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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/8/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 1/8/26. The claims 26-28, 30-34, 36, 39-45, 47-50 are pending. The claims 26, 32, 33, and 42 are amended. Claims 49 and 50 are new.
Response to Arguments
Applicant’s arguments, filed 1/8/26 with respect to the rejections of claims 33, 34, 36, 39, 43-45 under 35 U.S.C. 103 as being unpatentable over Hariton (US2018/0250130) in view of Calisse (US2006/0155360). No arguments have been presented for the rejection and the amendments do not overcome the previous rejection. Therefore, the rejection has been maintained.
Applicant’s arguments, filed 1/8/26 with respect to the rejections of claims 26-28, 30-32, 47 and 48 under 35 U.S.C. 103 as being unpatentable over Hariton (US2018/0250130) in view of Dibie (US2018/0333259). Applicant argues, the amendment to recite “a proximalmost end of the outer stent is proximal of the proximalmost end of the inner stent such that no portion of the inner stent extends proximal of the proximalmost end of the outer stent” overcomes the previous rejection. Examiner disagrees, where the anchors 146 appear proximal to the tissue anchor 154. Furthermore, dependent on how the stent frame is oriented and implanted, each anchor 146 of the inner frame 30 can be deflected independently of adjacent anchor 146, [0099]. Therefore, the stent can be arranged so that the outer frame 60 at 137a would be proximal to a proximalmost end of the inner frame 30 at the anchor 146.
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 of this title, 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.
Claims 26-28, 30-32, 47, 48, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Hariton (US2018/0250130) in view of Dibie (US2018/0333259).
Regarding claim 26, Hariton discloses a stent (entire device, where a “stent” is interpreted as any generally tubular structure with a passage for blood flow) comprising:
an inner stent (inner frame 30, where the frame 30 is interpreted as a stent by being generally tubular and directing blood flow through it);
an outer stent (outer frame 60, where the frame 60 is interpreted as a stent by being generally tubular and directing blood flow through it), wherein the outer stent surrounds the inner stent to define an annular space between the outer stent and the inner stent (see Fig. 2A),
and a proximalmost end of the outer stent is proximal of the proximalmost end of the inner stent such that no portion of the inner stent extends proximal of the proximalmost end of the outer stent (see Fig. 7B, where all of frame 30 can be within frame 60, furthermore, dependent on how the frame 60 is oriented and implanted, since each anchor 146 can be deflected independently of adjacent anchor 146, [0099]; therefore, the stent can be arranged so that the outer frame 60 at 137a would be proximal to a proximalmost end of the inner frame 30 at the anchor 146);
a valve (20) connected to the inner stent ([0137]), wherein the valve has three valve leaflets ([0094], see Figs. 1A, 9B, the valve is shown with three leaflets); and
a plurality of connecting arms (arms of 52 that define the coupling points, see Fig. 3A) extending across the annular space (see Fig. 2A) and connecting an atrial end of the inner stent to the outer stent (see Fig. 2A),
wherein, in a collapsed, delivery configuration of the stent, and prior to implantation of the stent, each of the plurality of connecting arms extends in a direction from the atrial end of the inner stent towards a ventricular end of the outer stent and extends radially outward, from the atrial end of the inner stent (the connecting arms defined by arms and coupling points 52 extend radially outward in a collapsed configuration from the inner frame 30, see Fig. 2A for the collapsed configuration, the connecting arms extend in a direction from the atrial end of the inner stent toward a ventricular end of the outer stent by being rounded and extending in both directions, see annotated Fig. 3A).
Hariton does not explicitly disclose the outer stent has a radially-outward convex shape in an atrial area, a radially-outward concave shape at an annulus area, and a radially-outward convex shape at a ventricular area. Dibie teaches a replacement valve prosthesis having an outer stent with a curved section and the center of curve extending radially outward as shown at the atrial area 133 as shown in Fig. 1A and described in paragraph [0088] (this section is interpreted as the claimed outer stent having radially-outward convex shape in an atrial area). The outer stent further having a second curved section with both ends of the curve extending radially outward as shown at the annulus area 131 as shown in Fig. 1A and described in paragraph [0088] (this second section is interpreted as the claimed radially-outward concave shape at an annulus area). The outer stent further having a third curved section with center of curve extending radially outward as shown at the ventricular area 132 as shown in Fig. 1A and described in paragraph [0088] (this third section is interpreted as the claimed a radially-outward convex shape at a ventricular area).
It would have been obvious to one having ordinary skill in the art to have modified the shape of the outer stent of Hariton to include a radially-outward convex shape in an atrial area, a radially-outward concave shape at an annulus area, and a radially-outward convex shape at a ventricular area, as taught by Dibie, in order to provide a mechanical configuration with a convex shape and certain diameters to advantageously allow the three leaflets forming the native valve to be held in the open position without creating an obstacle, in the filling chamber of the right ventricle, to the flow of blood ([0088] of Dibie).
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Regarding claim 27, Hariton/Dibie makes obvious the stent of claim 26, Hariton further discloses the outer stent comprises 6 to 48 cells circumferentially (the outer frame 60 has 12 cells as shown in Fig. 1B, see [0075])
Regarding claim 28, Hariton further discloses wherein a connection connects each of the plurality of connecting arms to the inner stent (the arms of coupling points 52 are coupled to the inner stent 30, [0093]), yet is silent on the type of connecting means. Hariton teaches further teaches welding components to the frame 30 (see [0138]) (the limitation “connecting means” is being interpreted under 112(f) to be a “clip mechanism or type of screw… welding process or other useful techniques” according to the specification page 17, lines 10-14 of the instant specification, and equivalents thereof; [0138] of Hariton teaches welding for coupling components together). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have connected each of the plurality of connecting arms to the inner stent by a connecting means such as welding, as taught by Hariton, as doing so would have yielded predictable results, namely, provided a secure connection connecting each of the plurality of connecting arms to the inner stent as is desired by Hariton.
Regarding claim 30, Hariton/Dibie makes obvious the stent of claim 26, Hariton further discloses wherein the outer stent includes a plurality of loops (loops defined by cells of outer frame 60, see Fig. 1B) at an end of the outer stent, for loading the stent into a catheter (the loops are capable of assisting with loading the device into a catheter by having a portion that can be engaged).
Regarding claim 31, Hariton/Dibie makes obvious the stent of claim 26, Hariton further discloses wherein a proximalmost end of the inner stent is within the annulus area (proximalmost end of frame 30 is within the annulus area, see Fig. 4F of Hariton), and a distalmost end of the inner stent is in the ventricular area (distalmost end is within the ventricular area by the frame 30 being positioned down toward the left ventricle as shown in Fig. 4F of Hariton).
Regarding claim 32, Hariton/Dibie makes obvious the stent of claim 31, Hariton further discloses wherein a distalmost end of the outer stent (distalmost end of outer frame 60 includes a portion of strut 54 that extends down past the frame 30, see Fig. 7B, where all of frame 30 can be within frame 60, see Fig. 7B) is distal of the distalmost end of the inner stent (see Fig. 7B).
Regarding claim 47, Hariton/Dibie makes obvious the stent of claim 26, wherein the outer stent includes a groove (groove defined by where the struts 54 meet the ring frame, see Fig. 1B) at the annulus area of the outer stent. However, the modified invention does not explicitly disclose wherein a diameter of the outer stent at the groove is a smallest diameter of the outer stent. It would have been an obvious matter of design choice to one having ordinary skill in the art at the effective filing date of the application to have the diameter at the groove have the smallest diameter of the outer stent, because Applicant has not disclosed the groove having this diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the diameter of the groove of Hariton/Dibie and Applicant’s invention, to perform equally well with either the diameter of the groove of Hariton/Dibie or the claimed diameter of the groove because grooves would perform the same function of holding positioning the stent within the annulus of the heart valve.
Regarding claim 48, Hariton/Dibie makes obvious the stent of claim 26; yet, does not explicitly disclose wherein at least one of the connecting arms comprises a radial outward convex shape in the ventricular area. However, it would have been an obvious matter of design choice to one having ordinary skill in the art at the effective filing date of the application to have at least one of the connecting arms comprise a radial outward convex shape, because Applicant has not disclosed the connecting arms having the convex shape provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the connecting arms of Hariton and Applicant’s invention, to perform equally well with either the shape of Hariton or the claimed convex shape because both shapes would perform the same function of connecting the stent frame parts equally well.
Regarding claim 50, Hariton/Dibie makes obvious the stent of claim 26, wherein the connecting arms connect to the proximalmost end of the inner stent (the arms 52 that define coupling points are coupled to the inner stent 30, [0093], where the arms 52 are connected to the proximalmost end of the inner stent at least indirectly).
Claims 33, 34, 36, 39, 43-45 are rejected under 35 U.S.C. 103 as being unpatentable Hariton (US2018/0250130) in view of Calisse (US2006/0155360).
Regarding claim 33, Hariton discloses a stent (entire device, where a “stent” is interpreted as any generally tubular structure with a passage for blood flow) comprising:
an inner stent (inner frame 30, where the frame 30 is interpreted as a stent by being generally tubular and directing blood flow through it);
an outer stent (outer frame 60, where the frame 60 is interpreted as a stent by being generally tubular and directing blood flow through it), wherein the outer stent surrounds the inner stent to define an annular space between the outer stent and the inner stent (see Fig. 2A), and no portion of the inner stent extends proximally of an atrial end of the inner stent (atrial end of the inner stent interpreted as entirety of the half of the inner stent 30); and
a plurality of connecting arms (arms of 52 ) extending across the annular space from the atrial end (see Fig. 2A) of the inner stent toward a ventricular end (see Fig. 2E) of the outer stent (where the arms are defined as the arms and coupling points 52, and would extend between the space of the frames and the two ends of the frames as shown in Fig. 2D; when inner frame 30 is nested within outer frame 60), the plurality of connecting arms connecting the inner stent to the outer stent ([0093]),
wherein, in a collapsed, delivery configuration of the stent, and prior to implantation of the stent, each of the plurality of connecting arms extends radially outward from the inner stent (the connecting arms defined by arms and coupling points 52 extend radially outward in a collapsed configuration from the inner frame 30, see Fig. 2A for the collapsed configuration).
Hariton appears to show the outer stent having one cell longitudinally (see Fig. 1B); yet does not explicitly disclose the outer stent comprising 1 to 108 cells longitudinally. Calisse, in the same field of endeavor, teaches a stent having a single circumferential ring of unit cells ([0034], see Fig. 7) and teaches other embodiments with more rings of cells. Where Calisse teaches the number of unit cells longitudinally is a result effective variable, selected based on the desired flexibility of the stent ([0059]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the number of longitudinal cells within the claimed range, as it involves only adjusting the number of longitudinal cells disclosed by Calisse to require adjustment based on desired flexibility. Therefore, 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 outer stent to have 1 to 108 cells longitudinally as a matter of routine optimization since it has been held that “[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
Regarding claim 34, Hariton/Calisse makes obvious the stent of claim 33, Hariton further discloses wherein each of the plurality of connecting arms (52) connects to the inner stent at an atrial end of the inner stent (the struts with coupling points 52 are coupled to the inner stent 30, [0093], see annotated Fig. 3A, where the end is interpreted as the end of the stent including the coupling points 52).
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Regarding claim 36, Hariton/Calisse makes obvious the stent of claim 34, Haarer further discloses wherein a connection connects each of the plurality of connecting arms to the inner stent (the arms of with coupling points 52 are coupled to the inner stent 30, [0093]); yet is silent on the type of connecting means. Hariton teaches further teaches welding components to the frame 30 (see [0138]) (the limitation “connecting means” is being interpreted under 112(f) to be a “clip mechanism or type of screw… welding process or other useful techniques” according to the specification page 17, lines 10-14 of the instant specification, and equivalents thereof; [0138] of Hariton teaches welding for coupling components together). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have connected each of the plurality of connecting arms to the inner stent by a connecting means such as welding as taught by Hariton as doing so would have yielded predictable results, namely, provided a secure connection connecting each of the plurality of connecting arms to the inner stent as is desired by Hariton.
Regarding claim 39, Hariton/Calisse makes obvious the stent of claim 33, Hariton discloses wherein the outer stent includes a groove at an annulus area of the stent (groove defined at the bottom of anchors 54, see Figs. 2E, 6), between an atrial area of the stent and a ventricular area of the stent (see annotated Fig. 1B).
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Regarding claim 43, Hariton/Calisse makes obvious the stent of claim 33, Hariton further discloses wherein the outer stent includes a plurality of loops (loops defined by cells of outer frame 60, see Fig. 1B) at an end of the outer stent, for loading the stent into a catheter (the loops are capable of assisting with loading the device into a catheter by having a portion that can be engaged).
Regarding claim 44, Hariton/Calisse makes obvious the stent of claim 33, Hariton further discloses further comprising a valve (20) connected to the inner stent ([0137]), wherein the valve has three valve leaflets ([0094], see Figs. 1A, 9B, the valve is shown with three leaflets).
Regarding claim 45, Hariton/Calisse makes obvious the stent of claim 33, Hariton further discloses wherein the plurality of connecting arms are integral with the outer stent (the coupling elements are welded together and are therefore integral with the outer stent, [0138]).
Claims 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Hariton (US2018/0250130) in view of Calisse (US2006/0155360) as applied to claim 39 above, and further in view of Dibie (US2018/0333259).
Regarding claim 40, Hariton/Calisse makes obvious the stent of claim 39; yet, is silent regarding the outer stent has a radially-outward convex shape in the atrial area, a radially-outward concave shape at an annulus area, and a radially-outward convex shape at a ventricular area. Dibie teaches a replacement valve prosthesis having an outer stent with a curved section and the center of curve extending radially outward as shown at the atrial area 133 as shown in Fig. 1A and described in paragraph [0088] (this section is interpreted as the claimed outer stent having radially-outward convex shape in an atrial area). The outer stent further having a second curved section with both ends of the curve extending radially outward as shown at the annulus area 131 as shown in Fig. 1A and described in paragraph [0088] (this second section is interpreted as the claimed radially-outward concave shape at an annulus area). The outer stent further having a third curved section with center of curve extending radially outward as shown at the ventricular area 132 as shown in Fig. 1A and described in paragraph [0088] (this third section is interpreted as the claimed a radially-outward convex shape at a ventricular area).
It would have been obvious to one having ordinary skill in the art to have modified the shape of the outer stent of Hariton/Calisse to include a radially-outward convex shape in an atrial area, a radially-outward concave shape at an annulus area, and a radially-outward convex shape at a ventricular area as taught by Dibie in order to provide a mechanical configuration with a convex shape and certain diameters to advantageously allow the three leaflets forming the native valve to be held in the open position without creating an obstacle, in the filling chamber of the right ventricle, to the flow of blood ([0088] of Dibie).
Regarding claim 41, Hariton/Calisse/Dibie makes obvious the stent of claim 40, Hariton further discloses wherein a proximalmost end of the inner stent is within the annulus area (proximalmost end of inner frame 30 is within the annulus area, see Fig. 4F of Hariton), and a distalmost end of the inner stent is in the ventricular area (distalmost end is within the ventricular area by the inner frame 30 being positioned down toward the left ventricle as shown in Fig. 4F of Hariton).
Regarding claim 42, Hariton/Calisse/Dibie makes obvious the stent of claim 41, Hariton further discloses wherein a distalmost end of the outer stent is distal of the distalmost end of the inner stent (distalmost end of outer frame 60 includes a portion of strut 54 that extends down past the frame 30, see Fig. 7B, where all of frame 30 can be within frame 60, see Fig. 7B), and a proximalmost end of the outer stent is proximal of the proximalmost end of the inner stent (see Fig. 7B, where all of frame 30 can be within frame 60) such that no portion of the inner stent extends proximally of the atrial end of the inner stent (atrial end of the inner stent interpreted as entirety of the half of the inner stent 30).
Allowable Subject Matter
Claim 49 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
No prior art of record teaches or discloses “wherein in the collapsed, delivery configuration, the proximalmost end of the outer stent is proximal of the proximalmost end of the inner stent” in combination with the other limitations as recited in claim 26.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774