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 .
Response to Arguments
Applicant’s arguments with respect to claims 1-18 have been considered but are moot in view of the new grounds for rejection. Applicant has amended claims 1, 7, and 12 to recite at least a portion of the flange comprises a fabric covering configured to seal against atrial tissue. In response to Applicant’s amendment, Examiner now cites Ratz et al. (Pub. No.: US 2014/0277390).
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, 5, 7, 11, 12, 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 11, 12, 17 of U.S. Patent No. 12,575,928. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader than the patent claims. All of the elements of application claims 1, 5, 7, 11, 12, and 17 are found in patent claims 1, 5, 7, 11, 12, and 17. The difference between the claims is that the patent claims include many more elements and thus are much more specific. Thus the invention of claims 1, 5, 7, 11, 12, and 17 of the patent is in effect a “species” of the “generic” invention of application claims 1, 5, 7, 11, 12, and 17. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims 1, 5, 7, 11, 12, and 17 are anticipated by patent claims 1, 5, 7, 11, 12, and 17, the claims are not patentably distinct.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Figulla et al. (Pub. No.: US 2014/0088696) in view of Ratz et al. (Pub. No.: US 2014/0277390).
Figulla et al. (hereinafter Figulla) discloses an implantable heart-valve apparatus (e.g., fig. 1), comprising:
a tubular braided (e.g., para. 19) frame, wherein the tubular braided frame comprises an inflow end (end with atrial side anchoring elements 6a-d) and an outflow end (end with ventricular-side anchoring members 4a-d);
wherein the tubular braided frame extends out to form at least one flange (fig. 1), wherein at least a portion of the flange comprises a fabric covering configured to seal against atrial tissue (not disclosed); and
wherein the tubular braided frame extends out from the outflow end to form engagement attachments 4a-d comprising a leaflet anchor 4b, 4c (e.g., fig. 2) and two shape set stabilization anchors 4a, 4d (e.g., fig. 2), wherein the engagement attachments are integrated with the tubular braided frame to define a single component (fig. 1), wherein the leaflet anchor is disposed between the two shape set stabilization anchors (fig. 1, 2).
As provided in italicized text above, Figulla lacks a portion of the flange comprising a fabric covering configured to seal against atrial tissue. Ratz et al. (hereinafter, Ratz) teaches a mitral valve prosthesis including a fabric covering 30 (fig. 6) attached to a flange 22 and which seals against atrial tissue (fig. 6). Ratz teaches that the skirt 30 beneficially prevents axial fluid flow around the exterior of the prosthesis (para. 57-58). Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided Figulla with a skirt configured to seal against atrial tissue as taught by Ratz for the purpose of preventing leakage around the exterior of the prosthetic valve. This modification would have occurred using known methods and would have yielded predictable results.
For claim 5, Figulla discloses the apparatus of claim 1, wherein the two shape set stabilization anchors are between 120 to 180 degrees apart (e.g., fig. 1, 2).
For claim 6, Figulla discloses the apparatus of claim 1, wherein the tubular braided frame contains a replacement heart valve (e.g., para. 23).
Claims 7, 11-12, 15, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Figulla et al. (Pub. No.: US 2014/0088696) in view of Chang et al. (Pub. No.: US 2017/0156859) and Ratz et al. (Pub. No.: US 2014/0277390).
For claim 7, Figulla discloses an implantable heart valve system, comprising:
an implantable heart-valve apparatus (e.g., fig. 1) comprising
a tubular braided (e.g., para. 19) frame, having an inflow end (end with atrial side anchoring elements 6a-d) and an outflow end (end with ventricular-side anchoring members 4a-d);
a flange extending from the tubular braided frame (fig. 1), wherein at least a portion of the flange comprises a fabric covering configured to seal against atrial tissue (not disclosed); and
a plurality of engagement attachments 4a-d extending out from the outflow end, the engagement attachments comprising a leaflet anchor 4b. 4c (e.g., fig. 2) and two shape set stabilization anchors 4a, 4d (e.g., fig. 2), wherein the leaflet anchor is disposed between the two shape set stabilization anchors (e.g., fig. 1), wherein the tubular braided frame and the plurality of engagement attachments define a singular component (e.g., fig. 1);
a delivery component comprising one or more suture lines connected on a first end to the implantable heart-valve apparatus;
wherein the one or more suture lines connects on a second end to the delivery component (not disclosed).
As provided in italicized text above, Figulla lacks a portion of the flange comprising a fabric covering configured to seal against atrial tissue. Ratz et al. (hereinafter, Ratz) teaches a mitral valve prosthesis including a fabric covering 30 (fig. 6) attached to a flange 22 and which seals against atrial tissue (fig. 6). Ratz teaches that the skirt 30 beneficially prevents axial fluid flow around the exterior of the prosthesis (para. 57-58). Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided Figulla with a skirt configured to seal against atrial tissue as taught by Ratz for the purpose of preventing leakage around the exterior of the prosthetic valve. This modification would have occurred using known methods and would have yielded predictable results.
As provided in italicized text above, Figulla lacks a delivery component with one ore more suture lines connected on a first end to the implantable heart valve apparatus and on a second end to the delivery component. Figulla does include rings 4’ and 6’ on the end of each anchoring element, however, Figulla does not suggest that these rings are used for a suture line interconnected with a delivery component. Chang et al. (hereinafter, Change) teaches interconnecting a delivery catheter with a heart valve implant using suture loops 172 interconnected with a delivery catheter 104 for the purpose of providing control over the expansion and compression of the prosthetic valve (e.g., para. 79). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the Figulla implant with suture loops and a delivery catheter as taught by Chang for the purpose of providing reversible control over the deployment of the prosthetic valve, ensuring more accurate placement. This modification would have occurred using known methods and would have yielded predictable results.
For claim 11, Figulla discloses the system of claim 7, wherein the two shape set stabilization anchors are between 120 to 180 degrees apart (e.g., fig. 1, 2).
For claim 12, Figulla discloses a method for percutaneous deployment and placement (e.g., para. 5) of an implantable heart-valve apparatus, comprising:
an implantable heart-valve apparatus 2 and a delivery component (e.g., para. 5);
wherein the implantable heart-valve apparatus comprises a tubular braided frame (e.g., para. 19), an inflow end (end with atrial side anchoring elements 6a-d) and an outflow end (end with ventricular-side anchoring members 4a-d);
wherein the tubular braided frame extends out to form at least one flange (fig. 1); and
wherein at least a portion of the flange comprises a fabric covering configured to seal against atrial tissue,
wherein the tubular braided frame extends out from the outflow end to form engagement attachments 4a-d comprising a leaflet anchor4b, 4c and two shape set stabilization anchors 4a, 4d (e.g., fig. 2), wherein the leaflet anchor is disposed between the two shape set stabilization anchors (e.g., fig. 1), wherein the tubular braided frame and at least one of the two shape set stabilization anchors are integrally formed as a single component (e.g., para. 17);
wherein the delivery component comprises one or more suture lines and wherein the one or more suture lines goes through the heart-valve apparatus and connects to the delivery component (not disclosed);
percutaneously placing the implantable heart-valve apparatus into one of a vein or an artery (e.g., para. 26);
delivering the implantable heart-valve apparatus to a native heart valve; placing the implantable heart-valve apparatus in the position of the native heart valve (e.g., para. 26); and
expanding the engagement attachments by releasing one or more of the suture lines (not disclosed),
wherein when deployed in a native valve comprising a native annulus and one or more native leaflets, the leaflet anchor engages behind the one or more native leaflets and the two shape set stabilization anchors extend towards the native annulus (e.g., fig. 2).
As provided in italicized text above, Figulla lacks a portion of the flange comprising a fabric covering configured to seal against atrial tissue. Ratz et al. (hereinafter, Ratz) teaches a mitral valve prosthesis including a fabric covering 30 (fig. 6) attached to a flange 22 and which seals against atrial tissue (fig. 6). Ratz teaches that the skirt 30 beneficially prevents axial fluid flow around the exterior of the prosthesis (para. 57-58). Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided Figulla with a skirt configured to seal against atrial tissue as taught by Ratz for the purpose of preventing leakage around the exterior of the prosthetic valve. This modification would have occurred using known methods and would have yielded predictable results.
As provided in italicized text above, Figulla lacks a delivery component with one ore more suture lines connected on a first end to the implantable heart valve apparatus and on a second end to the delivery component, and the method step of expanding the engagement attachments by releasing one or more of the suture lines. Figulla does include rings 4’ and 6’ on the end of each anchoring element, however, Figulla does not suggest that these rings are used for a suture line interconnected with a delivery component. Chang et al. (hereinafter, Change) teaches interconnecting a delivery catheter with a heart valve implant using suture loops 172 interconnected with a delivery catheter 104 for the purpose of providing control over the expansion and compression of the prosthetic valve (e.g., para. 79). These suture loops engage openings on the heart valve prosthesis and allow for expansion by releasing the suture lines (e.g., para. 79). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the Figulla implant with suture loops and a delivery catheter as taught by Chang for the purpose of providing reversible control over the deployment of the prosthetic valve, ensuring more accurate placement. It would have been obvious to one of ordinary skill in the art to have provided the suture line son the engagement attachments as an obvious location to control the expansion and contraction of the engagement attachments during implant delivery. This modification would have occurred using known methods and would have yielded predictable results.
For claim 15, Figulla discloses the method of claim 12, wherein the vein is a femoral vein and wherein delivering the implantable heart-valve apparatus to a native heart valve comprises delivering the implantable heart-valve apparatus through the vena cava and through a puncture in the atrial septum (e.g., para. 27). Use of the femoral vein to access the trans-septal implant procedure is considered an obvious expedient.
For claim 17, Figulla discloses the method of claim 12, wherein the two shape set stabilization anchors are between 120 to 180 degrees apart (fig. 1).
For claim 18, Figulla discloses the method of claim 12, wherein the tubular braided frame is a receiver for a replacement heart valve (abstract).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Figulla et al. (Pub. No.: US 2014/0088696) in view of Ratz et al. (Pub. No.: US 2014/0277390), further in view of Haug et al. (Pub. No.: US 2005/0137693).
For claims 2-4, Figulla does not specify the engagement attachments are grafted on the tubular braided frame, are welded onto the frame, or comprise a tubular braided frame first wire and an engagement attachment second wire attached to the first wire. Figulla does teach the engagement attachments are integral to the tubular braided frame (para. 17), and welding is a known means of providing an integral attachment. Additionally, Haug et al. (hereinafter, Haug) teaches welded ends on a braided prosthesis as a suitable attachment (e.g., fig. 7A-J). Haug further teaches braiding two wires, where the tubular body is a first wire and an engagement attachment is a second wire (e.g., fig. 10C). This is considered a grafted engagement attachment. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided Figulla with multiple wire braids, grafted engagement attachments, and welds as taught by Haug as an obvious expedient to provide the integral braided structure of Figulla. This modification would have occurred using known methods and would have yielded predictable results.
Claims 8-10, 13-14, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Figulla et al. (Pub. No.: US 2014/0088696) in view of Chang et al. (Pub. No.: US 2017/0156859) and Ratz et al. (Pub. No.: US 2014/0277390), further in view of Haug et al. (Pub. No.: US 2005/0137693).
For claims 8-10, 13-14, 16, Figulla and Chen do not specify the engagement attachments are grafted on the tubular braided frame, are welded onto the frame, or comprise a tubular braided frame first wire and an engagement attachment second wire attached to the first wire. Figulla does teach the engagement attachments are integral to the tubular braided frame (para. 17), and welding is a known means of providing an integral attachment. Additionally, Haug teaches welded ends on a braided prosthesis as a suitable attachment (e.g., fig. 7A-J). Haug further teaches braiding two wires, where the tubular body is a first wire and an engagement attachment is a second wire (e.g., fig. 10C). This is considered a grafted engagement attachment. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided Figulla and Chen with multiple wire braids, grafted engagement attachments, and welds as taught by Haug as an obvious expedient to provide the integral braided structure of Figulla. This modification would have occurred using known methods and would have yielded predictable results.
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.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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