DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
2. 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.
3. Claims 10 and 11 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.
a. Claim 10 recites the limitation "the undulating portion" in line 2. There is insufficient antecedent basis for this limitation in the claim.
b. Claim 11 recites the limitation "the undulating portion" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
4. 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.
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.
5. Claims 1-7 and 15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by NASR (US PG Pub No. 2018/0125650 A1; cited in Applicant’s IDS).
Regarding independent claim 1, NASR ‘650 discloses a prosthetic heart valve for replacing a native atrioventricular valve (Figure 11 and Figure 15; [0022], [0031], and [0064]), the prosthetic heart valve comprising:
a collapsible and expandable (Abstract; [0023], [0030], [0064]) frame (5), the frame including an atrial portion (10) including a circumferential row of cells (Figures 1, 5-7, 10, 11, and 14), a ventricular portion (15) including a circumferential row of cells (Figures 1, 5-7, 10, 11, and 14), and a center portion (7) extending between the atrial portion and the ventricular portion, the atrial portion and the ventricular portion flaring radially outwardly from the center portion in an expanded condition of the frame (Figure 11 and Figure 15; [0023], [0024], [0050]); and
a plurality of prosthetic leaflets (valve 40, comprising leaflets 45) mounted to the frame ([0031]);
wherein at least some of the struts forming the cells in the atrial portion include an undulating structure (Figure 11 – structures 9) positioned between two axially extending strut portions (see below for annotated Figure 11 of NASR ‘650), the undulating structure including at least one circumferentially extending strut portion (see below for annotated Figure 11 of NASR ‘650) and being configured to dampen forces transmitted across the undulating structure between the two axially extending strut portions ([0052]).
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Regarding claim 2, NASR ‘650 discloses wherein the frame includes a number of undulating structures (Figure 11 – several undulating structures 9) so that force applied to an inflow-most tip of any atrial cell in the atrial portion cannot transmit to an outflow-most tip of any ventricular cell without passing through at least one of the undulating structures ([0052]).
Regarding claim 3, NASR ‘650 discloses wherein each of the atrial cells intersects with a circumferentially adjacent atrial cell at a strut junction (70), and each of the strut junctions includes the undulating structure.
Regarding claim 4, NASR ‘650 discloses wherein each undulating structure includes a first curved portion (see below for annotated Figure 11 of NASR ‘650) extending from a first one of the two axially extending strut portions, and a second curved portion (see below for annotated Figure 11 of NASR ‘650) extending from a second one of the two axially extending strut portions.
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Regarding claim 5, NASR ‘650 discloses wherein the at least one circumferentially extending strut portion couples (directly or indirectly) the first curved portion to the second curved portion.
Regarding claim 6, NASR ‘650 discloses wherein the first curved portion extends in a first circumferential direction, and the second curved portion extends in a second circumferential direction opposite the first circumferential direction (see above for annotated Figure 11 of NASR ‘650, clearly showing the spatial orientation of both “curved portions”).
Regarding claim 7, as shown in Figure 11 of NASR ‘650, the two axially extending strut portions include a first inflow-side axially extending strut portion and a second outflow-side axially extending strut portion.
Regarding claim 15, NASR ‘650 discloses further comprising a sealing skirt positioned on an exterior surface of the frame (Figure 1 and Figure 15 and paragraph [0028]).
Claim Rejections - 35 USC § 103
6. 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.
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.
7. Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over NASR (US PG Pub No. 2018/0125650 A1; cited in Applicant’s IDS) in view of Murray (US PG Pub No. 2010/0256723 A1) and Wallace et al. (US PG Pub NO. 2018/0000580 A1).
Regarding claim 8, NASR ‘650 discloses the invention as claimed, except for particularly disclosing wherein the first inflow-side axially extending strut portion includes a first eyelet formed therein, and the second outflow-side axially extending strut portion includes a second eyelet formed therein. However, this is already known in the art. For example:
Murray ‘723 teaches (Figures 3 and 4) a prosthetic heart valve having struts comprising eyelets (316) sized to accommodate expansion restrictor device (suture, line, thread, or cord 320) in order to fix or hold the deployment diameter of stent structure at or slightly below the treatment site diameter to prevent the prosthetic valve from being over-sized upon initial deployment and/or from continued in-vivo expansion after deployment ([0024], [0027], [0029]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of axially extending strut portions as including eyelets formed therein, as taught by Murray ‘723, with the invention of NASR ‘650, in order to fix or hold the deployment diameter of stent structure, in combination with a suture member, at or slightly below the treatment site diameter to prevent the prosthetic valve from being over-sized upon initial deployment and/or from continued in-vivo expansion after deployment. A person of ordinary skill in the art at the time will be left with the choice of deciding the particular spatial position of the first and/or second eyelets, depending on, e.g., general frame/stent design; particular shape of the undulating structures; particular spatial orientation and/or position of the undulating structures; particular target/intended vessel; etc.
Wallace et al. ‘580 teaches (Figures 14, 15A, 15B, and 15D) a prosthetic heart valve comprising undulating structures (308) acting as a suspension to absorb forces placed on an anchoring member of the prosthetic heart valve to prevent or reduce forces on the strut frame ([0113]), wherein strut portions from the undulating structure comprise eyelets (Figures 15A, 15B, 15D) adapted to receive a suture member ([0084]) to prevent atrial anchor from flaring outwards during delivery ([0084]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of axially extending strut portions as including eyelets formed therein, as taught by Wallace et al. ‘580, with the invention of NASR ‘650, in order to prevent atrial anchor from flaring outwards during delivery. A person of ordinary skill in the art at the time will be left with the choice of deciding the particular spatial position of the first and/or second eyelets, depending on, e.g., general frame/stent design; particular shape of the undulating structures; particular spatial orientation and/or position of the undulating structures; particular target/intended vessel; etc.
Regarding claim 9, NASR ‘650 in view of Murray ‘723 and Wallace et al. ‘580 discloses further comprising a suture member (Murray ‘723 - [0024], [0027], [0029]; Wallace et al. ‘580 - [0084]) passing into the first eyelet and the second eyelet so that the suture member couples the first inflow-side axially extending strut portion to the second outflow-side axially extending strut portion.
Regarding claim 10, NASR ‘650 in view of Murray ‘723 and Wallace et al. ‘580 discloses wherein the suture member is configured to prevent the undulating portion from straightening upon application of a tensile force (Murray ‘723 - [0024], [0027], [0029]; Wallace et al. ‘580 - [0084]).
Regarding claim 11, NASR ‘650 in view of Murray ‘723 and Wallace et al. ‘580 discloses wherein the suture member is configured to allow the undulating portion to compress upon application of a compressive force (Murray ‘723 - [0024], [0027], [0029]; Wallace et al. ‘580 - [0084]).
8. Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over NASR (US PG Pub No. 2018/0125650 A1; cited in Applicant’s IDS) in view of Bregulla (US 8,920,488 B2).
Regarding claim 12, NASR ‘650 discloses the invention as claimed, except for particularly disclosing wherein each circumferentially extending strut portion has a length that is greater than a distance between circumferentially adjacent pairs of the first inflow-side axially extending strut portions. However, this is already known in the art. For example, Bregulla ‘488 teaches (Figure 2) a frame having undulating structures (14) comprising circumferentially extending strut portions (16) with a length that is greater than a distance between circumferentially adjacent pairs in order to provide the frame with greater ability to absorb torsional stresses (C3:L30-36; C6:L47-56). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein each circumferentially extending strut portion has a length that is greater than a distance between circumferentially adjacent pairs of the first inflow-side axially extending strut portions, as taught by Bregulla ‘488, with the invention of NASR ‘650, in order to provide the frame with greater ability to absorb torsional stresses.
Regarding claim 13, NASR ‘650 in view of Bregulla ‘488 teaches wherein each circumferentially extending strut portion is offset, in an axial direction, from circumferentially adjacent pairs of circumferentially extending strut portions (Bregulla ‘488 - Figure 2 and C6:L47-56).
Regarding claim 14, NASR ‘650 in view of Bregulla ‘488 do not particularly teach wherein each of the first inflow-side axially extending strut portions has an axial length that is different from the axial length of circumferentially adjacent pairs of the first inflow-side axially extending strut portions. Looking to Applicant’s specification, there is no criticality in the use of “wherein each of the first inflow-side axially extending strut portions has an axial length that is different from the axial length of circumferentially adjacent pairs of the first inflow-side axially extending strut portions”. At the time of the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have modified (e.g., vary the length of) the first inflow-side axially extending strut portions of NASR ‘650 in view of Bregulla ‘488 wherein each of the first inflow-side axially extending strut portions has an axial length that is different from the axial length of circumferentially adjacent pairs of the first inflow-side axially extending strut portions, because Applicant has not disclosed said particular feature provides an advantage, is used for a particular purpose, or solves a stated problem. A person of ordinary skill in the art would find useful to modify said length in order to distribute dampening in more than one direction. A change in size is generally recognized as being within the level of ordinary skill in the art.
9. Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over NASR (US PG Pub No. 2018/0125650 A1; cited in Applicant’s IDS) in view of Braido et al. (US PG Pub No. 2016/0354204 A1).
Regarding claim 16, NASR ‘650 discloses valve (40) as indirectly connected to tubular body (5) through fabric ([0032], [0033]). NASR ‘650 further discloses “valve 40 may be directly connected to outflow end 15 of tubular body 5 through one or more sutures 55. Additionally or alternatively, valve 40 may be directly connected to outflow end 15 of tubular body 5 with any suitable securing mechanism, such as, for example, an adhesive, clips, clamps, etc. In these embodiments, valve leaflets 45 may be directly connected to struts 12 such that valve leaflets 45 are connected to outflow end 15 of tubular body 5. Additionally, valve leaflets 45 may be directly connected to fabric 25 and/or fabric 25 may be directly connected to struts 12” ([0039). Therefore, NASR ‘650 discloses wherein the frame includes a plurality of commissure attachment “features” (e.g., fabric; an adhesive; clips; clamps; etc.), each of the prosthetic leaflets being coupled to the frame via the CAFs.
Further, this is already known in the art. For example, Braido et al. ‘204 teaches a prosthetic heart valve comprising:
a collapsible and expandable frame (stent 100, stent 400, stent 2100); and
a plurality of prosthetic leaflets mounted to the frame (Figures 32A-32C),
wherein at least some of the struts forming the cells in the atrial portion include an undulating structure (Figure 2 – undulating structure 104c; further, see Figure 21I and Figure 21J) positioned between two axially extending strut portions (104a, 104b), the undulating structure including at least one circumferentially extending strut portion (clearly shown in Figures 2, 21I, and 21J) and being configured to dampen forces transmitted across the undulating structure between the two axially extending strut portions ([0215]).
Braido et al. ‘204 further teaches wherein the frame includes a plurality of commissure attachment features (108, 708, 1511, 2108, 2720) in order to couple the prosthetic leaflets to the frame via the CAFs ([0099]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the frame includes a plurality of commissure attachment features, as taught by Braido et al. ‘204, with the invention of NASR ‘650 in order to couple the prosthetic leaflets to the frame via the CAFs.
Regarding claim 17, NASR ‘650 in view of Braido et al. ‘204 teaches wherein each CAF is an axially extending beam including a single column of eyelets (Figure 8A of Braido et al. ‘204 – lower half of CAF 708, which is an axially extending beam, clearly shows a single column of eyelets; Figure 12C of Braido et al. ‘204; Figure 28C of Braido et al. ‘204).
Regarding claim 18, NASR ‘650 in view of Braido et al. ‘204 teaches wherein each CAF includes a pair of circumferentially adjacent eyelets adjacent to each end of the single column of eyelets (Figure 8A of Braido et al. ‘204).
Regarding claim 19, NASR ‘650 in view of Braido et al. ‘204 teaches wherein each CAF is coupled to struts that extend to the center portion of the frame (Figures 7A-10F), so that in the expanded condition of the frame, the CAFs are generally axially aligned with the center portion of the frame and the center portion of the frame defines a minimum diameter of the frame.
10. Claim 20 is are rejected under 35 U.S.C. 103 as being unpatentable over NASR (US PG Pub No. 2018/0125650 A1; cited in Applicant’s IDS) in view of Gabby (US PG Pub No. 2003/0149477 A1; cited in Applicant’s IDS).
Regarding claim 20, NASR ‘650 discloses the invention as claimed, including the possibility of using tines on the center portion ([0027]), except for particularly disclosing wherein the frame includes a plurality of tines on the ventricular portion, each of the plurality of tines extending to a free end pointing toward the atrial portion in a collapsed condition of the frame. However, this is already known in the art. For example, Gabby ‘477 teaches (Figures 3-8) wherein the frame includes a plurality of tines (90, 92) on the ventricular portion, each of the plurality of tines extending to a free end pointing toward the atrial portion in a collapsed condition of the frame (Figures 9A, 9B; paragraph [0044]) in order to provide a clamping function on surrounding tissue when implanted ([0044]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the frame includes a plurality of tines on the ventricular portion, each of the plurality of tines extending to a free end pointing toward the atrial portion in a collapsed condition of the frame, as taught by Gabby ‘477, with the invention of NASR ‘650, in order to provide a clamping function on surrounding tissue when implanted.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774