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
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The disclosure is objected to because of the following informalities:
a. In paragraph [0007], line 1, “relate to a valve prosthesis include a prosthetic valve” should read “relate to a valve prosthesis including a prosthetic valve”
b. In paragraph [0008], line 1, “provides a valve prosthesis include a prosthetic valve” should read “provides a valve prosthesis including a prosthetic valve”
c. In paragraph [0009], line 1, “provides a valve prosthesis include a prosthetic valve” should read “provides a valve prosthesis including a prosthetic valve”
d. In paragraph [0009], line 9, “the stent structure with the tacking stitching” should read “the stent structure with the tacking stitches”
e. In paragraph [0009], line 10, “attached to stent structure” should read “attached to the stent structure”
Appropriate correction is required.
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(s) 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nir et al. (US 2021/0369452)
Regarding claim(s) 1 and 9, Nir et al. discloses a valve prosthesis comprising: a prosthetic valve (see [0085] disclosing a prosthetic cardiac valve (10)); a stent structure comprising suture slots (see [0016]; [0022] disclosing each strut has a plurality of recesses and the function of the recesses that function similar to slots); an outer skirt (see [0022] disclosing a skirt); and outer skirt sutures attaching the outer skirt to the stent structure, the outer skirt sutures being located within the suture slots (see [0013]; [0022] disclosing the skirt mounted to a frame, and the location of the sutures); and a stent structure comprising suture holes (see [0014] disclosing struts having passages, which act as holes along the length of the strut on the frame); and the outer skirt sutures being located within the suture holes (see [0015] disclosing holes in an optional attachment to the outmost surface of the frame which contains the skirt).
Regarding claim 2, Nir et al. discloses the valve prosthesis of Claim 1 wherein: the suture slots are on an inner surface of the stent structure (see [0013] disclosing the depressions and the suture placement on the frame; Figs. 25 and 26 illustrating passages and sutures positioned inward of the outer periphery).
Regarding claim(s) 3-4 and 10-12, Nir et al. discloses the valve prosthesis of Claim 2 wherein: the outer skirt sutures are recessed within the suture slots to be radially outward of the inner surface (see [0085] disclosing non-uniform struts (40) are recessed away from the inner surface of the catheter); wherein by recessing the outer skirt sutures within the suture slots, contact between the outer skirt sutures and the prosthetic valve is prevented (see [0072] disclosing the offset of sutures (17) can be flush or recessed to minimize contact between the sutures and the valve delivery system); wherein: the suture holes are radially outward of an inner surface of the stent structure (see [0014] disclosing the position of passages along the length of the struts); wherein: the outer skirt sutures are radially outward of the inner surface (see [0026] disclosing a suture knot configuration positioned on a radially inner surface of the strut, inherently allowing for the rest of the suture (parts with the holes) to remain radially outward relative to that innermost point (the knot)); and wherein: by locating the outer skirt sutures within the suture holes, contact between the outer skirt sutures and the prosthetic valve is prevented (see [0014]; [0015] disclosing passages being located inward of an outermost surface (e.g., skirt) of a periphery, thereby preventing the inner surface from touching the catheter).
Regarding claim(s) 5 and 13, Nir et al. discloses the valve prosthesis of claim 1 wherein: the stent structure comprises an inflow portion comprising a strut, the suture slots being formed within the strut (see [0012]; [0016] disclosing non-uniform struts that extend from a first end (inflow) to a second end (outflow), and each strut can have a plurality of recesses which function as slots along its width); and wherein the stent structure comprises an inflow portion comprising a strut, the suture holes being formed within the strut (see [0014] disclosing struts with passages along its length).
Regarding claim(s) 6-8 and 14-15, Nir et al. discloses the valve prosthesis of Claim 5 wherein: the strut has a length direction, a width direction, and a depth direction, the suture slots extending a depth in the depth direction less than a thickness of the strut in the depth direction (see [0016]; [0085] disclosing recesses which act as slots, extending into the width of strut; sutures recessed away from the inner diameter of the catheter, which supports the concept of slot depth being less than the total strut thickness, but greater than the suture thickness); wherein: the depth of the suture slots is greater than a thickness of the outer skirt sutures in the depth direction (see [0096] disclosing the diameter of the recessed portion being larger than the sutures in the recess); wherein: the suture slots extend across a width of the strut in the width direction (see [0016] disclosing the struts having a width); wherein: the strut has a length direction, a width direction, and a depth direction, the suture holes extending in the width direction through the strut (see [0101]; [0103] disclosing the struts (40) having a plurality of holes that are parallel to the outer surface of the frame, thereby extending in a width direction relative to the struts cross section); and wherein: the suture holes are larger than the outer skirt sutures (see [0087]; [0101] disclosing sutures (17) passing through holes (191) allowing for accurate and faster placement to accommodate the sutures, thereby requiring the hole size to be sufficient (larger) to allow the suture (17) to pass through and be retained).
Regarding claim 16, Nir et al. discloses a valve prosthesis comprising: a prosthetic valve comprising valve leaflets and a valve inflow cylinder proximal of the valve leaflets (see [0010]; [0011]; [0075] disclosing a prosthetic valve, a Sapien 3 valve design, which includes valve leaflets and an inflow portion); a stent structure comprising suture apertures extending radially through the stent structure (see [0014] disclosing struts having passages (apertures) along the length of the sutures, inherently in a radial direction to the axis of the stent); and tacking stitching tacking the prosthetic valve to the stent structure, the tacking stitching being located within the suture apertures (see [0021]; [0025]; [0116] disclosing sutures with a whip stich configuration along the length of the strut to tack the valve components to the frame).
Regarding claim(s) 17-18, Nir et al. discloses the valve prosthesis of Claim 16 wherein: the stent structure comprises a node having a suture aperture of the suture apertures therein (see [0013]; [0014] disclosing the stent structure with nodes and passages for the sutures to pass through); and wherein: the stent structure comprises a strut having a suture aperture of the suture apertures therein (see [0013]; [0051] disclosing a plurality of struts, and a hollow strut with a plurality of holes passing through the strut)).
Regarding claim 19, Nir et al. discloses the valve prosthesis of Claim 16 wherein the valve leaflets are defined by cusps, the tacking stitching being provided on the valve inflow cylinder adjacent and proximal to the cusps (see [0011]; [0081]; [0025]; [0116] disclosing the leaflets (60) are secured to form commissures (84) which create the functional cusp shape; and the Sapien valve design which is cylindrical in shape with an inflow and outflow end; and the whip stich configuration).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799