMARK OFFICE
`
`In Re Application Of:
`
`Ser. No:
`
`Louis G. Ellis, Andrew J. Dusbabek, Christopher R.
`Larson, Terry V. Brown
`
`08/702,1,50
`
`August 23,1996
`
`Title of Invention:
`
`STENT DELIVERY SYSTEM
`
`Box Missing Part
`Assistant Commissioner For Patents
`Washington, DC2023l
`
`PATENT
`
`U}
`
`F\
`
`{J
`'41 O
`ed$
`.{f{}
`cr fjd
`
`d)ri)
`
`t4't
`
`I
`{."l s
`f"l (1
`'-:l
`xfq
`Docket No:SG[2-6050
`dd
`ff,J m
`
`TRANSMITTAL LETTER
`
`1.
`In regard to the above-identified application, we are submitting the attached:
`Notice of Missing Parts Including: Assignment Cover Sheet and Assignment and Certificate Under 37 CFR
`3.73(b); 3 Pg Declaration;