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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 12-31 and 33 is/are pending. Claim(s) 22 and 33 is/are withdrawn. Claim(s) 1-11 and 32 is/are canceled.
Response to Arguments
Applicant’s arguments, filed 3/20/2026, with respect to the double patenting rejections have been fully considered and are persuasive. The double patenting rejections of claims 12-15, 16, 17-21, 23-26, 27, and 28-32 has/have been withdrawn due to the approval on 3/20/2026 of the terminal disclaimer filed on 3/20/2026.
Applicant’s arguments, filed 3/20/2026, with respect to the claim objection have been fully considered and are persuasive. The objections of claim 12 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 3/20/2026, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims has/have been withdrawn due to the Applicant’s amendments.
Applicant's arguments, with respect to the prior art, filed 3/20/2026 have been fully considered but they are not persuasive.
Applicant argues that because Rowe teaches the embodiment of Figures 4A-4F includes a device where the spacer ring is at/beyond the ends so that it can perform the function of covering sufficient surface area such that the replacement device can be held in place.
Examiner notes Row also teaches at [0048]: “As noted above, surgical valves, such as valve 60, typically vary widely in size and shape from patient to patient. Advantageously, the adapter stent 30 can be adapted to provide a suitable mounting platform for implanting a percutaneous replacement valve in a wide range of surgical valves varying in size and shape.”
Thus, as the device as modified in the prior art rejection performs the function of anchoring a replacement valve, the unmodified device is considered a preferred embodiment, but also not the only option. Lacking a teaching that contradicts Rowe’s [0048] disclosure, Applicant’s argument is not found persuasive.
Applicant appears to argue the amended element of a “generally cylindrical wall”. The Examiner notes the prior device could reasonably be generally cylindrical because the Rowe device is generally cylindrical (e.g. Figure 2) and is shown to be placed to fit within the prior device (e.g. Figures 4C-F) and would be placed within such a valve to fit without leakage to function properly. Further, “generally” cylindrical does not require perfectly cylindrical. Therefore, Applicant’s arguments are not persuasive.
The Examiner notes no arguments were made regarding the rejection of record’s modifications.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 12, 18-19, 23, and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe (US 2008/0208327 A1), alone.
Regarding Claim 12, Rowe teaches an assembly of a transcatheter heart valve secured within a bioprosthetic heart valve with leaflets (e.g. Figures 1 and 4A-G; transcatheter heart valve #12 and bioprosthetic heart valve with leaflets #60), the bioprosthetic heart valve having an inner space (e.g. Figures 4A-G; lumen into which the devices of Figure 1 are placed) and a generally cylindrical wall with an inside diameter (diameter of the lumen) and a central flow axis (inherently present, along the longitudinal axis of the bioprosthetic heart valve) defining an upstream direction and a downstream direction (e.g. Figure 4A, side closest ventricle #86 is upstream across the bioprosthetic heart valve and the side closest aorta #88 is downstream across the bioprosthetic heart valve), the bioprosthetic heart valve also having an annular cuff on an inflow side leading to the generally cylindrical wall that extends to the leaflets (e.g. Figure 4A, annular ring of #60 at the inflow end of the bioprosthetic heart valve), the assembly comprising:
a collapsible spacer ring (e.g. Figure 1, #30) having an inner shaft (lumen of #30) adapted to receive the transcatheter heart valve (e.g. Figure 1, #12 is placed within #30; see also Figures 4D-4E), the spacer ring defining a central flow axis (inherently present, along the longitudinal axis of the spacer ring) having an upstream direction and a downstream direction (e.g. Figures 1 and 4B, side closest ventricle #86 is upstream across the spacer ring and the side closest aorta #88 is downstream across the spacer ring), the downstream direction corresponding to a direction of blood flow from an upstream portion through a downstream portion of the bioprosthetic heart valve when the spacer ring is implanted within the bioprosthetic heart valve (blood inherently flows from the right ventricle #86 to the aorta #88, which is consistent with upstream and downstream for each the bioprosthetic heart valve and the spacer ring), the spacer ring having an expandable upstream spacer flange (e.g. Figure 1, upstream end flared portion), and the spacer ring inner shaft being sized to provide a cylindrical engagement surface for securing the transcatheter heart valve therein (e.g. Figure 2, [0026]; #12 is cylindrical and conforms to #30; thus, #30 is cylindrical),
wherein the spacer ring is collapsible to a reduced diameter smaller than an inner space of the bioprosthetic heart valve to enable advancement of the spacer ring into the inner space (e.g. [0026]), and wherein the spacer ring is expandable within the inner space with the upstream spacer flange (e.g. [0026]) configured to flip or rotate from a longitudinal orientation to a generally horizontal or radial position in contact with an upstream end of the inner space of the bioprosthetic heart valve (e.g. Figure 3 versus Figure 1, the flared ends of #30 as see in Figure 1 are flipped/rotated radially outward relative to the compressed configuration in Figure 3), and
an outside dimension of the upstream spacer flange is greater than the inside diameter of the generally cylindrical wall so that the upstream spacer flange abuts the annular cuff (e.g. Figures 4F-4G; annotated Figure 4F below shows the length of the flange, which is in the circled section; thus, the flange abuts the annular cuff), and
the downstream end of the spacer ring has external structure (e.g. [0035], attachment elements) to engage and anchor to the generally cylindrical wall (e.g. [0035]), the spacer ring inner shaft thus providing the cylindrical engagement surface (radially inner surface of #30) for expanding and securing the transcatheter heart valve therein (e.g. [0026]).
Rowe teaches the spacer ring is expandable as discussed supra and teaches a configuration, where if expanded a downstream end thereof is positioned upstream from the leaflets of the bioprosthetic heart valve (e.g. Figure 4B). However, the Examiner recognizes it is unlikely the spacer ring would be expanded at this location.
Thus, Rowe discloses the invention substantially as claimed but fails to teach the spacer ring is expandable and has a length sufficiently short such that a downstream end thereof is positioned within the generally cylindrical wall and upstream from the leaflets of the bioprosthetic heart valve (when at the final implantation site).
Rowe teaches the devices of Figure 1 may also be placed in prior valves other than that shown in Figures 4A-G (e.g. [0040], [0048]). Rowe teaches a spacer ring of shorter axial length than that in Figure 1 (e.g. Figures 7-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rowe such that the spacer ring is sized and placed in a prior heart valve such that when expanded at the final implantation site, the spacer ring is expandable and has a length sufficiently short such that a downstream end thereof is positioned within the generally cylindrical wall and upstream from the leaflets of the bioprosthetic heart valve as it is a simple substitution of one known element for another (here, differently sized spacer rings as taught by Rowe) to obtain predictable results (MPEP 2143(I)).
One of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that Rowe teaches using a spacer ring of the size needed for a given prior heart valve (e.g. [0040], [0048] and Figures 7-8 as discussed supra). Further, as Rowe teaches attachment means other than flared ends between the spacer ring and the prior heart valve, one of ordinary skill in the art before the effective filing date would also recognize that Rowe’s teachings include axial placement in a prior heart valve that is axially longer than the spacer ring when necessary.
Here, the spacer ring connects a prior implanted heart valve to a replacement transcatheter heart valve that is sized differently than that shown in Rowe’s embodiment of Figure 1. The substituted elements function is known and remains the same as that of the embodiment of Figure 1. When the prior heart valve’s position and size result in the spacer ring being located such that a downstream end thereof is positioned upstream from the leaflets of the bioprosthetic heart valve, the spacer ring remains anchored to the prior heart valve via the cited attachment means discussed supra, regardless of where the spacer ring’s downstream end is located relative to the prior heart valve.
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Annotated Figure 4F, Rowe
Regarding Claim 18, the spacer ring inner shaft is spring-loaded to provide an inward reaction force against the transcatheter heart valve (e.g. Rowe, [0032], the spacer ring is made of a shape memory material; when expanded beyond the remembered diameter, there is a reaction to the over expansion that is radially inward and toward the remembered size).
Regarding Claim 19, the spacer ring inner shaft is provided with a soft compressible docking inner surface selected from the group consisting of foam, a resilient polymer, a hydrogel, and a fabric covering (e.g. Rowe, Figure 1, [0032], #34).
Regarding Claim 23, Rowe teaches an assembly of a transcatheter heart valve secured within a bioprosthetic heart valve with leaflets (discussed supra for claim 12), the bioprosthetic heart valve having an inner space (discussed supra for claim 12) and a generally cylindrical wall with an inside diameter (discussed supra for claim 12) and a central flow axis (discussed supra for claim 12) defining an upstream direction and a downstream direction (discussed supra for claim 12), the bioprosthetic heart valve also having an annular cuff on an inflow side leading to the generally cylindrical wall that extends to the leaflets (discussed supra for claim 12), the assembly comprising:
a collapsible spacer ring (discussed supra for claim 12) having an inner shaft (discussed supra for claim 12) adapted to receive the transcatheter heart valve (discussed supra for claim 12), the spacer ring defining a central flow axis (discussed supra for claim 12) having an upstream direction and a downstream direction (discussed supra for claim 12), the downstream direction corresponding to a direction of blood flow from an upstream portion through a downstream portion of the bioprosthetic heart valve (discussed supra for claim 12) when the spacer ring is implanted within the bioprosthetic heart valve (e.g. Figures 4A-4G), the spacer ring having an expandable downstream spacer flange and an expandable upstream spacer flange (discussed supra for claim 12 and e.g. Figure 1, other flared end), wherein the upstream spacer flange has a radial dimension greater than the downstream spacer flange (discussed supra for claim 12), and the spacer ring inner shaft being sized to provide a cylindrical engagement surface for securing the transcatheter heart valve therein (discussed supra for claim 12),
wherein the spacer ring is collapsible to a reduced diameter smaller than the inner space of the bioprosthetic heart valve to enable advancement of the spacer ring into the inner space (discussed supra for claim 12), and wherein the spacer ring is expandable within the inner space and has a length sufficiently short such that the downstream spacer flange is positioned within and engages and anchors to the generally cylindrical wall upstream from the leaflets of the bioprosthetic heart valve (discussed supra for claim 12), wherein an outside dimension of the upstream spacer flange is greater than the inside diameter of the generally cylindrical wall so that the upstream spacer flange abuts the annular cuff (discussed supra for claim 12), the spacer ring inner shaft thus providing the cylindrical engagement surface for expanding and securing the transcatheter heart valve therein (discussed supra for claim 12).
Regarding Claim 29, the limitations of claim 29 are discussed supra for claim 18.
Regarding Claim 30, the limitations of claim 30 are discussed supra for claim 19.
Claims 13-16, 21, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe (US 2008/0208327 A1) as discussed supra and further in view of Chung, et al (Chung) (US 2014/0188221).
Regarding Claims 13 and 24, the spacer ring is made of a metal that is close in the galvanic series to a metal in the transcatheter heart valve (e.g. [0032], [0029], stainless steel and nitinol, respectively). Rowe teaches the previously implanted bioprosthetic cardiac structure being any know percutaneous valve (e.g. [0004]).
Rowe discloses the invention substantially as claimed but fails to teach the material of the previously implanted bioprosthetic cardiac structure.
Chung teaches a transcatheter heart valve (e.g. Figures 15, 15A-B, [0134]) comprising nitinol (e.g. [0132]).
Chung and Rowe are concerned with the same field of endeavor as the claimed invention, namely transcatheter heart valves having metal frames.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rowe such that the previously implant bioprosthetic cardiac structure is that as taught by Chung as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143). Here, Rowe teaches any prior implant is usable with the method of Rowe. Therefore, the predictable result is a method of adding an replacement implant into the implant of Chung.
The combination of Rowe and Chung teaches the spacer ring is made of a metal that is close in the galvanic series to both a metal in the transcatheter valve and a metal in the bioprosthetic cardiac structure (each metal of the three components are considered “close” in the galvanic series).
Regarding Claim 14, the inner space of the bioprosthetic heart valve is covered with a fabric (e.g. Chung, Figure 15A, #333, [0132]), and wherein the external structure anchors to the fabric (e.g. Chung, claim 16; as the fabric surrounds the frame of the prior heart valve, the fabric is at the radially inner surface at least at the ends of the support stent; thus the anchors of Rowe anchor into at least a portion of this fabric in the combined device).
Regarding Claim 15, the external structure comprises an expandable downstream spacer flange (e.g. Rowe, Figure 1).
Regarding Claim 21, the upstream spacer flange has a radial dimension greater than the downstream spacer flange (e.g. Rowe, annotated Figure 1 above; the radius to location 1 is larger than the radius to location 2).
Regarding Claim 16, the external structure comprises an array of anchors, barbs, or spikes (e.g. Rowe, [0035], there are at least two barbs, thus they form an array as broadly claimed).
Claims 17 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe (US 2008/0208327 A1) as discussed supra and further in view of Salahieh, et al (Salahieh) (US 2005/0137688 A1).
Regarding Claims 17 and 28, Rowe discloses the invention substantially as claimed but fails to teach there are snares coupled to the spacer ring for controlling expansion of the spacer ring.
Salahieh teaches snares (e.g. Figures 1A, 2A, #s 50) used to actuate anchors on the outer surface of the heart valve (e.g. [0079], [0080]).
Salahieh and Rowe are concerned with the same field of endeavor as the claimed invention, namely heart valves.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rowe to incorporate the snares coupled to the spacer ring for controlling expansion of the spacer ring as taught by Salahieh in order to control delivery of the spacer (e.g. Salahieh, [0079]), which would allow for finer positioning of different portions of the spacer ring.
Claims 20 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe (US 2008/0208327 A1) as discussed supra and further in view of Kassab (US 2010/0168836 A1) and further in view of Nunez, et al (Nunez) (US 2008/0033527 A1).
Regarding Claims 20 and 31, the spacer ring is at least partially balloon-expandable (e.g. Rowe, [0038]).
Rowe discloses the invention substantially as claimed but fails to teach the spacer ring has a pressure sensor built-in for limiting the outward pressure exerted by the balloon.
Kassab teaches delivery of a heart valve using a pressure sensor to limit the balloon pressure (e.g. [0030]), which is a method of limiting the outward pressure exerted by the balloon.
Rowe and Kassab are concerned with the same field of endeavor as the claimed invention, namely stented heart valves.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rowe such that the outward pressure exerted by the balloon is limited as taught by Kassab in order to size the implantation location (e.g. Kassab, [0030]).
The combination of Rowe and Kassab discloses the invention substantially as claimed but fails to teach the spacer ring has a pressure sensor built-in.
Nunez teaches a support frame having a built-in pressure sensor (e.g. [0067]).
Nunez and the combination of Rowe and Kassab are concerned with the same field of endeavor as the claimed invention, namely vascular support frames.
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 combination of Rowe and Kassab by incorporating the pressure sensor as taught by Nunez in order to the pressure at the heart valve (e.g. Nunez, [0067]).
Claims 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe (US 2008/0208327 A1) as discussed supra and further in view of Angell, et al (Angell) (US 4,035,849 A).
Regarding Claim 25, Rowe teaches the downstream spacer flange anchors to the fabric (e.g. [0035]).
Rowe discloses the invention substantially as claimed but fails to teach at least a part of the inner space of the bioprosthetic heart valve is covered with a fabric.
Angell teaches a wire frame of a heart valve enclosed in a fabric covering (e.g. Figure 9; column 6, lines 15-38).
Angell and Rowe are concerned with the same field of endeavor as the claimed invention, namely heart valves.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rowe such that the bioprosthetic valve has the fabric covering as taught by Angell as it is combining prior art elements according to known methods to yield predictable results (MPEP 2143(I)). Here, the results are predictable because each claimed element performs in the same manner in the combination as it does separately. Specifically, the bioprosthetic heart valve provided heart valve function and provides a support for placement of the replacement valve, while the covering provides attachment material.
Regarding Claim 26, the bioprosthetic heart valve has a stiffening band covered with the fabric (e.g. Angell, Figure 11, #45; column 6, lines 15-38).
Regarding Claim 27, the downstream spacer flange has an array of anchors, barbs, or spikes (e.g. Rowe, [0035], there are at least two barbs, thus they form an array as broadly claimed).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 4/20/2026
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