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 .
Status of Claims
Claims 1-20 are pending and examined below
Claim Objections
Regarding claims 14 and 15, Applicant is advised that should claim 15 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0117370A1 (Folan) in view of US 2023/0363932 (Korkuch)
Regarding claim 1, Folan discloses a medical stent, comprising:
an elongate tubular body (Fig. 6, tubular body 220) having an intermediate body region extending between a proximal end region and a distal end region (see Fig. 6);
the proximal end region defining a radially extending flange (Fig. 6, 228) that is adapted to secure the elongate tubular body relative to a first bodily structure (Fig. 6A, wherein 228 secures the stent relative to tissue wall 46);
the distal end region defining two or more elongate anchors (Fig. 6A, 230) which extend radially outwardly from the elongate tubular body (see Fig. 6A, in which 230 extend out radially), the two or more elongate anchors adapted to secure the elongate tubular body relative to a second bodily structure when in the deployment configuration (see Fig. 2 ,wherein 30 secures 20 relative to 40)
Folan discloses two or more elongate anchors that are in a deployment configuration (See Fig. 6A) but doesn't explicitly teach or disclose that they are movable from a delivery configuration to a deployment configuration.
Korkuch discloses two or more elongate anchors (Fig. 16A, 124) that are movable from a delivery configuration to a deployment configuration (¶0086, “movable between a delivery and a deployed configuration”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the two or more elongate anchors of Folan to be movable from a delivery configuration to a deployment configuration, as taught by Korkuch, in order to anchor without causing trauma to the vessel of a patient (¶0005)
Regarding claim 2, Folan further discloses wherein the distal end region comprises two or more elongate voids disposed between the two or more elongate anchors (See Fig. 6A, wherein elongate voids are present between the spacers 230)
Regarding claim 3, Folan discloses two or more elongate anchors that can be configured into a deployment configuration (see rejection of claim 1). Folan doesn't explicitly teach or disclose wherein the deployment configuration represents a remembered configuration for the two or more elongate anchors.
Korkuch discloses wherein the deployment configuration represents a remembered configuration for the two or more elongate anchors (¶0088, wherein movable between a delivery and deployed configuration corresponds to a remembered configuration for anchors 124)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the two or more elongate anchors of Folan to deploy as a remembered configured, as taught by Korkuch, in order to anchor without causing trauma to the vessel of a patient (¶0005).
Regarding claim 4, Folan discloses two or more elongate anchors (See rejection of claim 1). Folan doesn't explicitly teach or disclose that particulars of the constraints during delivery and deployment as claimed.
Korkuch discloses wherein each of the two or more elongate anchors (Fig. 16A, 124) are constrained during delivery to maintain the two or more elongate anchors in the delivery configuration (¶0089, wherien a compressed delivery position corresponds to constrained), and each of the two or more elongate anchors are adapted to move into the deployment configuration upon removal of the constraint (¶0086, wherein anchors 124 are configured between a delivery and deployment configuration)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to the anchors of Folan to be constrained during delivery and deploy once the constraint is removed, as taught by Korkuch, in order to address limb ischemia (¶0005).
Regarding claim 5, Folan doesn't explicitly teach or disclose wherein the two or more elongate anchors have a curved profile matching a curved profile of the intermediate body region of the elongate tubular body when in the delivery configuration.
Korkuch discloses wherein the two or more elongate anchors (Fig. 16b, 126) have a curved profile matching a curved profile of the intermediate body region of the elongate tubular body when in the delivery configuration (see Fig. 16B, wherein the anchors 126 match the profile of the intermediate member)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the anchors of Folan to have a curved profile that matches a curved profile of the intermediate body region when in a delivery configuration, as taught by Korkuch, in order to anchor without causing trauma to the vessel of a patient (¶0005)
Regarding claim 6, Folan doesn't explicitly teach or disclose wherein the two or more elongate anchors have a curved profile curving in an opposite direction from a curved profile of the intermediate body region of the elongate tubular body when in the delivery configuration
Korkuch discloses wherein the two or more elongate anchors (Fig. 16A, 126) have a curved profile curving in an opposite direction from a curved profile of the intermediate body region of the elongate tubular body when in the delivery configuration (see Fig. 16A and 16B, wherein anchors 126 curve in an opposite direction than the profile of the intermediate body)
Regarding claim 7, Folan further discloses two or more anchors (Fig. 6A, 230) wherein the two or more elongate anchors have a planar profile different from a curved profile of the intermediate body region of the elongate tubular body when in the delivery configuration (see Fig. 6A, wherein spacers 230 extend into a different plane and therefore have a different planar profile)
Regarding claim 8, Folan discloses an intermediate body which is braided ¶0045, “braided”) but doesn't explicitly teach or disclose wherein at least one of the two or more elongate anchors have a braid pattern different from that of the intermediate body region of the elongate tubular body.
Korkuch discloses wherein at least one of the two or more elongate anchors (Fig. 16A, 126) have a braid pattern different from that of the intermediate body region of the elongate tubular body (¶0006, wherein the first anchor may include a nitinol braid)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify at least one of the anchors of Folan with a different braid pattern than the intermediate body region, as taught by Korkuch, in order to allow it to move from a delivery configuration into a deployed configuration (¶0006).
Regarding claim 9, Folan further discloses comprising a polymeric covering (¶0058, “polymeric covering”) extending over the intermediate body region of the elongate tubular body (¶0065, stent 200 may include a covering, similar to covering 70 described above, see also ¶0058 wherein the covering fully covers the length of the stent)
Regarding claim 10, Folan further discloses wherein the polymeric covering extends over the at least two elongate anchors (¶0056, “entire stent and the spacers member may be covered by the covering”)
Regarding claim 11, Folan further discloses wherein the polymeric covering extends between the at least two elongate anchors (¶0056, “entire stent and the spacers member may be covered by the covering”)
Regarding claim 12, Folan further discloses a second radially extending flange distal of the radially extending flange within the proximal end region (Fig. 6A, wherein 226 corresponds to a second radially extending flange and is distal of 228)
Regarding claim 13, Folan further discloses wherein the elongate tubular body comprises a braided stent body (¶0065, wherein “braided or woven pattern” corresponds to a braided stent body of 200)
Regarding claim 14, Folan discloses a medical stent (Fig. 6A, 200), comprising:
an elongate tubular body (Fig. 6A, 220) having an intermediate body region extending between a proximal end region and a distal end region (see Fig. 6A); the proximal end region defining a proximal end anchor structure (Fig. 6A, wherein 228 corresponds a proximal end anchor structure)
Folan discloses two or more elongate anchors (Fig. 6A, 230) that are in a deployment configuration (See Fig. 6A) but doesn't explicitly teach or disclose that they are movable from a delivery configuration to a deployment configuration.
Korkuch discloses a medical stent comprising a distal end region (Fig. 16A) defining two or more anchors (Fig. 6A, two or more anchors 126) movable from a delivery configuration to a deployment configuration (¶0086) in which the two or more elongate anchors extend radially outwardly from the elongate tubular body (see Fig. 16A, wherein 126 extends radially outwardly)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the medical stent of Folan with two or more anchors moveable from a delivery configuration to a deployment configuration, as taught by Korkuch, in order to address limb ischemia (¶0005)
Regarding claims 15, Folan further discloses wherein the proximal end anchor structure comprises a radially extending flange (see Fig. 6A, wherein 228 corresponds to a radially extending flange)
Regarding claim 16, Folan further discloses wherein the proximal end anchor structure comprises a radially extending flange (see Fig. 6A, wherein 228 corresponds to a radially extending flange)
Regarding claim 17, Folan discloses an alternate embodiment (Fig. 7) wherein the proximal end anchor structure comprises an additional two or more elongate anchors in which the additional two or more elongate anchors extend radially outwardly from the elongate tubular body.
Folan doesn't explicitly teach or disclose that additional anchors are movable from a delivery configuration to a deployment configuration
Korkuch discloses anchors which are movable from a delivery configuration to a deployment configuration (¶0086, “movable between a delivery and deployed configuration”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the proximal two or more elongate anchors to be moveable from a delivery configuration to a deployment configuration, as taught by Korkuch, in order to address limb ischemia (¶0005).
Regarding claim 18, Forlan discloses a medical stent (Fig. 6A, 200), comprising:
an elongate tubular body (Fig. 6A, 220) having an intermediate body region extending between a proximal end region and a distal end region (see Fig. 6A);
the proximal end region defining a radially extending flange (Fig. 6A, 228);
the distal end region defining two or more anchors (Fig. 6A, 230) in which the two or more elongate anchors extend radially outwardly from the elongate tubular body (see Fig. 6A, wherein 230 extend outward radially); and
a polymeric covering extending over the intermediate body region (¶0065, stent 200 may include a covering, similar to covering 70 described above, see also ¶0058 wherein the covering fully covers the length of the stent)
Folan discloses two or more anchors (Fig. 6A, 230) that are in a deployed configuration (Fig. 6A) but doesn't explicitly teach or disclose that they are movable from a delivery configuration to a deployment configuration.
Korkuch discloses two or more elongate anchors (Fig. 16A, 124) that are movable from a delivery configuration to a deployment configuration (¶0086, “movable between a delivery and a deployed configuration”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the two or more elongate anchors of Folan to be movable from a delivery configuration to a deployment configuration, as taught by Korkuch, in order to anchor without causing trauma to the vessel of a patient (¶0005)
Regarding claim 19, Folan further discloses wherein the polymeric covering extends over the proximal end region (¶0065, stent 200 may include a covering, similar to covering 70 described above, see also ¶0058 wherein the covering fully covers the length of the stent)
Regarding claim 20, Folan further discloses wherein the polymeric covering extends over at least part of the distal end region (¶0065, stent 200 may include a covering, similar to covering 70 described above, see also ¶0058 wherein the covering fully covers the length of the stent)
Conclusion
Included below is relevant prior art that was considered but not relied upon for this office action:
US 2016/0317332 – discloses an atraumatic stent and a method for manufacturing
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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