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 .
Claim Objections
Claims 2, 3, 5 and 6 are objected to because of the following informalities:
Claim 2, lines 4-5: “the penetration direction” should recite “the radial direction”.
Claim 3 (line 1) and claim 4 (line 1): “the the” should recite “the”.
Claim 5, line 2: “innser shaft” should recite “inner shaft”.
Claim 6, line 1: “a stent delivery” should recite “a stent delivery device”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the inner sheath" in line 4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the inner sheath” is interpreted as “the inner shaft”.
Claim Rejections - 35 USC § 102
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.
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(s) 6 is rejected under 35 U.S.C. 102(a) (1) as being anticipated by Oka et al. (US 20120116413) [hereinafter Oka].
Regarding claim 6, Oka discloses a stent delivery 1 (Fig. 1A, para. 0045: “The tubular medical treatment instrument indwelling device 1 according to the first embodiment of this invention is a stent graft indwelling device for placing a radially expandable stent graft SG (tubular medical treatment instrument) at a diseased site”) comprising:
an inner shaft 30 comprising a distal-end tip 40 with a radial expansion shape of the inner shaft 3 (Fig. 1C, para 0045: “As shown in FIG. 1, it comprises a rod member 30 and a front tip 40…the front tip 40 is arranged in the forward or front end portion of the rod member 30”);
a thread H coupled to both a stent SG and the distal-end tip 40 (see Fig. 1C, para. 0081: “the engaging portion 42 of the front tip 40 is so constituted as a groove having a predetermined depth, that the engaging portion 42 having a relatively simple constitution can get stuck steadily with the hook H of the stent graft SG”); and
a tubular outer sheath 10 into which the inner shaft 30 is inserted (Figs. 1A-1B, para. 0050: “The sheath 10 in this invention is a tubular elongated member formed from a flexible material, and it is a member in which a rod main body 32 and the stent graft SG can be held inside its tubular body”),
wherein the distal-end tip 40 has a depression 42 for hooking the thread H (Figs. 1C, 2B, see quote from para. 0081 above), and the thread H is configured to be released from the depression 42 when the inner shaft 30 moves toward a proximal end of the tubular outer sheath 10 (para. 0045: “the rod member is constituted so as to be movable forward and backward inside the tubular sheath (in the lumen of the sheath 10) along the axial direction of the sheath 10 (in the longitudinal direction of the sheath 10)”; para. 0053: “Meanwhile, the stent graft SG is a device delivered to an indwelling site (diseased site) along through the inside of a blood vessel in a compressed state, with reduced diameter, and the rod member 30 is a member used to push and expose the stent graft SG in the above compressed state from the forward end of the sheath at the intended indwelling site”. Therefore, the thread is capable of being released from the depression when the inner shaft moves toward the proximal end of the tubular sheath 10 since the inner shaft is designed to move axially and the stent would be unconstrained from the sheath.).
Claim Rejections - 35 USC § 103
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.
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) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Goodson et al. (US 20100010617) [hereinafter Goodson] in view of Kinkade et al. (US 20130289703) [hereinafter Kinkade] and Bardsely et al. (US 20200229957) [hereinafter Bardsely].
Regarding claim 1, Goodson discloses a stent delivery device 100 (Fig. 1, para. 0001, 0022) comprising:
an inner shaft 106A, 130 (Fig. 1, para. 0038: “pull rod portion 130 extends along the length of longitudinal axis L of pushrod 106 and thus pull rod portion 130 is sometimes said to extend longitudinally or in the longitudinal direction.”), comprising a protrusion 502A at a distal-end side of the inner shaft 106A, 130 (see Fig. 5, para. 0058);
a tubular outer sheath 112 (para. 0023: “radially constraining stent-graft 108 within a sheath 112”) into which the inner sheath (interpreted as inner shaft 106A, 130) is inserted (see Fig. 1).
Goodson further discloses a stent 108 comprising a crown portion 118 that is coupled to the protrusion to attach the stent to the inner shaft for delivery (Fig. 5, para. 0057: “FIG. 5 is a partial side view of a stent-graft delivery system 100B having crown portion 118 of stent-graft 108 engaged with a stent-graft retainment system 110B”; para. 0061).
However. Goodson fails to disclose a thread coupled to both the stent and the protrusion.
Kinkade in the same field of endeavor of stent delivery devices teaches that it is known in the art to couple a stent 200 to protrusions 520 of an inner sheath 522 with thread 207 (Figs. 7-8, para. 0034: “Stent-graft prosthesis 200 also includes at least one radially-compressible stent or scaffold 206”; para. 0038: “Interior sections 230 of ring 207 transform or transition into temporary attachment loops 540 that longitudinally extend, i.e., extend in the direction of longitudinal axis L.sub.A of tubular graft 205 shown in FIG. 2, beyond first or proximal edge 202 of prosthesis 200 and engage or extend around prong or finger-like elements 520 of tip capture spindle 512”).
In light of this teaching, the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention (i.e., one skilled in the art would have recognized that the thread used in Kinkade would provide an alternative way to couple the stent to the delivery system during deployment (para. 0036: “Rather than using endmost crowns 208A of first end stent 206A to couple the prosthesis to a delivery system as in open-web or free-flow configurations, prosthesis 200 includes a ring 207 to couple the prosthesis to a delivery system during initial deployment”); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Modified Goodson further discloses wherein the protrusion 502A is retracted to release the thread and deploy the stent (see Figs. 6-7 of Goodson, para. 0065). However, modified Goodson fails to disclose wherein the protrusion is configured to be broken due to an external force applied to the thread.
Bardsley in the same field of endeavor of implant delivery devices teaches that it is known in the art for a protrusion 40 to include a breakable portion 490 such that the protrusion 40 is configured to be broken due to an external for applied to a thread 92 (Fig. 43, para. 0128: “The distal end of the engagement wire (40) is fixed to the internal ramp (492). The engagement loop (92) of the implant is preloaded so that it is captured by the engagement wire (40) prior to implant delivery. When releasing, the engagement wire (40) is pulled proximally, causing tension in engagement wire (40) until the breakable portion (490) is pulled apart, and thereby releasing the implant”).
The substitution of one known thread release mechanism (breakable protrusion as shown in Bardsely such that the protrusion comprises the breakable portion and the distal end is fixed within distal annular surface 506) for another (retractable protrusion as shown in modified Goodson) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the breakable protrusion shown in Bardsely would have yielded predictable results, namely, an alternative way to deploy the stent by way of applying a proximal force to the protrusion to thereby break and release the stent (para. 0128 of Bardsely).
Regarding claim 2, modified Goodson discloses wherein the inner shaft 106A, 130 comprises a through-hole 500 penetrating the inner shaft in a radial direction (Fig. 5, para. 0058 of Goodson: “pushrod 106A comprises at least one trench 500 extending partially or completely around the circumference of pushrod 106A”), the protrusion 502A is provided in the through-hole 500 so as to extend in a direction intersecting the penetration direction of the through-hole 500 (see Fig. 5 of Goodson which illustrates the protrusion extending axially, thereby intersection the through-hole which extends radially around the pushrod 106A).
Regarding claim 3, modified Goodson discloses wherein the thread is provided to be inserted through the through-hole (see Fig. 5 of Goodson which in combination with Kinkade would result in a product wherein the thread is inserted into the through-hole 500 of Goodson).
Regarding claim 4, modified Goodson discloses wherein the external force is generated when the inner shaft moves toward a proximal end of the tubular outer sheath (Figs. 2-3, para. 0047-0048 of Goodson disclose that proximal retraction of the inner shaft 106A, 130 occurs during retraction of the sheath; Fig. 43, para. 0128 of Bardsley teaches that proximal retraction of the inner shaft results in the breaking of the projection).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Goodson et al. (US 20100010617) [hereinafter Goodson] in view of Kinkade et al. (US 20130289703) [hereinafter Kinkade] and Bardsely et al. (US 20200229957) [hereinafter Bardsely], as applied to claim 1 above, and further in view of Chalekian et al. (US 20160220369) [hereinafter Chalekian].
Regarding claim 5, modified Goodson discloses all of the limitations set forth above in claim 1. However, modified Goodson fails to disclose wherein the inner shaft further comprises a distal-end tip with a radial expansion shape of the inner shaft.
Chalekian in the same field of endeavor of stent delivery devices 10 (para. 0004, 0038) teaches that it is known in the art for an inner shaft 26 to comprise a distal-end tip 14 with a radial expansion shape of the inner shaft 16 (Fig. 1A, para. 0039: “The inner shaft 26 may extend through the operating handle 20 and the catheter assembly 16 to the atraumatic tip 14 of the delivery device”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the inner shaft in modified Goodson to include the distal-end tip of Chalekian in order to provide the device with an atraumatic tip (para. 0038 of Chalekian) which is known in the art to allow safer insertion and prevent damage of surrounding tissue when the device is navigating to a target site.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Oka et al. (US 20120116413) [hereinafter Oka].
Regarding claim 7, Oka discloses all of the limitations required in claim 6. Oka further discloses wherein the distal-end tip 40 has a tapered surface tapered toward a distal end of the inner shaft 30 (see Fig annotated Fig. 1C below) and the depression 42 is adjacent to the tapered surface.
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Annotated Fig. 1C of Oka
However, Oka fails to disclose the depression provided in the tapered surface.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to relocate the depression to the tapered surface of the distal-end tip of Oka, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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