•
`
`• 330/
`
`-J.2-
`~
`P::i~1
`~~ s.s(/
`t?;Cf~~'~~
`, i ~ A: . ~
`.. -'
`,
`IN THE UNITED STATES PATENT AND T DEMARK OFFICE
`~~ f~:t~lication of: JAMES E~IS ~ ~i~: ~ f":!" S
`
`(~
`
`~p\
`
`. Serial No.: ,08/483,291 V
`
`Filing Date: June 7, 1995
`
`'
`
`__
`
`~
`
`~,
`
`Group Art Unit: 331
`
`Pasadena, California
`
`AMENDMENT
`
`Washington, D. C.
`
`Sir:
`
`MA~' 2
`
`In response to the Office Action of October 29, 1996, please amend the
`
`above-identified Application as follows:
`
`IN THE SPECIFICATION
`
`---~...::=-----
`At page 6, line 4, after the des'Cr(pti~n- of Figures 3-6 added by t'he
`
`Preliminary Amendment, please add the following:
`
`- Figure 7 shows a guide catheter, transport catheter, and compacted wire
`
`coil stent according to the present invention,--
`
`_----L-' ~...A::::=:=ti...!p:.:a:.!:g!..:e~1 7..:.-,~at:...t.::.h.:.:e:..-e:.:n:..::d=-=o.::..f ..::.li:.:.ne=-=2:.:3~i:.:..:n.::.se::.:rt...:..:...· ->Accord i ng to Dotter et a I.,
`
`Radiology 147: 259-260, a compacted nitinol coil is readily positioned in a narrowed
`
`C: \WP51 \MCP\TEMP\9438-1.AMD
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 1
`
`
`
`• 330/
`
`-J.2-
`~
`P::i~1
`~~ s.s(/
`t?;Cf~~'~~
`, i ~ A: . ~
`.. -'
`,
`IN THE UNITED STATES PATENT AND T DEMARK OFFICE
`~~ f~:t~lication of: JAMES E~IS ~ ~i~: ~ f":!" S
`
`(~
`
`~p\
`
`. Serial No.: ,08/483,291 V
`
`Filing Date: June 7, 1995
`
`'
`
`__
`
`~
`
`~,
`
`Group Art Unit: 331
`
`Pasadena, California
`
`AMENDMENT
`
`Washington, D. C.
`
`Sir:
`
`MA~' 2
`
`In response to the Office Action of October 29, 1996, please amend the
`
`above-identified Application as follows:
`
`IN THE SPECIFICATION
`
`---~...::=-----
`At page 6, line 4, after the des'Cr(pti~n- of Figures 3-6 added by t'he
`
`Preliminary Amendment, please add the following:
`
`- Figure 7 shows a guide catheter, transport catheter, and compacted wire
`
`coil stent according to the present invention,--
`
`_----L-' ~...A::::=:=ti...!p:.:a:.!:g!..:e~1 7..:.-,~at:...t.::.h.:.:e:..-e:.:n:..::d=-=o.::..f ..::.li:.:.ne=-=2:.:3~i:.:..:n.::.se::.:rt...:..:...· ->Accord i ng to Dotter et a I.,
`
`Radiology 147: 259-260, a compacted nitinol coil is readily positioned in a narrowed
`
`C: \WP51 \MCP\TEMP\9438-1.AMD
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 1
`
`
`
`· ..
`
`'.
`
`PATENT
`9438-1
`
`arterial segment and then expanded to its original form with a luminal diameter
`
`approximately equal to that of the adjacent, relatively normal, blood vessel. Expansion of
`
`the coil anchors it against the slightly stretched, but otherwise intact, surrounding blood
`
`vessel. Several means have been found to facilitate the placement of the nitinol coil stent.
`
`One of the simplest involves the use of conventional catheterization techniques to position
`
`a large-bore guide catheter 102 (as shown in Fig. 7) close to the site of intended stent 103
`
`placement. The coil 103 is wedged-loaded over the inner end of an inner coaxial transp.,grt
`
`catheter 104 that has a closed tip and multiple side holes evenly spaced within the
`
`surrounding nitinol coil stent.
`
`According to Cragg et aLi Radiology 147: 261-262, straightened nitinol coils
`
`were passed through a 10-F Teflon catheter in the abdominal aorta. The nitinol coils were
`
`fastened to a threaded guiding wire to allow accurate placement after being deposited in
`
`the aorta. Once the wire was extruded from the catheter, precise placement of the newly
`
`formed coil was accomplished by advancing or withdrawing the guide wire in the aorta.
`
`Detachment of the coil was achieved by unscrewing the guide wire from the distal end of
`
`the coil. After coil placement, the catheter and guide wire were withdrawn and the
`
`arteriotomy was CIOS:)
`
`DRAWINGS
`
`Please add Fig. 7 to the drawings.
`
`C, \WPSl \MCP\TEMP\9438-1.AMD
`
`2
`
`30
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 2
`
`
`
`•
`
`PATENT
`9438-1
`
`IN THE CLAIMS
`
`Cancel claims 11-20, 22, and-:24, without prejudice to presenting these
`
`•
`/ / --
`/" ---
`
`claims in a continuation application.
`
`•
`
`Claim 23, line 2, delete "graft".
`
`/~
`Claim 25, line 2, delete "the" (first occurrence).
`
`---~
`
`Please amend claim 21 as follows:
`
`(Amended) A medical device for insertion into a mammalian body,
`
`the device comprising
`
`li!l
`
`ill
`
`[(i)) a hollow placement device.,;. [and]
`
`[Iii)] a memory alloy element formed at least partly from pseudoelastic
`
`shape-memory alloy, the alloy displaying reversible stress-induced martensite at about body.
`
`temperature such that it has a stress-induced martensitic state and an austenitic state, the
`
`memory alloy element having (i) a deformed shape when the alloy is in its stress-induced
`
`martensitic state and (ii) a different unstressed shape when the alloy is in its austenitic
`
`state; and
`
`.lij
`
`a guide wire:
`
`the memory alloy element being within the hollow placement device, and the
`
`placement device being guidable by the guide wire, the hollow placement device stressing
`
`the memory alloy element at a temperature greater than the As of the alloy so that the
`
`memory alloy element is in its deformed shape,
`
`c: \WP51 \MCP\TEMP\9438-1.AMD
`
`3
`
`Jl
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 3
`
`
`
`"
`
`•
`
`•
`
`PATENT
`9438-1
`
`wherein the memory alloy element can be extruded from the hollow
`
`placement device by the guide wire at a temperature greater than the As of the alloy to
`
`transform at least a portion of the alloy from its stress-induced martensitic state so that the
`
`memory alloy element transforms from its deformed shape to its unstressed shape, and
`
`wherein the [device is adapted] alloy is selected so that the transformation can occur
`
`without any change in temperature of the placement device or the memory alloy element.
`
`~dd the following claims to the application.
`
`~I
`
`----
`~ '{p
`jet:
`
`A medical device which comprises:
`
`(a)
`
`a stent for endarterial placement within a human body so that the
`
`stent is substantially at human body temperature, the stent comprising a shape memory
`
`alloy which displays stress-induced martensite behavior at body temperature; and
`
`(b)
`
`a restraint holding the stent in a deformed configuration at a
`
`temperature less than the body temperature of the human for endarterial positioning of the
`
`. stent within the human body in its deformed configuration, the deformation occurring
`
`through the formation of stress-induced martensite;
`
`wherein the stent is sufficiently deformed that when the stent is at human
`
`body temperature removal of the restraint from the stent, without change in temperature of
`
`the device, releases at least a portion of the stent from its deformed configuration.
`
`7..,
`.
`(,0
`'zr. A device as claimed in .,a.tr,in which the restraint is hollow, and the
`
`stent is positioned at least partially within the restraint.
`
`C: \WPSl \MCP\TEMP\9438-1.AMD
`
`4
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 4
`
`
`
`•
`
`•
`
`.,
`<.0
`A device as claimed in claim 2.8 or ~ in which the restraint is a
`
`PATENT
`9438-1
`
`catheter.
`
`A device as claimed in claim .~or 1, in which the stent has a
`
`transverse dimension and a longitudinal dimension, and wherein the stent is deformed by
`
`·its transverse dimension being reduced, and wherein the restraint prevents transverse
`
`expansion of the stent.
`
`~
`The device of claim ~, wherein the shape memory alloy element is
`
`.
`
`sufficiently deformed that removal of the restraint from the shape memory alloy releases at
`
`least a portion of the shape alloy element from its deformed configuration without change
`
`in state of the restraint.
`
`A medical device suitable for placement within a mammalian body for
`
`treatment of the mammalian body,' the device comprising:
`
`(a)
`
`a stentformed at least partly from a pseudoelastic shape-memory
`
`alloy, the alloy having a reversible stress-induced martensitic state and an austenitic state,
`
`the memory alloy element having (i) a deformed shape when the alloy is in its stress-
`
`induced martensitic state and (ii) a different, unstressed shape; and
`
`(b)
`
`restraining means engaging and stressing the stent at a temperature
`
`less than the body temperature of the mammal and greater than the As of the alloy for
`
`positioning the stent within the mammalian body while the stent is in its deformed shape;
`
`wherein the alloy is selected so that removal of the restraining means from
`
`the stent at a temperature greater than the As of the alloy when ·the device is placed within
`
`C: \WPSl.\MCP\TEMP\9438-1..AMD
`
`5
`
`33
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 5
`
`
`
`•
`
`•
`
`PATENT
`9438-1
`
`the mammalian body, transforms at least a portion of the alloy from its stressed-induced
`
`martensitic state so that the stent transforms from its deformed relatively straightened
`
`shape towards its unstressed relatively coiled shape, without any change in temperature of
`
`the restraining means or the stent being required for the transformation of the alloy.
`
`A medical device for treatment of a mammalian body, the device
`
`comprising:
`
`(a)
`
`a memory alloy stent formed at least partly from a pseudoelastic
`
`shape-memory alloy, the alloy displaying reversible stress-induced martensite at about the
`
`mammalian body temperature such that it hasa stress-induced martensitic state and an
`
`austenitic state, the memory alloy stent having (i) a deformed relatively straightened shape
`
`. when the alloy is in its stress-induced martensitic state and (ii) a different unstressed
`
`relatively coiled shape; and
`
`(b)
`
`a hollow restraining member with the memory alloy stent being
`
`within the restraining member, the restraining member engaging and stressing the memory
`
`alloy stent at a temperature less than the body temperature of the mammal and greater
`
`than the As of the alloy for positioning the memory alloy stent within the human body
`
`while the memory alloy coil stent is in its deformed relatively straightened shape;
`
`wherein the restraining member and the memory alloy stent are movable
`
`relative to each other to transform at least a portion of the alloy from its stress-induced
`
`martensitic state at a temperature greater than the As of the alloy so that the memory alloy
`
`element transforms from its deformed shape towards its unstressed relatively coiled shape,
`
`and wherein the alloy is selected so that the transformation can occur without any change
`
`in temperature of the restraining member or the memory alloy coil stent.
`
`c: \WP5l \MCP\TEMP\9438-1.AMO
`
`March 28. 1997
`
`Edwards Exhibit 1018, p. 6
`
`
`
`•
`
`•
`
`PATENT
`9438-1
`
`A medical device suitable for placement within a mammalian body for
`
`treatment of the mammalian body, the device comprising (i) a restraint, and (ii) a coil stent
`
`formed at least partly from a pseudoelastic shape-memory alloy,
`
`the alloy displaying reversible stress-induced martensite by virtue of
`
`being above its As and above its Ms and below its Md at about body temperature;
`
`such that it has a stress-induced martensitic state and an austenitic
`
`state, the element having (i) a relatively straightened shape when the alloy is in its stress-
`
`induced martensitic state and (ii) a different relatively coiled shape;
`
`wherein the restraint is (i) stressing the coil stent at a temperature
`
`less than the body temperat'ure of the mammal for placement of the coil stent in its
`
`relatively straightened shape in the mammalian body and (ii) is capable of being at least
`
`partially removed from the coil stent while the coil stent is within the body at the body
`
`temperature and the coil stent is therefore at an operating temperature greater than the As
`
`and Ms and below the Md of the alloy,
`
`such removal of the restraint causing at least a portion of the alloy to
`
`transform from its stress-induced martensitic state to its austenitic state so that the coil
`
`stent spontaneously transforms from its relatively straightened shape towards its relatively
`
`coiled shape,
`
`and such transformation can occur without a change in temperature
`
`of the restraint or of the coil stent from the operating temperature.
`
`A medical device comprising:
`
`(a)
`
`a wire stent ,formed at least partly from a pseudoelastic shape
`
`memory alloy, the alloy displaying reversible stress-induced 'martensite at about human'
`
`C: \WPSl \MCP\TEMP\9438-1,l\MD
`
`7
`
`~
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 7
`
`
`
`•
`
`•
`
`PATENT
`9438-1
`
`body temperature such as it has a deformed shape when the alloy is in its stress-induced
`
`martensitic state and a different unstressed shape when the alloy is in its austenitic state;
`
`and
`
`(b)
`
`a restraint stressing the wire stent at a temperature greater than the
`
`. As of the alloy so that the wire stent is in its deformed shape,
`
`wherein the stent can be disengaged from the restraint upon placement in a
`
`human so that the stent transforms from its deformed shape to its unstressed shape, and
`
`wherein the alloy is selected so that the transformation can occur without
`
`any change in temperature of the restraint or the wire stent.
`
`Ik The device of claim k .~ .~ or ~ wherein the mammalian body
`
`is a humari body.
`
`catheter.
`
`I
`The device of claim J1, w'herein the hollow placement device is a
`
`:I--
`~---'
`The device of claim pi, including, a guide wire for endarterial
`~
`
`placement of the stent graft.
`
`11
`38":"
`
`4? II
`ic1 I~
`I "
`The device of claim 2¥.M, ~ J.5 or . .J.4', including a guide wire for
`
`endarterial placement of the stent.
`
`wherein the radially expanded shape is a coil
`
`C: \WPSl \MCP\TEMP\9438-1.AMD
`
`8
`
`3(P
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 8
`
`
`
`•
`
`PATENT
`9438-1
`
`The device of claim ~ wherein the transformation of the alloy
`
`occurs without any change in state of the restraining means.
`
`"
`
`IE lie
`~t()
`.
`,,,
`~ The device of claim j¥, ~ or ;34, wherein the transformation of the
`
`alloy occurs without any change in state of the restraint.
`
`jJ
`Mo.
`
`I l.sl~
`Ii
`The device of claim if, .32': 3.((, or ;14, wherein the restraint is a
`
`catheter.
`
`stent.
`
`~The de~f claim 39 wherein the stent is within the catheter.
`
`L3
`j/.
`~ The device of claim}.f' wherein the restraining means is a catheter.
`
`I~
`Jt:f5.
`
`Jl-
`%
`
`13
`The device of claim ~ wherein the stent is within the catheter.
`
`I S
`I ". {5
`The device of claim j6, ;3-(, ~ or }4 wherein the stent is a coil
`
`REMARKS
`
`Claims 21, 23, 25, and 26-46 are in this application. Claims 11-20, 22, and
`
`24 are canceled by this amendment. Claims 26-46 are added by this amendment. Claims
`
`11-14,21,23, and 25 were rejected under 35 U.S.C. § 112. Claim 11 was rejected under
`
`35 U.S.C. § 102. Claims 11-14, 21,23, and 25 were rejected under 35 U.S.C. § 103.
`
`Claims 21, 23, and 25 were rejected for obviousness-type double patenting.
`
`c: \WPSl \MCP\TEMP\9438-1.AMD
`
`9
`
`31
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 9
`
`
`
`•
`
`PATENT
`9438-1
`
`In view of the amendments to the clai'ms, and the remarks below, it is
`
`respectfully submitted that all of the claims in the application are in condition for
`
`allowance. Accordingly, reexamination, reconsideration, and allowance are respectfully
`
`requested.
`
`ENTRY OF AMENDMENTS
`
`Entry of the amendments to the specification, the new drawing, and the new
`
`claims is respectfully requested. They raise no issues of new matter.
`
`In particular, the new drawing, the description of the drawing, and the
`
`addition to page 17 of the specification are taken from two articles that were incorporated
`
`in the original specification by refere~ce at page 17, lines 16-20, namely Radiology,
`
`Volume 47, pages 259-260 and pages 261-3 (1983). For the convenience of the
`
`Examiner, copies of those documel"!.ts are provided herewith. Adding a drawing and
`
`language to the specification already incorporated by reference does not raise issues of
`
`new matter. See MPEP § 804.01.
`
`NEW CLAIMS
`
`Allowance of the new claims is believed appropriate. These claims
`
`correspond to, and generally are narrower versions of claims that were allowed in the
`
`parent application, with the correspondence as follows:
`
`SERIAL NO. 07/956,953
`
`SERIAL NO. 08/483,291
`
`19,20,21,25,26,27,28,57
`
`26,27,28,29,30; 31, 32, 33
`
`C: \WP51 \MCP\TEMP\9438 -l.AMD
`
`10
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 10
`
`
`
`•
`
`•
`
`PATENT
`9438-1
`
`For the same reasons the claims were allowed in the parent application, it is
`
`respectfully submitted they, should be 'allowed in this application, as well as the claims
`
`, dependent therefrom. It is also believed that the other claims presented herein are likewise
`
`allowable in view of commonality of allowable subject,matter.
`
`DRAWING OBJECTION
`
`The drawings were objected to for failure to show a stent graft. This
`
`rejection has been obviated by the addition of Fig. 7.
`
`REJECTION UNDER 35 U.S.C. § 112
`
`Claim 11-14, 21, 23, and 25 were rejected under 35 U.S.C. § 112. Claims
`
`11-14 have been cancelled, without prejudice, subject to their presentation in a
`
`continuation application. As to the objections to claims 21, 23, and 25, it is respectfully
`
`submitted that the amendments to these claims obviate the objections raised.
`
`Accordingly, it is respectfully submitted that by the amendments to the
`
`claims, the rejection under 35 U.S.C. § 112 has been obviated.
`
`REJECTION OVER QUIN
`
`Claims 11-14 were rejected over Quin U.S. Patent No. 4,505,767.
`
`However, as noted by the Examiner, the present application claims priority from
`
`Application Serial No. 541,852 which was filed on the same day as the Quin application.
`
`Since the specification filed herewith is identical to that originally filed, the claim of priority
`
`is good. Moreover, since all of the claims submitted under examination are supported by
`
`, c: \WPSl \MCP\TEMP\943S-l.AMD
`
`11
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 11
`
`
`
`;
`
`,
`
`•
`
`•
`
`PATENT
`9438-1
`
`the specification as originally submitted and contain no new matter, they are all entitled to
`
`the priority date of October 14, 1983. Accordingly, the rejection should not have been
`
`made. However, the rejection has been obviated by cancellation of the claims, without
`
`prejudice.
`
`REJECTION UNDER 35 U.S.C. § 103
`
`Claims 21, 23, and 25 were rejected over the combination of Balko et al.
`
`Patent No. 4,512,338 and Seader (Encyclopedia of Chemical Technology publication).
`
`This rejection, is respectfully traversed.
`
`Balko describes a stent made out of nitinol, i.e., essentially what is described
`
`in the Radiology articles that are discussed in the present application. The Office Action
`
`appears to suggest that the basis of the rejection is that all nitinol alloys exhibit SIM
`
`behavior, and thus the invention is obvious.
`
`Firstly, it should be noted the references relied upon herein were before the
`
`Patent Office and claims broader than those presented herewith were allowed. The claims
`
`presented herein are due to a species election requirement in the parent application.
`
`If the
`
`/
`
`generic invention is unobvious, then the species likewise must be unobvious.
`
`Secondly, the rejection is based on a false assumption that all nitinol alloys
`
`would be effective in a medical device for use in mammalian bodies. This is not accurate.
`
`As stated in the Quin patent:
`
`C, \WPSl \MCP\TEMP\9438-1 ,AMI)
`
`12
`
`March 28, 1997
`
`Q
`
`Edwards Exhibit 1018, p. 12
`
`
`
`.
`
`;
`
`•
`
`•
`
`PATENT
`9438-1
`
`"The extent of the temperature range over which
`
`. SIM is seen and the stress and strain ranges for
`
`the effect vary greatly with the alloy." (Column
`
`2, lines 31-34)
`
`Quin goes on to say that her invention, which is incorporated by reference in the present
`
`application, was a discovery that "the addition of appropriate amounts of vanadium to
`
`nickel/titanium shape memory alloys permits the production of workable alloys exhibiting
`
`st~ess-induced martensite in a physiologically acceptable temperature range' ... " (column
`
`3, lines 55-:59). There is no suggestion in Balko that his alloy should be selectedto have
`
`SIM behavior in a physiologically useful'temperature range ..
`
`Furthermore, there is no suggestion in either of these references to actually
`
`use an SIM alloy to take advantage of its properties.
`
`In fact, the references teach away, in
`
`that Balko et al. requires a temperature change to effect a change in state. A difficulty
`
`with such an approach is easily envisioned, in that as a coil stent is warmed up to reach
`
`body temperature as it is inserted, it can prematurely expand before it is removed from the
`
`restraint, thereby interfering with removal. Optionally, external heating is required, which
`
`introduces its own complications (see Balko et aI., column 5, lines 57 et seq.). The
`
`simplicity of the present invention, where the coil stent achieves its desired configuration
`
`without the requirement of any external heating or cooling provides predictability and
`
`simplicity in the operating theater, advantages not taught or suggested by either of these
`
`references.
`
`c: \WPSl \MCP\TEMP\943B-l.AMD
`
`13
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 13
`
`
`
`•
`
`•
`
`PATENT
`9438-1
`
`Accordingly, removal of the rejection under 35 U.S.C. § 103 is respectfully
`
`requested.
`
`DOUBLE-PATENTING REJECTION
`
`Claims 21, 23, and 25 were rejected for double-patenting in view of U.S.
`
`Patent No. 5,007,957. However, device claims were restricted out of the '957 application
`
`as a result of a restriction requirement. Attached is a copy of the Office Action.
`
`Accordingly, the double-patenting rejection is inappropriate. See MPEP § {806.05(f).
`
`In view of the above remarks, a notice of allowance is respectfully
`
`Respectfully submitted,
`
`SHELDON & MAK
`
`requested.
`
`Date
`
`225 South Lake Avenue, 9th Floor
`Pasadena, California 91101
`(818) 796-4000
`
`C:\WPS1\MCP\TEMP\943S·1.AMD
`
`14
`
`March 28, 1997
`
`Edwards Exhibit 1018, p. 14
`
`
`
`•
`
`-.
`
`%I.EEE.E.EiI
`
`Fig 7.
`
`Edwards Exhibit 1018, p. 15
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