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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The attempt to incorporate subject matter into this application by reference to an incorporation by reference statement added after an application’s filing is ineffective because no new matter can be added to an application after its filing date.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoo et al. (EP 1836998).
Hoo et al. discloses a method of deploying a self-expanding stent, comprising: positioning a distal portion of stent deployment catheter assembly adjacent a vascular target to be treated (see [0004] disclosing stent (20) positioning); withdrawing an outer sheath of the stent deployment catheter assembly relative to a self-expanding stent to expose the self-expanding stent (20) (see [0018] disclosing the retraction of the lumen (95) from its sheath (30)); partially expanding an expandable member of the stent deployment catheter assembly (see [0018] disclosing inflation of the balloon (90)); rupturing a sleeve surrounding the self-expanding stent (20) (see [0018] disclosing rupture of the fused film/sheath (30) inherently acting as a sleeve); allowing the self-expanding stent (20) to self-expand to apply a radial outward directed force to the vascular target, wherein a diameter of the vascular target is expanded (see [0007] disclosing the applying force to expand the diameter of the targeted vessel wall); expanding the expandable member (90) to radially expand the self-expanding stent and smooth wrinkles from the self-expanding stent (20) (see [0018] disclosing the stent is expanded to the desired degree, inherently smoothing out the wrinkles).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. (US 6425898) and further in view of Hoo et al. (EP 1836998).
Regarding claim(s) 1 and 7-9, Wilson et al. discloses a stent delivery catheter assembly, comprising: an outer sheath (40) (see Col. 6, lines 14-17 disclosing an outer sheath); an inner sheath (48) co-axially disposed within the outer sheath(40) (see Col. 4, lines 39-41; Col. 7, lines 50-52 disclosing an inner layer (48) and coaxial structure); but fails to disclose an expandable member surrounding a distal portion of the inner sheath; a self-expanding stent surrounding the expandable member; and a sleeve surrounding and selectively constraining the self-expanding stent, wherein the expandable member is configured to rupture the sleeve, allowing the self-expanding stent to radially self-expand; the sleeve comprises a weakened portion longitudinally disposed in a wall of the sleeve; the weakened portion is configured to allow the expandable member to rupture a distal portion of the sleeve before an intermediate portion and a proximal portion of the sleeve; and the sleeve surrounds a length of the self-expanding stent from a proximal end to a distal end of the self-expanding stent.
Hoo et al. also discloses an expandable balloon (90), a self-expanding stent (20) and an encasing sheath (30). Hoo et al. teaches an expandable balloon (90) attached distally to the catheter shaft (80) which includes a lumen (95) that is concentric with the shaft (80); the stent (20) positioned over the balloon (90); an encasing sheath (30) placed over the stent (20); and a compromised structural integrity (40) allowing the sheath (30) to rupture once the ballon is inflated (90) and allows the stent (20) to expand within the vessel (see Fig. 4; [0004], [0014] and [0018] disclosing the expandable member, self-expanding stent and the mechanism for the rupturable sleeve, and the proximal and the longitudinal structure with clearly defined proximal and distal extremities). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Wilson et al.’s coaxial delivery assembly, wherein a retractable sheath provides the balloon-actuated rupture mechanism for a self-expanding stent. Doing so would add improved deployment accuracy while incorporating an industry standard architecture of a coaxial inner/outer sheath.
Regarding claim 2, Wilson et al. in view of Hoo et al., discloses the stent delivery catheter assembly of claim 1, but fails to disclose a length of the expandable member is equal to or greater than a length of the self-expanding stent.
Hoo et al. also discloses a deployment mechanism with an inflatable balloon (90) offering structural alignment. Hoo et al. teaches the balloon (90) is attached to the shaft (80) and positioned within the stent (20) to rupture the sheath (30) across its length, thereby the balloon (90) must logically span the entire longitudinal dimension of the stent (20) (see Fig. 4 illustrating the longitudinal length of the ballon (90) with the stent (20)). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Wilson et al.’s coaxial delivery assembly, wherein a retractable sheath provides the balloon-actuated rupture mechanism for a self-expanding stent along its entire length for deployment accuracy. Doing so would ensure the complete and uniform deployment of the stent while maintaining the structural stability of the coaxial delivery system.
Regarding claim 4, Wilson et al. in view of Hoo et al., discloses the stent delivery catheter assembly of claim 1, but fails to disclose the inner sheath comprises: a first lumen extending therethrough; and a second lumen extending therethrough and in fluid communication with the expandable member.
Hoo et al. also discloses a catheter shaft (80) that structurally provides the framework for lumens. Hoo et al. teaches the shaft (80) is positioned within the delivery system, thereby making it the primary structure that would contain a first lumen extending through it for the purpose to receive a guidewire; an inherent second lumen to which the balloon (90) is attached distally to the catheter shaft (80) allowing inflation fluid to pass through its interior (see [0004] and [0018] disclosing the functional relationship with the inflation of the balloon (90) and the rupture of the film as a result of direct fluid communication within the balloon). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have Wilson et al.’s structure of a stent delivery catheter system, wherein a dual-lumen inner sheath created by a catheter shaft (80) allows for fluid communication the interior of the balloon (90) as taught by Hoo et al. Doing so would offer a design choice in having dual lumens in a catheter shaft (one for navigation over a guidewire and one for balloon inflation) to ensure functionality and ease during procedures.
Regarding claim 5, Wilson et al. in view of Hoo et al., discloses the stent delivery catheter assembly of claim 1, but fails to disclose the self-expanding stent is configured to imprint around a portion of an outer surface of the expandable member when the self-expanding stent is in a crimped state.
Hoo et al. also discloses a crimped state within the interior of the stent (20) (see [0017] disclosing the crimped state and encasing sheath (30)). Hoo et al. teaches the self-expanding stent (20) is surrounded by a film (30) and is mounted over the balloon (90), thereby creating a crimp (imprint) on the stent (20) as the ballon inflates (see [0017] disclosing the crimped state). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have Wilson et al.’s structure of a stent delivery catheter system, wherein force is sufficient enough to crimp the stent as taught by Hoo et al. Doing so would minimize the gap between the stent and the balloon to meet the low-profile requirements of a stent delivery system.
Regarding claim 6, Wilson et al. in view of Hoo et al., discloses the stent delivery catheter assembly of claim 5, but fails to disclose the expandable member is configured to limit longitudinal displacement of the self-expanding stent when the outer sheath is proximally withdrawn.
Hoo et al. also discloses a ballon (90) and a stent-in0sheath assembly. Hoo et al. teaches the ballon (90) is held in place with the stent (20) as the retraction of the lumen (95) retracts the sheath (30) (see [0018] disclosing the mechanical interaction of the balloon and the stent). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Wilson et al.’s structure of a stent delivery catheter system, wherein the retraction of a lumen limits the longitudinal displacement of the balloon (90) inside the stent (20) as taught by Hoo et al. Doing so would prevent the stent from jumping axially during deployment.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. (US 6425898) as applied to claim 1 above, in view of Hoo et al. (EP 1836998) and further in view of Klemm et al. (US 5458615).
Wilson et al. in view of Hoo et al., discloses the stent delivery catheter assembly of claim 1, but fails to disclose a distal portion of the expandable member is configured to radially expand before a proximal portion and an intermediate portion.
Klemm et al. also discloses a balloon (14) configured to provide sequential expansion from the distal end towards a proximal end (see Col. 5, lines 45-47; Col. 6, lines 5-9 disclosing the intravascular catheter and its components configured for sequential expansion). Klemm et al. teaches the expansion sequence (anchoring) during which the relative axial position adjustment at the distal end is exposed first, allowing the balloon (14) to radially expand before the proximal and intermediate portions (see Col. 5, lines 41-58 disclosing the sequential expansion steps). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the core structure for the delivery catheter assembly of Wilson et al., modified by Hoo et al., with the proven anchoring expansion sequence of a stent delivery system as taught by Klemm et al. Doing so would establish medical device components to achieve more accurate stent placement within a vessel wall.
Claim(s) 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hoo et al. (EP 1836998) as applied to claim 10 above, and further in view of Klemm et al. (US 5458615).
Hoo et al. in view of Klemm et al., discloses the method of claim 10, wherein rupturing the sleeve comprises rupturing a weakened portion (40) of the sleeve (see [0011] and [0017] disclosing the region of compromised structural integrity and the mechanism of rupture), but fails to disclose partially expanding the self-expanding stent comprises radially expanding a distal portion of the expandable member before radially expanding a proximal portion and an intermediate portion of the expandable member; partially expanding the self-expanding stent comprises radially expanding a proximal portion of the expandable member before radially expanding a distal portion and an intermediate portion of the expandable member; partially expanding the self-expanding stent comprises radially expanding a proximal portion of the expandable member before radially expanding a distal portion and an intermediate portion of the expandable member; partially expanding the self-expanding stent comprises radially expanding an intermediate portion of the expandable member before radially expanding a proximal portion and a distal portion of the expandable member; partially expanding the self-expanding stent comprises radially expanding a distal portion and a proximal portion of the expandable member before radially expanding an intermediate portion of the expandable member; and rupturing the weakened portion of the sleeve comprises rupturing a distal portion of the sleeve before rupturing an intermediate portion and a proximal portion of the sleeve.
Klemm et al. also discloses the structural configuration for sequential expansion (distal portion first) of an expandable stent (16). Klemm et al. teaches an elastic cone (58) having a small aperture (61) at its distal end and a large aperture (60) at its proximal end, is disengaged once the sheath (10) is withdrawn proximally and collapses in engagement about the distal portion of the catheter (12), inherently resulting in the distal portion of the balloon (14) radially expanding before the proximal and intermediate portions (see Col. 8, lines 34-42 disclosing the mechanical sequence of distal first and the radial force required for the targeted vessel wall; and Fig. 7 illustrating the position of the cone (58) after the relative axial movement of the sheath and catheter at the distal potion). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Hoo et al.’s sleeve-rupture mechanism, wherein a stent delivery system employs a specific sequential expansion architecture as taught by Klemm et al. Doing so would provide enhanced rupture-based release with the added longitudinal stabilization in the deployment of the stent.
Claim(s) 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. (US 6425898) and further in view of Hoo et al. (EP 1836998).
Wilson et al. in view of Hoo et al., discloses a prosthesis delivery catheter assembly, comprising: an outer sheath (40) (see Col. 5, lines 19-21 disclosing the outer sheath); an inner sheath co-axially disposed within the outer sheath (40) (see Col. 5, lines 19-21 disclosing an inner shaft (10), functioning similarly to an inner sheath, disposed within the outer sheath (40)) ; but fails to disclose an expandable pliant member surrounding a distal portion of the inner sheath, wherein the expandable pliant member is configured to engage a self-expanding prosthesis; the self- expanding prosthesis is configured to imprint around a portion of an outer surface of the expandable pliant member; a length of the expandable pliant member is equal to or less than a length of the self-expanding prosthesis; and the expandable pliant member limits longitudinal displacement of the self-expanding prosthesis.
Hoo et al. also discloses an expandable member balloon (90) and its engagement with a self-expanding prothesis. Hoo et al. teaches the balloon (90) is made of a pliant material (e.g., polymer) that surrounds the distal portion of the catheter shaft (80); a stent (20) that is crimped and mounted over the outer surface of the balloon (90) in order to engage the prosthesis to maintain its longitudinal position (see [0018] disclosing the configuration for engagement). Therefore, it would have been obvious to one having ordinary in the art before the effective filing date of the claimed invention to have provided Wilson et al.’s structural architecture of a delivery catheter assembly, wherein an expandable pliant balloon (90) is positioned at the distal portion in order to engage the prothesis as taught by Hoo et al. Doing so would provide a means to frictional stabilization while optimizing the delivery profile of the stent.
Conclusion
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/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799