DETAILED ACTION
Claims 1-20 are pending in this application.
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 .
Claim Rejections - 35 USC § 102
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.
Claims 14 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chambers et al., hereinafter “Chambers” (U.S. Pub. No. 2018/0200049).
Regarding claim 14, Chambers discloses a method for preparing a prosthetic heart valve 300 for delivery into a patient by a delivery catheter 304 having a lumen (Figures 3A-3B, 5A-5B; [0051]-[0052], [0054]-[0055]), the prosthetic heart valve having a valve frame (Id.; valve is “stented”) defining an aperture (receiving valve portion 305 within stent) that extends along a central axis and a flow control component 305 mounted within the aperture (Id.), the method comprising:
transitioning the prosthetic heart valve 300 from an expanded configuration to a compressed configuration ([0052]; valve is collapsed before loading within catheter 304) by:
compressing the valve frame laterally along a lateral axis of the valve frame that is perpendicular to the central axis such that a lateral width of the valve frame is less than a lumen diameter (Figures 3A-3B, 5A-5B, [0048]-[0049], [0052]; since the valve in the expanded configuration has an oversized frame along a lateral axis of the valve frame perpendicular to the central axis to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis, the valve frame is compressed as claimed in order to be loaded into the catheter), and
compressing the valve frame vertically along the central axis such that a height of the valve frame is less than the lumen diameter (Id.; since the valve in the expanded configuration has an oversized frame vertically along the central axis of the valve frame to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the central axis, the valve frame is compressed as claimed in order to be loaded into the catheter); and
inserting the prosthetic heart valve 300 in the compressed configuration into the lumen of the delivery catheter such that a longitudinal axis of the valve frame is substantially parallel to a lengthwise cylindrical axis of the lumen of the delivery catheter (Figures 3A-3B, 5A-5B, [0052], [0054], [0055]; since the valve is delivered in a sideways orientation), the longitudinal axis of the valve frame being perpendicular to each of the central axis and the lateral axis (Id.).
Regarding claim 18, Chambers discloses the lateral width and the height of the prosthetic heart valve in the compressed configuration are a first lateral width and a first height (as in Figure 3A; the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis and the central axis, so the valve frame is compressed as claimed to a first lateral width and a first height in order to be loaded into the catheter), respectively, the prosthetic heart valve in the expanded configuration having a second lateral width along the lateral axis that is greater than the lumen diameter and a second height along the central axis that is greater than the lumen diameter (as in Figure 3B; the valve in the expanded configuration has an oversized frame along the lateral axis and the central axis of the valve frame, so the valve frame has a second lateral width and a second height to allow expansion anchoring within a heart chamber).
Claim Rejections - 35 USC § 103
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Chambers (U.S. Pub. No. 2018/0200049) in view of Alkhatib (U.S. Pub. No. 2010/0249911).
Regarding claim 15, Chambers discloses the claimed invention, as discussed above, except for the valve frame forms a plurality of wire cells having an orientation and cell geometry configured to minimize strain associated with the valve frame being compressed along the central axis.
In the same field of art, namely prosthetic heart valves for delivery, Alkhatib teaches in Figure 7, [0060], [0063] a valve frame forming a plurality of wire (strut) cells 222, 224, 226 having an orientation and cell geometry configured to minimize strain associated with the valve frame being compressed along a central axis (the cells close along their length, or along a central axis, wherein a particular design for the cells reduces strain during collapsing/compressing; Id.)
It would have been obvious to one of ordinary skill before the effective filing date to modify the valve frame of Chambers to form a plurality of wire cells as claimed, as taught by Alkhatib, in order to reduce strain during compressing which reduces the likelihood that the wire cells get deformed or damaged.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chambers (U.S. Pub. No. 2018/0200049) in view of Forster et al., hereinafter “Forster” (U.S. Pub. No. 2005/0203614).
Regarding claim 16, Chambers discloses the claimed invention, as discussed above, except for the valve frame includes two panels, the compressing the valve frame laterally includes folding the valve frame laterally so that the two panels are approximately parallel.
Forster teaches in Figures 3D-3E and [0145] a valve frame including two panels 36c and 36a or 36b, and compressing the valve frame laterally includes folding the valve frame laterally so that the two panels are approximately parallel (when nested).
It would have been obvious to one of ordinary skill before the effective filing date to modify the valve frame of Chambers with two panels as claimed, as taught by Forster, in order to facilitate transitioning between compressed and expanded configurations, and to compress the valve frame in a low, nested profile facilitating advancement through the body of a patient.
Regarding claim 17, Chambers discloses the claimed invention, as discussed above, except for the compressing the valve frame laterally includes folding the valve frame along a distal fold area of the valve frame and along a proximal fold area of the valve frame.
Forster teaches in Figures 3D-3E and [0145] compressing a valve frame includes folding the valve along a distal fold area (near one of hinges 58) of the valve frame and along a proximal fold area (near opposite hinge 58) of the valve frame.
It would have been obvious to one of ordinary skill before the effective filing date to modify the valve frame of Chambers with folding the valve frame along a distal fold area of the valve frame and along a proximal fold area of the valve frame as taught by Forster, in order to facilitate transitioning between compressed and expanded configurations, and facilitate compressing the valve frame in a low, nested profile for advancement through the body of a patient.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chambers (U.S. Pub. No. 2018/0200049) in view of Kovalsky et al., hereinafter “Kovalsky” (U.S. Pub. No. 2014/0222142).
Regarding claims 19-20, Chambers discloses the claimed invention, as discussed above, except for the valve frame has a tension arm that extends laterally from a distal subannular portion of the valve frame, the inserting the prosthetic heart valve in a compressed configuration into the lumen of the delivery catheter is such that the tension arm is disposed toward a distal end or distal to the central axis of the valve frame.
Kovalsky teaches in Figure 9, [0111] a prosthetic heart valve frame including a tension arm 806A or 806B ([0216]; the arms are made of shape memory wire material and therefore may apply tension or pressure to tissue when expanded) that extends laterally from a distal subannular portion (depending on the orientation and positioning, for instance if to the right of the page in Figure 9 is the distal direction, then the tension arm 806B would extend from a distal subannular portion) of the valve frame (it is noted that “subannular” can be considered as below the top annular portion 802 of the frame, and not necessarily being seated below an annulus of a native heart valve).
It would have been obvious to one of ordinary skill before the effective filing date to modify Chambers with a tension arm as claimed, as taught by Kovalsky, in order to facilitate engaging tissue around the native valve (Id.). It is noted that when combined with the delivery catheter of Chambers, the tension arm 806A or 806B will be disposed toward a distal end or distal to the central axis of the valve frame.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14, 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 14 of U.S. Patent No. 10,321,995 in view of Chambers (U.S. Pub. No. 2018/0200049). Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 14 of U.S. Patent No. 10,321,995 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Alkhatib (U.S. Pub. No. 2010/0249911). Claims 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 14 of U.S. Patent No. 10,321,995 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Forster (U.S. Pub. No. 2005/0203614). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that subject matter recited in the application claims are encompassed by the patent claims, except for features that are merely obvious.
Chambers teaches compressing a flow control component 305 and a valve frame (valve 300 is “stented”) laterally along a lateral axis of the valve frame that is perpendicular to a central axis such that a lateral width of the valve frame is less than a lumen diameter of catheter 304 (Figures 3A-3B, 5A-5B, [0048]-[0049], [0052]; since the valve 300 in the expanded configuration has an oversized frame along a lateral axis of the valve frame perpendicular to the central axis to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis, the valve frame is compressed as claimed in order to be loaded into the catheter), and compressing the valve frame vertically along the central axis such that a height of the valve frame is less than the lumen diameter (Id.; since the valve in the expanded configuration has an oversized frame vertically along the central axis of the valve frame to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the central axis, the valve frame is compressed as claimed in order to be loaded into the catheter). Chambers teaches the lateral width and the height of the prosthetic heart valve in the compressed configuration are a first lateral width and a first height (as in Figure 3A; the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis and the central axis, so the valve frame is compressed as claimed to a first lateral width and a first height in order to be loaded into the catheter), respectively, the prosthetic heart valve in the expanded configuration having a second lateral width along the lateral axis that is greater than the lumen diameter and a second height along the central axis that is greater than the lumen diameter (as in Figure 3B; the valve in the expanded configuration has an oversized frame along the lateral axis and the central axis of the valve frame, so the valve frame has a second lateral width and a second height to allow expansion anchoring within a heart chamber).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with the above features, as taught by Chambers, in order to lower the profile of the heart valve during advancement to facilitate deploying the valve.
In the same field of art, namely prosthetic heart valves for delivery, Alkhatib teaches in Figure 7, [0060], [0063] a valve frame forming a plurality of wire (strut) cells 222, 224, 226 having an orientation and cell geometry configured to minimize strain associated with the valve frame being compressed along a central axis (the cells close along their length, or along a central axis, wherein a particular design for the cells reduces strain during collapsing/compressing; Id.)
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with a plurality of wire cells as claimed, as taught by Alkhatib, in order to reduce strain during compressing which reduces the likelihood that the wire cells deform or get damaged.
Forster teaches in Figures 3D-3E and [0145] a valve frame including two panels 36c and 36a or 36b, and compressing the valve frame laterally includes folding the valve frame laterally so that the two panels are approximately parallel (when nested) and compressing a valve frame includes folding the valve along a distal fold area (near one of hinges 58) of the valve frame and along a proximal fold area (near opposite hinge 58) of the valve frame.
It would have been obvious to one of ordinary skill before the effective filing date to modify the valve frame of Chambers with two panels and folding the valve frame along a distal fold area of the valve frame and along a proximal fold area of the valve frame as taught by Forster, in order to facilitate transitioning between compressed and expanded configurations, and facilitate compressing the valve frame in a low, nested profile for advancement through the body of a patient.
Claims 1-14, 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 11,273,033 in view of Chambers (U.S. Pub. No. 2018/0200049). Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 11,273,033 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Alkhatib (U.S. Pub. No. 2010/0249911). Claims 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 11,273,033 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Forster (U.S. Pub. No. 2005/0203614). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that subject matter recited in the application claims are encompassed by the patent claims, except for features that are merely obvious.
Chambers teaches compressing a flow control component 305 and a valve frame (valve 300 is “stented”) laterally along a lateral axis of the valve frame that is perpendicular to a central axis such that a lateral width of the valve frame is less than a lumen diameter of catheter 304 (Figures 3A-3B, 5A-5B, [0048]-[0049], [0052]; since the valve 300 in the expanded configuration has an oversized frame along a lateral axis of the valve frame perpendicular to the central axis to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis, the valve frame is compressed as claimed in order to be loaded into the catheter), and compressing the valve frame vertically along the central axis such that a height of the valve frame is less than the lumen diameter (Id.; since the valve in the expanded configuration has an oversized frame vertically along the central axis of the valve frame to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the central axis, the valve frame is compressed as claimed in order to be loaded into the catheter). Chambers teaches the lateral width and the height of the prosthetic heart valve in the compressed configuration are a first lateral width and a first height (as in Figure 3A; the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis and the central axis, so the valve frame is compressed as claimed to a first lateral width and a first height in order to be loaded into the catheter), respectively, the prosthetic heart valve in the expanded configuration having a second lateral width along the lateral axis that is greater than the lumen diameter and a second height along the central axis that is greater than the lumen diameter (as in Figure 3B; the valve in the expanded configuration has an oversized frame along the lateral axis and the central axis of the valve frame, so the valve frame has a second lateral width and a second height to allow expansion anchoring within a heart chamber).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claim with the above features, as taught by Chambers, in order to lower the profile of the heart valve during advancement to facilitate deploying the valve.
In the same field of art, namely prosthetic heart valves for delivery, Alkhatib teaches in Figure 7, [0060], [0063] a valve frame forming a plurality of wire (strut) cells 222, 224, 226 having an orientation and cell geometry configured to minimize strain associated with the valve frame being compressed along a central axis (the cells close along their length, or along a central axis, wherein a particular design for the cells reduces strain during collapsing/compressing; Id.)
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claim with a plurality of wire cells as claimed, as taught by Alkhatib, in order to reduce strain during compressing which reduces the likelihood that the wire cells deform or get damaged.
Forster teaches in Figures 3D-3E and [0145] a valve frame including two panels 36c and 36a or 36b, and compressing the valve frame laterally includes folding the valve frame laterally so that the two panels are approximately parallel (when nested) and compressing a valve frame includes folding the valve along a distal fold area (near one of hinges 58) of the valve frame and along a proximal fold area (near opposite hinge 58) of the valve frame.
It would have been obvious to one of ordinary skill before the effective filing date to modify the valve frame of Chambers with two panels and folding the valve frame along a distal fold area of the valve frame and along a proximal fold area of the valve frame as taught by Forster, in order to facilitate transitioning between compressed and expanded configurations, and facilitate compressing the valve frame in a low, nested profile for advancement through the body of a patient.
Claims 1-14, 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,278,437 in view of Chambers (U.S. Pub. No. 2018/0200049). Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,278,437 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Alkhatib (U.S. Pub. No. 2010/0249911). Claims 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,278,437 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Forster (U.S. Pub. No. 2005/0203614). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that subject matter recited in the application claims are encompassed by the patent claims, except for features that are merely obvious.
Chambers teaches compressing a flow control component 305 and a valve frame (valve 300 is “stented”) laterally along a lateral axis of the valve frame that is perpendicular to a central axis such that a lateral width of the valve frame is less than a lumen diameter of catheter 304 (Figures 3A-3B, 5A-5B, [0048]-[0049], [0052]; since the valve 300 in the expanded configuration has an oversized frame along a lateral axis of the valve frame perpendicular to the central axis to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis, the valve frame is compressed as claimed in order to be loaded into the catheter), and compressing the valve frame vertically along the central axis such that a height of the valve frame is less than the lumen diameter (Id.; since the valve in the expanded configuration has an oversized frame vertically along the central axis of the valve frame to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the central axis, the valve frame is compressed as claimed in order to be loaded into the catheter). Chambers teaches the lateral width and the height of the prosthetic heart valve in the compressed configuration are a first lateral width and a first height (as in Figure 3A; the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis and the central axis, so the valve frame is compressed as claimed to a first lateral width and a first height in order to be loaded into the catheter), respectively, the prosthetic heart valve in the expanded configuration having a second lateral width along the lateral axis that is greater than the lumen diameter and a second height along the central axis that is greater than the lumen diameter (as in Figure 3B; the valve in the expanded configuration has an oversized frame along the lateral axis and the central axis of the valve frame, so the valve frame has a second lateral width and a second height to allow expansion anchoring within a heart chamber).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claim with the above features, as taught by Chambers, in order to lower the profile of the heart valve during advancement to facilitate deploying the valve.
In the same field of art, namely prosthetic heart valves for delivery, Alkhatib teaches in Figure 7, [0060], [0063] a valve frame forming a plurality of wire (strut) cells 222, 224, 226 having an orientation and cell geometry configured to minimize strain associated with the valve frame being compressed along a central axis (the cells close along their length, or along a central axis, wherein a particular design for the cells reduces strain during collapsing/compressing; Id.)
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claim with a plurality of wire cells as claimed, as taught by Alkhatib, in order to reduce strain during compressing which reduces the likelihood that the wire cells deform or get damaged.
Forster teaches in Figures 3D-3E and [0145] a valve frame including two panels 36c and 36a or 36b, and compressing the valve frame laterally includes folding the valve frame laterally so that the two panels are approximately parallel (when nested) and compressing a valve frame includes folding the valve along a distal fold area (near one of hinges 58) of the valve frame and along a proximal fold area (near opposite hinge 58) of the valve frame.
It would have been obvious to one of ordinary skill before the effective filing date to modify the valve frame of Chambers with two panels and folding the valve frame along a distal fold area of the valve frame and along a proximal fold area of the valve frame as taught by Forster, in order to facilitate transitioning between compressed and expanded configurations, and facilitate compressing the valve frame in a low, nested profile for advancement through the body of a patient.
Claims 1-14, 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6 of U.S. Patent No. 11,344,413 in view of Chambers (U.S. Pub. No. 2018/0200049). Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6 of U.S. Patent No. 11,344,413 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Alkhatib (U.S. Pub. No. 2010/0249911). Claims 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6 of U.S. Patent No. 11,344,413 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Forster (U.S. Pub. No. 2005/0203614). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that subject matter recited in the application claims are encompassed by the patent claims, except for features that are merely obvious.
Chambers teaches compressing a flow control component 305 and a valve frame (valve 300 is “stented”) laterally along a lateral axis of the valve frame that is perpendicular to a central axis such that a lateral width of the valve frame is less than a lumen diameter of catheter 304 (Figures 3A-3B, 5A-5B, [0048]-[0049], [0052]; since the valve 300 in the expanded configuration has an oversized frame along a lateral axis of the valve frame perpendicular to the central axis to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis, the valve frame is compressed as claimed in order to be loaded into the catheter), and compressing the valve frame vertically along the central axis such that a height of the valve frame is less than the lumen diameter (Id.; since the valve in the expanded configuration has an oversized frame vertically along the central axis of the valve frame to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the central axis, the valve frame is compressed as claimed in order to be loaded into the catheter). Chambers teaches the lateral width and the height of the prosthetic heart valve in the compressed configuration are a first lateral width and a first height (as in Figure 3A; the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis and the central axis, so the valve frame is compressed as claimed to a first lateral width and a first height in order to be loaded into the catheter), respectively, the prosthetic heart valve in the expanded configuration having a second lateral width along the lateral axis that is greater than the lumen diameter and a second height along the central axis that is greater than the lumen diameter (as in Figure 3B; the valve in the expanded configuration has an oversized frame along the lateral axis and the central axis of the valve frame, so the valve frame has a second lateral width and a second height to allow expansion anchoring within a heart chamber), and inserting the prosthetic heart valve 300 in the compressed configuration into the lumen of the delivery catheter such that a longitudinal axis of the valve frame is substantially parallel to a lengthwise cylindrical axis of the lumen of the delivery catheter (Figures 3A-3B, 5A-5B, [0052], [0054], [0055]; since the valve is delivered in a sideways orientation), the longitudinal axis of the valve frame being perpendicular to each of the central axis and the lateral axis (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with the above features, as taught by Chambers, in order to lower the profile of the heart valve during advancement to facilitate deploying the valve.
In the same field of art, namely prosthetic heart valves for delivery, Alkhatib teaches in Figure 7, [0060], [0063] a valve frame forming a plurality of wire (strut) cells 222, 224, 226 having an orientation and cell geometry configured to minimize strain associated with the valve frame being compressed along a central axis (the cells close along their length, or along a central axis, wherein a particular design for the cells reduces strain during collapsing/compressing; Id.)
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with a plurality of wire cells as claimed, as taught by Alkhatib, in order to reduce strain during compressing which reduces the likelihood that the wire cells deform or get damaged.
Forster teaches in Figures 3D-3E and [0145] a valve frame including two panels 36c and 36a or 36b, and compressing the valve frame laterally includes folding the valve frame laterally so that the two panels are approximately parallel (when nested) and compressing a valve frame includes folding the valve along a distal fold area (near one of hinges 58) of the valve frame and along a proximal fold area (near opposite hinge 58) of the valve frame.
It would have been obvious to one of ordinary skill before the effective filing date to modify the valve frame of Chambers with two panels and folding the valve frame along a distal fold area of the valve frame and along a proximal fold area of the valve frame as taught by Forster, in order to facilitate transitioning between compressed and expanded configurations, and facilitate compressing the valve frame in a low, nested profile for advancement through the body of a patient.
Claims 1-14, 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,186,187 in view of Chambers (U.S. Pub. No. 2018/0200049). Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,186,187 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Alkhatib (U.S. Pub. No. 2010/0249911). Claims 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,186,187 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Forster (U.S. Pub. No. 2005/0203614). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that subject matter recited in the application claims are encompassed by the patent claims, except for features that are merely obvious.
Chambers teaches compressing a flow control component 305 and a valve frame (valve 300 is “stented”) laterally along a lateral axis of the valve frame that is perpendicular to a central axis such that a lateral width of the valve frame is less than a lumen diameter of catheter 304 (Figures 3A-3B, 5A-5B, [0048]-[0049], [0052]; since the valve 300 in the expanded configuration has an oversized frame along a lateral axis of the valve frame perpendicular to the central axis to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis, the valve frame is compressed as claimed in order to be loaded into the catheter), and compressing the valve frame vertically along the central axis such that a height of the valve frame is less than the lumen diameter (Id.; since the valve in the expanded configuration has an oversized frame vertically along the central axis of the valve frame to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the central axis, the valve frame is compressed as claimed in order to be loaded into the catheter). Chambers teaches the lateral width and the height of the prosthetic heart valve in the compressed configuration are a first lateral width and a first height (as in Figure 3A; the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis and the central axis, so the valve frame is compressed as claimed to a first lateral width and a first height in order to be loaded into the catheter), respectively, the prosthetic heart valve in the expanded configuration having a second lateral width along the lateral axis that is greater than the lumen diameter and a second height along the central axis that is greater than the lumen diameter (as in Figure 3B; the valve in the expanded configuration has an oversized frame along the lateral axis and the central axis of the valve frame, so the valve frame has a second lateral width and a second height to allow expansion anchoring within a heart chamber), inserting the prosthetic heart valve 300 in the compressed configuration into the lumen of the delivery catheter such that a longitudinal axis of the valve frame is substantially parallel to a lengthwise cylindrical axis of the lumen of the delivery catheter (Figures 3A-3B, 5A-5B, [0052], [0054], [0055]; since the valve is delivered in a sideways orientation), the longitudinal axis of the valve frame being perpendicular to each of the central axis and the lateral axis (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claim with the above features, as taught by Chambers, in order to lower the profile of the heart valve during advancement to facilitate deploying the valve.
In the same field of art, namely prosthetic heart valves for delivery, Alkhatib teaches in Figure 7, [0060], [0063] a valve frame forming a plurality of wire (strut) cells 222, 224, 226 having an orientation and cell geometry configured to minimize strain associated with the valve frame being compressed along a central axis (the cells close along their length, or along a central axis, wherein a particular design for the cells reduces strain during collapsing/compressing; Id.)
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claim with a plurality of wire cells as claimed, as taught by Alkhatib, in order to reduce strain during compressing which reduces the likelihood that the wire cells deform or get damaged.
Forster teaches in Figures 3D-3E and [0145] a valve frame including two panels 36c and 36a or 36b, and compressing the valve frame laterally includes folding the valve frame laterally so that the two panels are approximately parallel (when nested) and compressing a valve frame includes folding the valve along a distal fold area (near one of hinges 58) of the valve frame and along a proximal fold area (near opposite hinge 58) of the valve frame.
It would have been obvious to one of ordinary skill before the effective filing date to modify the valve frame of Chambers with two panels and folding the valve frame along a distal fold area of the valve frame and along a proximal fold area of the valve frame as taught by Forster, in order to facilitate transitioning between compressed and expanded configurations, and facilitate compressing the valve frame in a low, nested profile for advancement through the body of a patient.
Claims 1-14, 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 10 of U.S. Patent No. 12,310,850 in view of Chambers (U.S. Pub. No. 2018/0200049). Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10 of U.S. Patent No. 12,310,850 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Alkhatib (U.S. Pub. No. 2010/0249911). Claims 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10 of U.S. Patent No. 12,310,850 in view of Chambers (U.S. Pub. No. 2018/0200049), and further in view of Forster (U.S. Pub. No. 2005/0203614). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that subject matter recited in the application claims are encompassed by the patent claims, except for features that are merely obvious.
Chambers teaches compressing a flow control component 305 and a valve frame (valve 300 is “stented”) laterally along a lateral axis of the valve frame that is perpendicular to a central axis such that a lateral width of the valve frame is less than a lumen diameter of catheter 304 (Figures 3A-3B, 5A-5B, [0048]-[0049], [0052]; since the valve 300 in the expanded configuration has an oversized frame along a lateral axis of the valve frame perpendicular to the central axis to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis, the valve frame is compressed as claimed in order to be loaded into the catheter), and compressing the valve frame vertically along the central axis such that a height of the valve frame is less than the lumen diameter (Id.; since the valve in the expanded configuration has an oversized frame vertically along the central axis of the valve frame to allow expansion anchoring within a heart chamber, and the inner diameter of the lumen of the catheter is smaller than the heart chamber along the central axis, the valve frame is compressed as claimed in order to be loaded into the catheter). Chambers teaches the lateral width and the height of the prosthetic heart valve in the compressed configuration are a first lateral width and a first height (as in Figure 3A; the inner diameter of the lumen of the catheter is smaller than the heart chamber along the lateral axis and the central axis, so the valve frame is compressed as claimed to a first lateral width and a first height in order to be loaded into the catheter), respectively, the prosthetic heart valve in the expanded configuration having a second lateral width along the lateral axis that is greater than the lumen diameter and a second height along the central axis that is greater than the lumen diameter (as in Figure 3B; the valve in the expanded configuration has an oversized frame along the lateral axis and the central axis of the valve frame, so the valve frame has a second lateral width and a second height to allow expansion anchoring within a heart chamber), inserting the prosthetic heart valve 300 in the compressed configuration into the lumen of the delivery catheter such that a longitudinal axis of the valve frame is substantially parallel to a lengthwise cylindrical axis of the lumen of the delivery catheter (Figures 3A-3B, 5A-5B, [0052], [0054], [0055]; since the valve is delivered in a sideways orientation), the longitudinal axis of the valve frame being perpendicular to each of the central axis and the lateral axis (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with the above features, as taught by Chambers, in order to lower the profile of the heart valve during advancement to facilitate deploying the valve.
In the same field of art, namely prosthetic heart valves for delivery, Alkhatib teaches in Figure 7, [0060], [0063] a valve frame forming a plurality of wire (strut) cells 222, 224, 226 having an orientation and cell geometry configured to minimize strain associated with the valve frame being compressed along a central axis (the cells close along their length, or along a central axis, wherein a particular design for the cells reduces strain during collapsing/compressing; Id.)
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with a plurality of wire cells as claimed, as taught by Alkhatib, in order to reduce strain during compressing which reduces the likelihood that the wire cells deform or get damaged.
Forster teaches in Figures 3D-3E and [0145] a valve frame including two panels 36c and 36a or 36b, and compressing the valve frame laterally includes folding the valve frame laterally so that the two panels are approximately parallel (when nested) and compressing a valve frame includes folding the valve along a distal fold area (near one of hinges 58) of the valve frame and along a proximal fold area (near opposite hinge 58) of the valve frame.
It would have been obvious to one of ordinary skill before the effective filing date to modify the valve frame of Chambers with two panels and folding the valve frame along a distal fold area of the valve frame and along a proximal fold area of the valve frame as taught by Forster, in order to facilitate transitioning between compressed and expanded configurations, and facilitate compressing the valve frame in a low, nested profile for advancement through the body of a patient.
Allowable Subject Matter
Claims 1-13 would be allowable if a Terminal Disclaimer is filed to overcome the double patenting rejections set forth in this office action.
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior art of record, alone or in combination, teaches or renders obvious a prosthetic heart valve including, inter alia, a valve frame having a central axis and defining an aperture extending along the central axis, the valve frame having a tension arm extending laterally therefrom, the valve frame having an expanded configuration with a first height along a central axis and a first lateral width along a lateral axis perpendicular to the central axis, the valve frame having a compressed configuration with a second height along the central axis that is less than the first height and a second lateral width along the lateral axis that is less than the first lateral width, wherein the prosthetic heart valve is configured to be disposed in an annulus of a native heart valve such that a portion of the valve frame including the tension arm is disposed below an annulus in a ventricle of the heart, as in claim 1.
None of the prior art of record, alone or in combination, teaches or renders obvious a method of delivering a prosthetic heart valve to an annulus of a native heart valve including, inter alia, disposing in an atrium of a heart a distal portion of a delivery catheter, the delivery catheter having disposed within a lumen thereof the prosthetic heart valve in a compressed configuration such that a distal subannular tension arm is disposed toward a distal end of the delivery catheter; advancing at least a distal portion of the prosthetic heart valve beyond the distal end of the delivery catheter to place at least a portion of the distal subannular tension arm on a ventricle side of the annulus while at least a proximal subannular portion of the valve frame remains on an atrium side of the annulus, as in claim 8.
The closest prior art of record Chambers (U.S. Pub. No. 2018/0200049) discloses a device and method similar to the claimed inventions, as discussed above, except for a prosthetic heart valve that is configured to be disposed in an annulus of a native heart valve such a tension arm extending from the frame is disposed below an annulus in a ventricle of a heart, or a method of delivering a prosthetic heart valve such that a distal subannular tension arm is placed on a ventricle side of an annulus of a native heart valve. Chambers teaches it is undesirable to have such structures below the heart valve annulus ([0015]-[0017]) as 2-chamber solutions including deploying a subannular ventricular structure are unnecessarily bulky and more difficult to deliver, position, recapture, reposition, and anchor, and may interfere with native valve functionality. Therefore, a skilled artisan would not have found it obvious to modify Chambers with a subannular tension arm as claimed.
Conclusion
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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