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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/8/2025 has been entered.
Response to Arguments
Applicant's arguments filed 10/8/2025 have been fully considered. Regarding the rejection of claim 1 under 35 U.S.C. 102(a)(2) as being anticipated by Shariari, applicant argues the inflow end of the arms 18 would need to be considered the terminal atrial end of the outer frame assembly since the arms appear to form the terminal atrial end of the prosthetic heart valve, but claim 1 requires the terminal atrial end of the outer frame assembly forms a continuous perimeter which is not true of the arms 18 of Shariari. This argument is not persuasive because Shariari further teaches a ring 244 in fig.9 that forms a continuous perimeter at the terminal atrial end of the outer frame assembly and the prosthetic heart valve.
Regarding the limitation “wherein the terminal atrium edge of the inner frame is positioned between the first portion of the annulus portion and the second portion of the annulus portion”, Applicant argues that although Shahriari describes the inner frame 28 may be shorter than the outer frame 26 in par.61, claim 1 is more specific and requires that the atrium edge of the inner frame is positioned between the first portion of the annulus portion and the second portion of the annulus portion which is not taught by an inner frame merely being shorter than the outer frame. With regard to a rejection of claim 1 under 102(a)(2), the examiner agrees that the somewhat broader teaching of where the atrium edge of the inner stent is located in Shahriari does not anticipate the claimed location. However, applicant’s specification does not disclose that the terminal atrium edge of the inner frame being positioned between the first portion and second portion of the annulus portion provides any advantage, is used for a particular purpose, or solves a stated problem. Also, the “first portion” and “second portion” are arbitrary as they can be defined near or somewhat far from an annulus minimum. Therefore, an inner frame 28 that is shorter than the outer frame 26 likely has a terminal atrium edge positioned between first and second portions of the annulus portion. Furthermore, it was known in the art before the effective filing date of the claimed invention to place a terminal atrium edge of an inner frame at the annulus as taught by an additional reference below. It would also have been obvious to position the terminal atrium edge of the inner frame of Shahriari at the annulus portion since the native leaflets extend from the annulus in a native heart valve and it is standard in the art of prosthetic devices to mimic native anatomy in prosthetic design.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 61/839237, 61/840313, and 14/155,535, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed applications do not disclose “a middle of the annulus portion has a smaller diameter than (i) a first portion of the annulus portion near the ventricle portion and (ii) a second portion of the annulus portion near the atrium portion”. Accordingly, claims 1-17 have an effective filing date of 6/25/2014 (the filing date of PCT/US2014/044047).
Specification
The disclosure is objected to because of the following informalities:
Par. 37 of the specification recites “The outer surface of the inner valve assembly 110, and/or the inner surface of the outer frame assembly 140” which is believed to be in error for --The outer surface of the inner valve assembly 140, and/or the inner surface of the outer frame assembly 110--.
Par.88 of the specification recites “halo 650” which is believed to be in error for --halo 655--.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 126 (at least par.27), 120, 130, 132 (at least par.24), 230 (at least par.40), 260 (at least par.41), 211, 254, 290 (at least par.43), 620, 630, 632 (at least par.81), 650, 660, 670 (at least par.82), 760 (at least par.90), 830, 832, 860, 880 (at least par.107).
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. 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 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.
Claims 1, 3, 6, 8, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Shahriari US 2016/0030169 (hereafter referred to as Shahriari) in view of Drasler et al. US 2015/0173898 (hereafter referred to as Drasler).
Regarding claim 1, Shahriari discloses a prosthetic heart valve 10 (fig.1) comprising an outer frame assembly 236 (fig.9) having an atrium portion (portion above the annulus) that extends to a terminal atrial end (considered at the ring 244 in fig.9), a ventricle portion (portion below the annulus portion) that extends to a terminal ventricular end (considered the bottom edge in figs.2 and 9), and an annulus portion between the atrium portion and the ventricle portion (portion between the dashed lines in annotated fig.9 below), the outer frame assembly including shape memory material such that the outer frame assembly reverts to a memory shape in the absence of applied forces (see nitinol in par.38 and self-expanding in par.36), and an inner valve assembly 38 including an inner frame 28 and prosthetic valve leaflets 24 attached to the inner frame, the prosthetic valve leaflets configured to allow blood to flow in a downstream direction (fig.2), the inner frame having an atrium end defining a terminal atrium edge (top edge of 28 in figs. 1-2) and a ventricle end (bottom end near 16 in fig.1), the inner valve assembly coupled to the outer frame assembly by a connection between the ventricle end of the inner frame and the ventricle portion of the outer frame assembly (par.36 discloses stitches, or other mechanical connectors, or adhesive at the ventricle end 16 of the device), the inner valve assembly and the outer frame assembly diverging from each other in an upstream direction away from the connection (fig.1 shows diverging at least at the ventricle portions), the annulus portion of the outer frame assembly being spaced radially from the inner valve assembly and radially inwardly deflectable towards the inner valve assembly to accommodate positioning of the annulus portion within a natural valve annulus having a perimeter smaller than a minimum perimeter of the annulus portion when the outer frame assembly has the memory shape (par.64 discloses the outer frame is oversized with respect to the native annulus and is deflectable inwards and discloses the inner frame may not engage the inner surface of the outer frame; fig.1 shows a gap between the inner and outer frames), wherein the annulus portion of the outer frame assembly is configured to be implanted within the natural valve annulus and to have a shape in which a middle of the annulus portion has a smaller diameter than (i) a first portion of the annulus portion near the ventricle portion and (ii) a second portion of the annulus portion near the atrium portion (see the annotated fig.9 below which shows the middle of the annulus portion having a smaller perimeter than the top and bottom portions of the annulus portion), wherein the first portion of the annulus portion is closer to the terminal ventricular end than the terminal atrial end, and the second portion of the annulus portion is closer to the terminal atrial end than the terminal ventricular end, and wherein the terminal atrial end of the outer frame assembly forms a terminal atrial end of the prosthetic heart valve, wherein the terminal atrial end of the outer frame assembly forms a continuous perimeter 244 (see annotated fig.9 below). Figs.1, 6, and 8 of Shahriari show the terminal atrium edge of the inner frame located above the second portion of the annulus portion, but Shahriari discloses the inner frame 28 may be shorter than the outer frame 26 in par.61. It seems that an inner frame that is shorter than the outer frame would have a terminal atrium edge between the first and second portions of the annulus portion, which can be defined somewhat arbitrarily in the middle region of the outer frame assembly. However, Shahriari does not specifically state that the terminal atrium edge of the inner frame is located between the first portion of the annulus portion and the second portion of the annulus portion.
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Drasler teaches a prosthetic heart valve, in the same field of endeavor, wherein a terminal atrium edge of an inner frame is positioned above (fig. 21F), below (fig. 21C), or at the waist 84 (figs. 21C, 21E, 21G) of an outer frame assembly annulus portion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the terminal atrium edge of the inner frame of Shahriari at the middle of the annulus portion, which is between the first and second annulus portions, since Drasler teaches the terminal atrium edge of an inner valve can be placed at this waist location and be suitable for use in the heart. Selection of the middle/waist as opposed to above or below the middle of the annulus would have been further obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention since Drasler teaches all three locations are suitable for the inner valve assembly terminal atrium edge therefore selection of the terminal atrium edge of the inner frame being positioned at the waist/between the first and second portions annulus portion would be an obvious matter of design choice. The examiner notes that applicant has not disclosed that that the terminal atrium edge of the inner frame being positioned between the first portion and second portion of the annulus portion provides any advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Shahriari’s prosthetic heart valve and applicant’s invention to perform equally well with either the terminal atrium edge positioned specifically between first and second annulus portions or the terminal atrium edge located below 26 but not necessarily between first and second annulus portions (this is disclosed by Shahriari par.61) since both locations have the inner valve assembly being shorter than the outer valve assembly. Therefore, it would have been prima facie obvious to modify Shahriari to obtain the invention of claim 1 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Shahriari especially in view of Drasler which specifically teaches the claimed location.
Regarding claim 3, see Shahriari par.59 for a non-porous cover 126 on the outer surface of the inner stent.
Regarding claim 6, the annulus portion has an hourglass shape as shown in fig.9 of Shahriari.
Regarding claim 8, see the annotated fig.9 of Shahriari above which shows the maximum perimeter of the ventricle portion being larger than a maximum perimeter of the annulus portion. Par.41 of Shahriari discloses that the caudal end 16, which is the minimum perimeter of the ventricle portion, may be greater than or smaller than the diameter at the cranial end 44 which is the minimum perimeter at the annulus portion. The outer frame assembly as shown in fig.9 is capable of having this shape when implanted within a natural valve annulus.
Regarding claim 10, see Shahriari par.59 for cylindrical and figs.1, 2, and 5.
Regarding claim 11, see Shahriari fig.9 which shows tapering portions and a larger atrium portion diameter than a ventricle portion diameter.
Regarding claim 12, see Shahriari fig.1 for an annular region between the inner and outer frames.
Claims 2, 4, 5, 7, 9, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Shahriari in view of Drasler as applied to claims 1 and 12 above, and further in view of Morriss et al. WO 2013/059747 (hereafter referred to as Morriss).
Regarding claims 2 and 7, Shahriari in view of Drasler discloses the prosthetic heart valve of claim 1 as discussed above, but Shahriari in view of Drasler does not disclose that each of the atrium portion and annulus portion of the outer frame assembly is D-shaped in cross-section.
Morriss teaches a prosthetic heart valve, in the same field of endeavor, wherein the outer frame 110 can be D-shaped (par.194) for the purpose of fitting a mitral valve which has a non-circular D-shape (par. 10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the atrium portion and annulus portion of the valve of Shahriari in view of Drasler in a D-shape as taught by Morriss in order to best fit a mitral valve (which is an atrioventricular valve) as is common in the art.
Regarding claims 4 and 5, as discussed above with respect to claim 3, Shahriari discloses a non-porous cover 126 on the outer surface of the inner stent. Shahriari further discloses the outer frame 26 may be covered (par.39). However, Shahriari in view of Drasler does not disclose that the outer frame assembly includes an outer frame and an inner covering disposed about an inner periphery of the outer frame and formed of a material substantially impermeable to blood, the covering of the inner frame coupled to the inner covering of the outer frame.
Morriss teaches a prosthetic heart valve, in the same field of endeavor, wherein an outer frame assembly includes an outer frame 110 and an inner covering 146 disposed about an inner periphery of the outer frame and formed of a material substantially impermeable to blood, a covering of an inner frame 120 coupled to the inner covering of the outer frame (figs.20C and 20E) for the purpose of providing a blood flow-inhibiting seal (pars. 219 and 221).
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 prosthetic heart valve of Shahriari in view of Drasler and add an inner covering disposed about an inner periphery of the outer frame formed of a material substantially impermeable to blood, the covering of the inner frame coupled to the inner covering of the outer frame as taught by Morriss in order to provide a better blood flow-inhibiting seal.
Regarding claim 9, Shahriari in view of Drasler discloses the prosthetic heart valve of claim 1 as discussed above, but Shahriari in view of Drasler does not disclose wherein the outer frame assembly has a stiffness in resistance to radial compression that varies in an axial direction of the outer frame assembly.
Morriss teaches a prosthetic heart valve, in the same field of endeavor, wherein a degree of flexibility can vary along the length of each longitudinal rib 114 (par.191). Morriss further teaches the inner frame and outer frame can be coupled by welding, therefore the resistance to radial compression at the connection is different from the resistance to radial compression at other axial locations (par.190).
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 frame assembly of Shahriari in view of Drasler to have longitudinal struts that vary in flexibility as taught by Morriss in order to tailor the flexibility of the prosthetic heart valve to a particular patient. It also would have been obvious to couple the inner and outer frames of Shahriari by welding as taught by Morriss since Morriss teaches this is a suitable coupling mechanism for securing inner and outer frames of a prosthetic heart valve. The prosthetic heart valve of Shahriari in view of Drasler as modified to have a welded connection as taught by Morriss comprises varying resistance to radial compression in an axial direction at least between the welded sections and sections away from the welded sections.
Regarding claim 13, Shahriari in view of Drasler discloses the prosthetic heart valve of claim 12 as discussed above, but Shahriari in view of Drasler does not disclose a pocket closure coupled between the outer frame assembly and the inner frame assembly and enclosing therewith a portion of the annular region.
Morriss teaches a prosthetic heart valve, in the same field of endeavor, wherein a pocket closure 359 is coupled between an inner surface of an outer frame assembly and an outer surface of an inner valve assembly and extending between the outer frame assembly and the inner valve assembly enclosing therewith a portion of annular region 163, forming a thrombus retaining pocket for the purpose of forming a region of clot for limiting the deflection of the ribs and making the device more rigid and securely anchored (par.230; 24C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a pocket closure as taught by Morriss to the prosthetic heart valve of Shahriari in view of Drasler in order to aid in securing the valve in position.
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Shahriari in view of Drasler in view of Morriss as applied to claim 13 above, and further in view of Delaloye et al. US 2014/0350668 (hereafter referred to as Delaloye). Shahriari in view of Drasler in view of Morriss discloses the prosthetic heart valve of claim 13 as discussed above. The pocket closure of Morriss forms a thrombus retaining pocket 163 as shown in fig.24C and the pocket closure is formed of fabric which is considered a woven material (par.230). While Shahriari in view of Drasler in view of Morriss discloses the invention substantially as claimed, Shahriari in view of Drasler in view of Morriss does not disclose that the pocket closure is formed of a material having a porosity that is sufficiently large to allow red blood cells to pass through the pocket closure into the thrombus retaining pocket and that is sufficiently small to prevent thrombus formed from the red blood cells to pass through the pocket closure from the pocket, wherein the pocket closure is formed at least in part of a material having a pore size less than 160 microns or between about 90 microns and 120 microns.
Delaloye teaches a heart valve prosthesis, in the same field of endeavor, wherein a sealing portion of the device which forms a pocket is formed of a material having a pore size of about 100 microns (see par.27 for about 0.1 mm) for the purpose of allowing communication of blood components therethrough and obstructing passage therethrough of blood emboli to prevent escape into the blood stream of any emboli that may form within the pocket (par.26).
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 pocket closure of Shahriari in view of Drasler in view of Morriss to have a porosity of 100 microns, which is less than 160 microns and between 90 microns and 120 microns, as taught by Delaloye in order to allow blood to pass through the material but prevent emboli from escaping into the blood stream.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Marchand et al. US 2016/0331529 discloses a prosthetic heart valve comprising an inner frame assembly and an outer frame assembly.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 6am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774