DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 05/26/26, have been fully considered but they are not persuasive.
On pages 7-10 regarding prior art rejections Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Claim Objections
Claim 1-10 and 17-20 are objected to because of the following informalities:
Claims 1-10 are objected to for referring to “a stent delivery catheter assembly” but it is believed hyphens should exist within this phrase (e.g. stent-delivery catheter assembly).
Claim 10 is objected to for referring to “stent deployment catheter assembly” when it appears a word is missing before it (e.g. “a”).
The claim is further objected to for referring to “a self-expanding stent” with improper antecedent basis.
The claim is further objected to for referring to “a radial outward directed force” when it is believed it should be worded similarly to “a radially outwardly-directed force”.
Claims 17-20 are objected to for referring to “a prosthesis delivery catheter assembly” when it is believed a hyphen is needed within this name (e.g. prosthesis-delivery catheter assembly).
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 17-20, 1-2, 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. (US 6425898) hereinafter known as Wilson in view of Hoo et al. (EP 1836998 A1) hereinafter known as Hoo.
Regarding claim 17 Wilson discloses a prosthesis delivery catheter assembly (Abstract) comprising:
an outer sheath (40),
an inner sheath coaxially disposed within the outer sheath (10),
but is silent with regards to there being an expandable pliant member surrounding a distal portion of the inner sheath which is configured to engage a self-expanding member.
However, regarding claim 17 Hoo teaches a prosthesis delivery catheter assembly which comprises an expandable pliant member (30; [0013] the film 30 is made of a pliant polymer material) surrounding a distal portion of a sheath (Figure 4 shows sheath 80 with its distal part being surrounded by the pliant member 30), wherein the pliant member is configured to engage a self-expanding member (Figures 4-5 item 20; Abstract).
Wilson and Hoo are involved in the same field of endeavor, namely delivery assemblies. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the assembly of Wilson to include the pliant member surrounding a self-expanding member as is taught by Hoo in order to provide a mechanism to frictionally stabilize the stent during deployment, thus easing delivery, and to optimize the delivery profile of the stent thus allowing smoother delivery through narrow vessels.
Regarding claim 18 the Wilson Hoo Combination teaches the assembly of claim 17 substantially as is claimed,
wherein the Combination further teaches the self-expanding prosthesis is configured to imprint around a portion of an outer surface of the pliant member (the self-expanding prosthesis is not positively claimed, and so this does not appear to further limit the claimed assembly).
Regarding claim 19 the Wilson Hoo Combination teaches the assembly of claim 17 substantially as is claimed,
wherein the Combination further teaches a length of the pliant member is equal to or less than that of the prosthesis (since the prosthesis is not positively claimed, this does not materially affect the claimed assembly).
Regarding claim 20 the Wilson Hoo Combination teaches the assembly of claim 17 substantially as is claimed,
wherein the Combination further teaches the pliant member limits longitudinal displacement of the prosthesis (since the prosthesis is not positively claimed, this does not materially affect the claimed assembly).
Regarding claim 1 Wilson discloses a stent delivery catheter assembly (Abstract) comprising:
an outer sheath (40),
an inner sheath coaxially disposed within the outer sheath (10),
and a self-expanding stent (Abstract),
but is silent with regards to the assembly including an expandable member surrounding a distal portion of the inner sheath and the self-expanding stent surrounding the expandable member,
and a sleeve surrounding and selectively restraining the stent, so that the expandable member is configured to rupture the sleeve to allow the stent to radially self-expand to an intermediate expanded diameter less than a final expanded diameter.
However, regarding claim 1 Hoo teaches a stent delivery catheter assembly which comprises an expandable member (Figures 4-5 item 90 balloon) surrounding a distal portion of a sheath (Figures 4-5 item 80),
a self-expanding (Abstract) stent (Figures 13-5 item 20) surrounding the expandable member (Figures 4-5 shows the stent 20 surrounding the balloon 90 during delivery and deployment), and
a sleeve surrounding and selectively constraining the self-expanding stent (Figures 1-5 item 30; [0017] the sleeve constrains the stent until rupture),
wherein the expandable member is configured to rupture the sleeve allowing the stent to radially self-expand to an intermediate expanded diameter less than a final expanded diameter of the stent ([0017]; regarding the requirement that the stent must expand to an intermediate diameter between its delivery configuration and the final expanded diameter, the Examiner points out that upon rupture of the film 30 and self-expansion of the stent 20, there are many “intermediate expanded diameters” in the transition between the two states).
Wilson and Hoo are involved in the same field of endeavor, namely delivery assemblies. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the assembly of Wilson to include the rupturable sleeve surrounding the self-expanding stent as is taught by Hoo in order to increase placement accuracy of the stent during deployment, thus resulting in an easier deployment of the cardiac interventionalist.
Regarding claim 2 the Wilson Hoo Combination teaches the assembly of claim 1 substantially as is claimed,
wherein Hoo further teaches a length of the expandable member is equal to or greater than a length of the stent (Figure 5 shows balloon 90 having a length at least equal to that of the stent 20).
Regarding claim 6 the Wilson Hoo Combination teaches the assembly of claim 5 substantially as is claimed,
wherein Hoo further teaches the expandable member is configured to limit longitudinal displacement of the stent when the outer sheath is proximally withdrawn (this is considered inherent since Hoo teaches the stent is crimped onto the expandable member ([0017]), and friction inherently limits movement of two elements adjacent to one another).
Regarding claim 7 the Wilson Hoo Combination teaches the assembly of claim 1 substantially as is claimed,
wherein Hoo further teaches the sleeve comprises a weakened portion longitudinally disposed in a wall of the sleeve (Figures 1-2 item 40).
Regarding claim 8 the Wilson Hoo Combination teaches the assembly of claim 7 substantially as is claimed,
wherein Hoo further discloses the weakened portion is configured to allow the expandable member to rupture a distal portion of the sleeve before an intermediate and proximal portion of the sleeve (the weakened portion 40 allows any longitudinal location of the sleeve to be ruptured by the expandable member; [0010]).
Regarding claim 9 the Wilson Hoo Combination teaches the assembly of claim 1 substantially as is claimed,
wherein Hoo further teaches the sleeve surrounds a length of the stent from a proximal end to a distal end of the stent (Figures 1-5 shows the sleeve 30 surrounding stent 20 along its entire length).
Claims 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson and Hoo as is applied above, further in view of Roberts et al. (US 5545209 A) hereinafter known as Roberts.
Regarding claim 3 the Wilson Hoo Combination teaches the assembly of claim 1 substantially as is claimed,
but is silent with regards to a distal portion of the expandable member being configured to radially expand before a proximal and intermediate portion.
However, regarding claim 3 Roberts teaches a delivery assembly for a stent (Figure 1 item 12) which has an expandable member (Figure 1 item 10) configured to have a distal portion radially expand before a proximal and intermediate portion (Column 9 lines 11-19). Wilson and Roberts are involved in the same field of endeavor, namely delivery assemblies. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the expandable member so it can allow a distal portion of the expandable member to expand before proximal and distal portions in order to allow part of the stent to be expanded and delivered before other parts of the stent, thus allowing for more easy repositioning if required and thus more accurate stent placement.
Regarding claim 4 the Wilson Hoo Combination teaches the assembly of claim 1 substantially as is claimed,
but is silent with regards to an inner sheath comprising a first lumen and a second lumen in fluid communication with the expandable member.
However, regarding claim 4 Roberts teaches a delivery assembly that includes an inner sheath comprising a first lumen extending therethrough (item 19; guidewire lumen) and a second lumen extending therethrough (item 21; inflation lumen) which is in fluid communication with the expandable member (Column 6 lines 47-51). Wilson and Roberts are involved in the same field of endeavor, namely delivery assemblies. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the assembly of the Wilson Hoo Combination so that there are two lumens as is taught by Roberts in order to allow for delivery over a guidewire in addition to having a lumen allowing for inflation of the balloon, thus ensuring the catheter assembly will actually work as is described by Hoo.
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson and Hoo as is applied above, further in view of McNiven et al. (US 20070006441 A1) hereinafter known as McNiven.
Regarding claim 5 the Wilson Hoo Combination teaches the assembly of claim 1 substantially as is claimed,
but is silent with regard to whether the stent is configured to imprint around a portion of the outer surface of the expandable member in the crimped state.
However, regarding claim 5 McNiven teaches a delivery assembly for a stent which teaches that a stent which is crimped around an expandable member is configured to imprint a portion of an outer surface of the expandable member ([0082]). Wilson and McNiven are involved in the same field of endeavor, namely delivery assemblies. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the assembly of the Wilson Hoo Combination so that the stent imprints when it crimps as is taught by McNiven in order to ensure the stent is securely crimped in place around the balloon.
Claims 10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson and Hoo as is applied above, further in view of Murray (US 20060111769 A1).
Regarding claim 10 Wilson discloses a method of deploying a self-expanding stent (Abstract) comprising:
positioning a distal portion (Figure 1 near item 44) of a stent deployment catheter assembly (Figure 1) adjacent a vascular target to be treated (Column 1 lines 9-14),
withdrawing an outer sheath of the assembly (Figure 8 item 40 ) relative to the stent to expose the stent (Figures 9-12 shows the sheath 40 as it withdraws from stent 50),
allowing the stent to self-expand to apply a radially outwardly directed force to the target (Figures 9-12; Column 1 lines 19-23), wherein a diameter of the target is expanded (Column 1 lines 22-23), and
but is silent with regards to partially expanding an expandable member of the assembly, to radially expand the stent, rupture a sleeve surrounding the stent, and smooth wrinkles from the stent.
However, regarding claim 10 Hoo teaches a method of deploying a self-expanding stent (Abstract) which includes positioning a distal portion of a stent deployment catheter assembly (Figures 4-5) adjacent a vascular target to be treated (see the target area in Figures 4-5), wherein the assembly includes an expandable member (Figures 4-5 item 90) which expands to radially expand the stent ([0017] the balloon 90 applies a force to the inner walls of the stent 20 to cause the stent to expand), and rupturing a sleeve (Figures 4-5 item 30; [0017]) that surrounds the stent (Figures 1-5). Wilson and Hoo are involved in the same field of endeavor, namely delivery of a stent. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Wilson to have the stent be expanded by a balloon and rupture a sleeve as is taught by Hoo in order to allow the device to be selectively positionable and deployable within the vasculature, allowing repositioning if desired, thus easing delivery and increasing accuracy of placement.
Further, regarding claim 10 Murray teaches expansion of a stent can smooth wrinkles therethrough ([0030]). Wilson and Murray are involved in the same field of endeavor, namely delivery of a stent. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Wilson Hoo Combination to have the stent have wrinkles smoothed during expansion as is taught by Murray in order to allow the prosthesis to maintain a patent lumen therethrough, and allow for optimal blood flow therethrough with minimal risk of tearing and ripping blood cells on wrinkles.
Regarding claim 15 the Wilson Hoo Murray Combination teaches the method of claim 10 substantially as is claimed,
wherein Hoo further teaches rupturing the sleeve comprises rupturing a weakened portion thereof ([0017]; Figures 4-5 item 40).
Claims 11-14, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson, Hoo, and Murray, further in view of Roberts as is applied above.
Regarding claim 11 the Wilson Hoo Murray Combination teaches the method of claim 10 substantially as is claimed,
but is silent with regards to partially expanding the stent comprises expanding a distal portion of the expandable member before a proximal or intermediate portion.
However, regarding claim 11 Roberts teaches a method of deploying a stent that includes expanding a distal portion of an expandable member before a proximal or an intermediate portion (Column 9 lines 11-19). Wilson and Roberts are involved in the same field of endeavor, namely methods of stent delivery. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Combination so that the distal end of the expandable member expands first as is taught by Roberts in order to allow the delivery of part of the stent before other parts, thus allowing the stent to be repositioned more easily if desired, and so resulting in an easier delivery and more accurate placement.
Regarding claim 12 the Wilson Hoo Murray Combination teaches the method of claim 10 substantially as is claimed,
but is silent with regards to partially expanding the stent comprises expanding a proximal portion of the expandable member before a distal or intermediate portion.
However, regarding claim 12 Roberts teaches a method of deploying a stent that includes expanding a proximal portion of an expandable member before a distal or an intermediate portion (Column 8 lines 21-23). Wilson and Roberts are involved in the same field of endeavor, namely methods of stent delivery. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Combination so that the distal end of the expandable member expands first as is taught by Roberts in order to allow the delivery of part of the stent before other parts, thus allowing the stent to be repositioned more easily if desired, and so resulting in an easier delivery and more accurate placement.
Regarding claim 13 the Wilson Hoo Murray Combination teaches the method of claim 10 substantially as is claimed,
but is silent with regards to partially expanding the stent comprises expanding an intermediate portion of the expandable member before a proximal or distal portion.
However, regarding claim 13 Roberts teaches a method of deploying a stent that includes expanding an intermediate portion of an expandable member before a distal or a proximal portion (Column 10 lines 50-51). Wilson and Roberts are involved in the same field of endeavor, namely methods of stent delivery. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Combination so that the distal end of the expandable member expands first as is taught by Roberts in order to allow the delivery of part of the stent before other parts, thus allowing the stent to be repositioned more easily if desired, and so resulting in an easier delivery and more accurate placement.
Regarding claim 14 the Wilson Hoo Murray Combination teaches the method of claim 10 substantially as is claimed,
but is silent with regards to partially expanding the stent comprises expanding a distal portion and proximal portion of the expandable member before an intermediate portion.
However, regarding claim 14 Roberts teaches a method of deploying a stent that includes expanding both a distal and proximal portion of an expandable member before an intermediate portion (Column 3 lines 34-42). Wilson and Roberts are involved in the same field of endeavor, namely methods of stent delivery. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Combination so that the distal end of the expandable member expands first as is taught by Roberts in order to allow the delivery of part of the stent before other parts, thus allowing the stent to be repositioned more easily if desired, and so resulting in an easier delivery and more accurate placement.
Regarding claim 16 the Wilson Hoo Murray Combination teaches the method of claim 15 substantially as is claimed,
but is silent with regards to rupturing a distal portion of the sleeve before rupturing an intermediate and proximal portion of the sleeve.
However, regarding claim 16 Roberts teaches a method of deploying a stent that includes expanding a distal portion of an expandable member before a proximal or an intermediate portion (Column 9 lines 11-19). Wilson and Roberts are involved in the same field of endeavor, namely methods of stent delivery. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Combination so that the distal end of the expandable member expands first as is taught by Roberts in order to allow the delivery of part of the stent before other parts, thus allowing the stent to be repositioned more easily if desired, and so resulting in an easier delivery and more accurate placement. This results in the Combination teaches rupturing the weakened portion of the sleeve (Hoo Figures 4-5 item 40) comprises rupturing a distal portion of the sleeve before rupturing an intermediate and proximal portion of the sleeve, since the expansion of the Combination requires the rupture of the sleeve 40 before expansion can occur, and the balloon of Hoo 90/Roberts 10 would rupture the sleeve at the weakened portion when allowing the distal portion before the other parts of the stent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
