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.
Claim Objections
Claim 4 objected to because of the following informalities: “ahped” should read “shaped”. Appropriate correction is required.
Claim 9 objected to because of the following informalities: the phrase “surrounding the” is repeated. 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.
Claims 6 and 15 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.
Claim 6 and 15 recites the limitation "the guidewire". There is insufficient antecedent basis for this limitation in the claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 9-15, 19-21, 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forster (20070203561) in view of Alon (20210045874).
With regards to claim 1, Forster discloses a delivery system (100) to orient and deploy a prosthetic valve (30) at a native annulus comprising ([0002]): an elongate catheter (100) with a cavity portion (137, [0086]) and terminating in a distal nosecone (118, [0081]); an inner valve support (130) circumferentially disposed around the elongate catheter and located proximally to the distal nosecone ([0083]), wherein the inner valve support (130) is shaped to accommodate the most proximal portion of the prosthetic valve in a compressed configuration ([0088]); a capsule (110) containing the prosthetic valve in the compressed configuration ([0101]); a handheld body (102, 104, 106) containing a steering control (104) to orient the shape of the distal end of the elongate catheter and a deployment control to release the prosthetic valve ([0079]). Forester fails to disclose that the catheter has a flexible portion along the length thereof.
Alon, in the same field of art, discloses a catheter (100) terminating in a distal nosecone (122), and an inner valve support (114). Alon teaches that the catheter has a flexible portion along the length thereof ([0012]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Forster’s delivery system to include that the catheter has a flexible portion along the length thereof, as taught by Alon, in order to allow the catheter to be bent and controlled as it advances through vasculature ([0101]).
With regards to claim 2, Forster as modified by Alon teaches the delivery system of claim 1, and Forster further teaches further comprising the prosthetic valve (30) having a proximal portion shaped to be maintained in conforming engagement with the inner valve support (130) when the prosthetic valve is in the compressed configuration (FIG 1C, [0088]).
With regards to claim 3, Forster as modified by Alon discloses the delivery system of claim 1, and Forster further teaches wherein the inner valve support (130) is formed of a plurality of channels (114) that contain the proximal portion of the prosthetic valve ([0080]).
With regards to claim 4, Forster as modified by Alon discloses the delivery system of claim 3, and Forster further teaches wherein the channels (see annotated FIG 7) are shaped as a mirror image of the proximal portion of the prosthetic valve (channels in FIG 7 are convex, a mirror image of the concave proximal portion of the prosthetic valve).
With regards to claim 5, Forster as modified by Alon discloses the delivery system of claim 1, and Forster further teaches wherein the elongate catheter (100) is comprised of a guidewire (108) that terminates at a point proximal to the distal end of the nose cone (118) and within a body of the nosecone ([0102]).
With regards to claim 6, Forster as modified by Alon discloses the delivery system of claim 1, and Forster further teaches wherein the nose cone (118) has an annular proximal portion circumferentially surrounding the guidewire (108, FIG 17) and shaped to engage an inner portion of the most distal portion of the prosthetic valve (FIG 17).
With regards to claim 7, Forster as modified by Alon discloses the delivery system of claim 1, and Forster further teaches wherein the distal end of the elongate catheter has a tapered surface (118) between an outer diameter of the elongate catheter and in inner diameter of an interior space of the catheter containing the capsule (see annotated FIG 3A).
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With regards to claim 9, Forster as modified by Alon and Hake disclose the delivery system of claim 8, and Forster further teaches further comprising loading kit capsule supports (133, 132) surrounding the surrounding the distal end of the elongate catheter in a paired, annular fashion (FIG 3B) to establish a rigid region at the distal end of the elongate catheter ([0096]).
With regards to claim 10, Forster as modified by Alon discloses the delivery system of claim 1, but does not expressly teach wherein the flexible portion (Alon [0012]) of the elongate catheter (Alon 100) is comprised of a laser cut spine.
In an alternate embodiment, Alon further discloses a flexible portion of the elongate catheter (1206) is comprised of a laser cut spine ([0174], FIG 59). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Forster’s delivery system to include that the flexible portion of the elongate catheter is comprised of a laser cut spine, as taught by an alternate embodiment, in order to create bands and openings that varying the stiffness of the flexible portion ([0174]).
With regards to claim 11, Forster as modified by Alon disclose the delivery system of claim 1, and Forster further teaches wherein the flexible portion of the elongate catheter has a predetermined curvature ([0150]).
With regards to claim 12, Forster as modified by Alon discloses the delivery system of claim 1, and Forster further teaches that it has steering control (336), but fails to disclose wherein the steering control for the distal end of the elongate catheter is a flex knob that rotates in circumferential fashion around the handheld body.
Alon further discloses a pull wire for steering control of the catheter ([0150]). Alon teaches that the steering control for the distal end of the elongate catheter is a flex knob (478) that rotates in circumferential fashion around the handheld body ([0150]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Forster’s delivery system to include that the steering control for the distal end of the elongate catheter is a flex knob that rotates in circumferential fashion around the handheld body, as taught by Alon, as the modification merely involves a substitution of one known steering mechanism for another that obtains a predictable result of moving the distal end of a catheter.
With regards to claim 13, Forster as modified by Alon discloses the delivery system of claim 1, and Forster further teaches wherein the deployment control for the prosthetic valve is a deployment knob (150) that rotates in circumferential fashion around the handheld body ([0094]).
With regards to claim 14, Forster as modified by Alon discloses the delivery system of claim 1, but fails to disclose wherein the handheld body contains a pair of mounting rails oriented in substantially parallel continuation through the interior of the handheld body and operatively engaged with the steering control and the deployment control mechanisms.
Alon further discloses a handheld body (408) and teaches wherein the handheld body (408) contains a pair of mounting rails (424) oriented in substantially parallel continuation through the interior of the handheld body (FIG 41) and operatively engaged with the steering control and the deployment control mechanisms ([0145]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Forster’s delivery system to include that the handheld body contains a pair of mounting rails oriented in substantially parallel continuation through the interior of the handheld body and operatively engaged with the steering control and the deployment control mechanisms, as taught by Alon, in order to better allow for the longitudinal movement ([0145]).
With regards to claim 15, Forster as modified by Alon disclose the delivery system of claim 1, and Forster further teaches further comprising a stationary layer (112) that is traversed by the guidewire (108), the capsule (110), and is fixed in place relative to the exterior of the handheld body (102, 104, 106).
With regards to claim 19, Forster as modified by Alon discloses the delivery system of claim 1, and Forster further teaches wherein the elongate catheter (100) is further comprised of a rotatable capsule (110) having a rotational axis around the elongate catheter to selectively and rotatably position the prosthetic valve at the most distal end of the delivery system ([0110]).
With regards to claim 20, Forster as modified by Alon discloses the delivery system of claim 1, and Forster further teaches further comprising the prosthetic valve (30) having a frame portion (32) comprising a plurality of cells (44, 46, 48, 50, FIG 1) comprising interconnected struts (42) that are deformable for transition of a frame of the prosthetic valve from the collapsed to the expanded configuration ([0017]).
With regards to claim 21, Forster as modified by Alon discloses the delivery system of claim 20, and Forster further teaches wherein the frame (32) is comprised of commissure support positions (52) aligned at an intersection between adjacent valve leaflets (FIG 1A, [0016]).
With regards to claim 23, Forster as modified by Alon discloses the delivery system of claim 20, but fails to disclose wherein the frame has a downstream and comprising a halo located upstream to the commissure support positions.
Alon also discloses a frame (12) with commissure support positions (FIG 1, [0098]). Alon teaches that the frame (12) has a downstream (27) and comprising a halo located upstream to the commissure support positions (FIG 1, 26). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Forster’s delivery system to include wherein the frame has a downstream and comprising a halo located upstream to the commissure support positions, as taught by Alon, in order to better resist against axial dislodgement of the valve ([0093]).
With regards to claim 24, Forster as modified by Alon discloses the delivery system of claim 23, and Alon further teaches wherein the halo (FIG 1, 26) is shaped to be maintained in conforming engagement with the inner valve support when the prosthetic valve is in the compressed configuration (the shape of 26 is capable of being maintained in conforming engagement with the inner valve support when the prosthetic valve is in the compressed configuration).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forster (20070203561) in view of Alon (20210045874) as applied to claim 1 above, and further in view of Hake (20230030110).
With regards to claim 8, Forster as modified by Alon disclose the delivery system of claim 1, but fail to disclose it in combination with the prosthetic valve and a distal loading funnel having a cuff sized to accommodate the largest outer diameter of the prosthetic valve in an expanded condition.
Hake discloses an assembly to use with a prosthetic heart delivery device (200). Hake teaches a distal loading funnel (212) having a cuff (214) sized to accommodate the largest outer diameter of the prosthetic valve in an expanded condition ([0048]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Forster’s delivery system to include a distal loading funnel having a cuff sized to accommodate the largest outer diameter of the prosthetic valve in an expanded condition, as taught by Hake, in order to collapse the heart valve ([0048]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forster (20070203561) in view of Alon (20210045874) as applied to claim 1 above, and further in view of Le (20240024624).
With regards to claim 16, Forster as modified by Alon discloses the delivery system of claim 1, but fail to disclose that it is further comprising a locking ring fixedly attached to an interior of the handheld body.
Le discloses a delivery system (10) for a prosthetic valve (13), where the delivery system (10) has a handheld body (16). Le teaches that it is further comprising a locking ring (115) fixedly attached to an interior of the handheld body (FIG 6). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Forster’s delivery system to include that it is further comprising a locking ring fixedly attached to an interior of the handheld body, as taught by Le in order to couple press fit the components together ([0100]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable Forster (20070203561) in view of Alon (20210045874) as applied to claim 1 above, and further in view of Srinimukesh (20200345494).
With regards to claim 17, Forster as modified by Alon discloses the delivery system of claim number 1, but fails to disclose that it is further comprising a recapture mechanism deployable from the distal end of the elongate catheter and having an outer diameter greater than the outer diameter of the prosthetic valve.
Srinimukesh discloses a catheter (100) configured to deploy a prosthetic valve (70) at a native annulus ([0007]). Srinimukesh teaches a recapture mechanism (212) deployable from the distal end of the elongate catheter (FIG 8) and having an outer diameter greater than the outer diameter of the prosthetic valve (FIG 8, where tethers 212 surround prosthetic valve 70, and therefore has a greater diameter). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Forster’s delivery system to include that is further comprising a recapture mechanism deployable from the distal end of the elongate catheter and having an outer diameter greater than the outer diameter of the prosthetic valve, as taught by Srinimukesh, in order to optimize the position of the prosthesis ([0071]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forster (20070203561) in view of Alon (20210045874) as applied to claim 1 above, and further in view of Tabor (EP4378420A2).
With regards to claim 18, Forster as modified by Alon discloses the delivery system of claim 1, but fails to disclose that it is further comprising a deployable embolic protection mechanism surrounding the elongate catheter and having a diameter to closely engage with a sidewall of a native vessel to cause a substantial portion of blood flow to pass through the embolic protection mechanism when deployed during placement of the prosthetic valve at the native annulus.
Tabor discloses a delivery system (100) and a prosthetic valve (282). Tabor teaches that these include a deployable embolic protection mechanism (292) surrounding the elongate catheter and having a diameter to closely engage with a sidewall of a native vessel (292) to cause a substantial portion of blood flow to pass through the embolic protection mechanism when deployed during placement of the prosthetic valve at the native annulus (“The device 292 can be utilized during the implantation procedure to capture and trap any emboli released and/or generated by the valve procedure” [0049]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Forster’s delivery system to include a deployable embolic protection mechanism surrounding the elongate catheter and having a diameter to closely engage with a sidewall of a native vessel to cause a substantial portion of blood flow to pass through the embolic protection mechanism when deployed during placement of the prosthetic valve at the native annulus, as taught by Tabor, in order to entrap substances that may cause an thromembolic event and prevent stroke or further complications ([0047]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forster (20070203561) in view of Alon (20210045874) as applied to claim 21 above, and further in view of Spenser (6730118).
With regards to claim 22, Forster as modified by Alon discloses the delivery system of claim 21, but does not expressly teach wherein the valve leaflets are formed from a polymer.
Spenser, in the same field of art, discloses an implantable prosthetic valve (FIG 1), and teaches that the valve leaflets are formed from a polymer (col 3 line 4). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Forster’s delivery system to include that the valve leaflets are formed from a polymer, as taught by Spenser, as the modification merely involves a substitution of one known valve leaflet construction for another that obtains a predictable result of a biocompatible leaflet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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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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/R.F.N./Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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