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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wing spreading skirt arranged on an outer side of the outflow channel” must be shown or the feature(s) canceled from the claim(s). The figures appear to all show the skirt interior to the stent and therefore interior to the outflow channel. Further, the figures do not show “an inflow channel side of the stent main body is also provided with a skirt”. The figures only show one skirt. Please clarify the claim language if the applicant means to claim that the skirt extends towards both the inflow and outflow channels. If only one skirt is being claimed, the claim antecedent basis should be adjusted to clarify this.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1, 3 is/are objected to because of the following informalities:
In regard to claim 1, the claim recites “a wing-spreading skirt” in line 2 of the claim. This should be “the wing-spreading skirt” since this element was already recited in the preamble. Further, it appears that “a skirt” in line 8 of the claim is the same skirt as “the wing spreading skirt” but possibly referring to the opposite end of the skirt. Consistent antecedent basis should be used throughout the claims for clarity.
In regard to claim 3, “pulling suture” should be “pulling sutures” for proper grammar in line 2 of the claim.
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.
Claim(s) 1-4, 6 is/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.
In regard to claim 1, “the surface” of the wing spreading skirt in line 7 of the claim and “the surface” of the stent main body in line 7 of the claim lack proper antecedent basis. “The other side” in lines 9-10 of the claim also lacks proper antecedent basis.
In regard to claim 2, the claim recites “the pulling suture connected in the wing-spreading skirt is integrally in a plurality of continuous shapes like a Chinese character "ji (L)"”. Accordingly, it is unclear if the Chinese character ji shape is being positively recited.
In regard to claim 3, the claim recites “the number of the pulling suture is 1, 2, 3, 4, 6, or 12, preferably 1”. Due to the use of “preferably one” it is unclear if the scope of the claim includes just one suture or any of the 1, 2, 3, 4, 5, or 12 sutures. It is recommended to remove the language “preferably 1”.
In regard to claim 4, the claim recites “the 2 or more pulling sutures described above”. It is unclear what “described above” refers to. This language does not refer to a specific claim and therefore it is unclear which description is being referred to.
In regard to claim 6, the claim recites “the pulling suture is made of a polymer material, preferably polyglycolic acid, polylactic acid, or poly(p-dioxanone).” Due to the use of the work preferably, it is unclear if the materials such as polyglycolic acid are being positively recited. It is recommended to remove the language “preferably”.
Claim 5 depends from claim 1 and are therefore also rejected under 112b.
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) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Krivoruchko (2020/0315790A1) in view of Zeng (CN109419572A) and in view of Melsheimer (2012/0165915A1).
In regard to claim 1, Krivoruchko teaches a balloon-expandable interventional valve stent (fig 1) with a foldable wing-spreading skirt 110, comprising
a stent main body 102, a valve leaflet 104 [0035: 104 includes one or more valve leaflets)
wherein the stent main body 102 comprises an inflow channel 144 positioned at a lower portion and an outflow channel 142 positioned at an upper portion (figure 1),
an inflow channel side 144 of the stent main body is also provided with a skirt 110 (it is not clear from the instant disclosure and figures if this is the same skirt as the wing spreading skirt; for examination purposes this has been interpreted as a second skirt).
However, while Krivoruchko teaches that the stent may be balloon expandable [0041], Krivoruchko does not teach the ends are firstly spread and the middle is subsequently spread. Further, Krivoruchko does not teach the arrangement of the pulling sutures as claimed or the use of two skirts.
Melsheimer teaches when a balloon is expanded and spread two ends of the stent main body are firstly spread, and the middle portion of the stent main body is subsequently spread (abstract: retract a sheath portion away from either end of the prosthesis or expansion prior to the middle of the prosthesis). This is a statement of intended use, patentable only based on the resulting structure of a self-expanding stent and delivery system which allows the ends to be deployed first.
It would have been obvious to one of ordinary skill in the art of vascular stents and delivery systems at the time the invention was filed to use the delivery system of Melsheimer in place of the delivery system of Krivorchko because this system is beneficial during emergency surgery [0007] because this technique reduces time [0005] and allows for repositioning. Since the stent of Krivorchko is self expanding, the stent is capable of being used with the sheath/balloon delivery system of Melsheimer in this manner.
Zeng teaches the wing-spreading skirt 2 is arranged on an outer side of the outflow channel (fig 3c; 2 is comprised of two skirts, both on the outer side of the stent and each toward an opposite stent end in as much as that of the instant invention), the side of the wing- spreading skirt 2 close to a middle portion of the stent main body is fixedly connected to the stent main body (figure 3c, affixed by 3 to stent main body 1), other portions (this could be any part) of the wing-spreading skirt 2 are not fixedly connected to the stent main body (figure 3c, the outer edge is not affixed to the stent but to the other skirt), and the surface of the wing-spreading skirt 2 is attached to the surface (interpreted as the outer surface) of the stent main body (Figure 3c attached to the stent body via 3; pg 9, p 16 of the translation: the apical margin of skirt 2 can be fixed by using suture as fixing belt 3 to stent 1);
a pulling suture 4 is connected to the wing-spreading skirt 2 (fig 3c, 4), one side of the pulling suture 4 is connected to the wing-spreading skirt 2 (see figures 3c, 4), the other side is connected to the skirt 2 on the inflow channel side (see fig 3c, connected to both skirts at opposite ends), and the pulling suture 4 is connected between the wing-spreading skirt (figure 3c) and the skirt (figure 3c) on the inflow channel side in a reciprocating manner for multiple times (see zig zag pattern in figures 3c-4; the suture is attached to both skirts which are towards opposite stent ends in figure 3c, in as much as that of the instant invention is)
when the stent main body 1 on the inflow channel side is spread, the skirt 2 on the inflow channel side is unfolded, and the pulling suture 4 connected to the skirt 2 on the inflow channel side is gradually tightened in a circumferential direction under the action of an expansion force of the balloon, (figure 3a collapsed; figure 3c unfolded; pg 5, p 13 of the translation; effect of force section is that skirt is axially moved)
such that the pulling suture 4 in the wing-spreading skirt 2 on an outflow channel side 142 is tensioned, and the tensioned pulling suture 2 causes the wing-spreading skirt to be folded in an axial direction of the stent main body to form a portion protruding outwards in a radial direction of the stent main body (figures 3a, 3c; folded and unfolded), thereby covering or occluding a paravalvular leak (see figure 12g).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the double skirt configuration and pulling suture pattern of Zeng in the invention of Krivoruchkou, in place of the suture pattern and the singular skirt of Krivoruchkou, because the double skirt will provide additional protection against paravalular leakage (abstract translation) and because the suture pattern provides more stable expansion (abstract of translation).
In regard to claim 2, Krivoruchko meets the claim limitations as discussed in the rejection of claim 1, but does not teach the pulling suture pattern as claimed.
Zeng further teaches the pulling suture 4 connected in the wing-spreading skirt 2 is integrally in a plurality of continuous shapes (this could be any shape) like a Chinese character "ji (L)" (this language is interpreted as best understood to not be positively reciting the shape of ji), (figure 3c, zig zag shape; figure 5, alternative shape; also shape contracted vs expanded in figures 3c, 3a)
and the pulling suture 4 is alternately arranged on an inner side and an outer side of the wing-spreading skirt for multiple times, such that the pulling suture on the inner side surface and the outer side surface of the wing-spreading skirt is in a dotted line shape (see stitched shape in figure 4; solid lines represent outside while dotted lines indicate inside);
when the pulling suture 4 is tensioned, the wing-spreading skirt 2 folded in the axial direction of the stent main body is in a multi-layer fold shape, and the wing-spreading skirt in the folded state is in a wing-spreading shape outwards in the radial direction of the stent main body under the combined action of the expansion force of the balloon and the tension force of the pulling suture. (see figure 3a, 3c; pg 4 of translation, p 16-18: folds; foldable structure) The structure is fully capable of being expanded with the assistance of a balloon as well (see expansion figures 3a, 3c.
In regard to claim 3, Krivoruchko meets the claim limitations as discussed in the rejection of claim 2, but does not teach the pulling sutures as claimed.
Zeng further teaches the number of the pulling suture is 1, 2, 3, 4, 6, or 12, preferably 1, and the pulling suture continuously passes through a plurality of connecting points in the wing-spreading skirt 2 and on the skirt of the inflow channel side 2. (See single suture in figures 3a, 3c)
In regard to claim 4, Krivoruchko meets the claim limitations as discussed in the rejection of claim 3, and further teaches there are 2 or more pulling sutures [0047: at least 4 pulling sutures] the 2 or more pulling sutures described above have equal length to each other (see for example pulling sutures 1120A-F in figure 11), are connected end to end in succession at the connecting points of the skirt on the inflow channel side, and jointly cover the whole circumference of the wing- spreading skirt (see figure 11).
Further, Zeng also further teaches the use of multiple pulling sutures (the force application part may be multiple, continuous, or at intervals) jointly covering the whole circumference of the wing-spreading skirt (pg 5, p 16: continuously distributed; claim 11: arrange multiple, circumferentially).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Krivoruchko (2020/0315790A1) in view of Zeng (CN109419572A) and in view of Hangzhou (CN109419572A) and further in view of Chandusko (8029529B1).
In regard to claims 5-6, Krivoruchko meets the claim limitation as discussed in the rejection of claim 4, and further teaches the wing-spreading skirt is made of a flexible non-metallic material. [0043: skirt is polyester, Dacron, PTFE]
However, Krivoruchko remains silent to the pulling suture material.
Chandusko teaches the pulling suture is made of a flexible non-metallic material; wherein the pulling suture is made of a polymer material, preferably polyglycolic acid, polylactic acid, or poly(p-dioxanone). (Col 6, lines 32-45: suture material could be synthetic polymers, polyglycolic acid, polylactic acid)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the suture material of Chandusko in place of the suture material of Krivorchko because these are functionally equivalent suture materials meant for use within the body and for expanding or collapsing a vascular device (abstract). MPEP 2144.06II
Conclusion
The applicant was called to clarify the drawing objection issues in order to facilitate compact prosecution on 4/6/2026 but no reply was received.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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