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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/5/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have have been considered but are moot in view of the new grounds for rejection.
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 1-6, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tegels et al. (Pub. No.: US 2014/0296969) in view of Tuval et al. (Pub. No.: US 2020/0030092).
Tegels discloses an implantable heart-valve apparatus (abstract), comprising:
a tubular braided frame 10 (e.g., para. 99), comprising a body 10 having an inflow end (fig. 7, end near label 14) and an outflow end (fig. 7, end near label 26);
wherein the tubular braided frame extends outwardly from the body to form at least one flange 12, wherein at least a portion of the flange comprises a fabric covering (fig. 7, e.g., para. 37) configured to seal against atrial tissue (e.g., para. 62), and wherein the at least one flange and the fabric covering define a sealing skirt with a terminal end spaced longitudinally apart from the body along an axis extending through the tubular braided frame (e.g., fig. 7, 8A-B); and
wherein the tubular braided frame extends out from near the outflow end to form engagement attachments 110 comprising a leaflet anchor 110 and two shape set stabilization anchors (not disclosed), wherein the engagement attachments are integrated with the tubular braided frame to define a single component (e.g., fig. 9, para. 140), wherein the leaflet anchor is disposed between the two shape set stabilization anchors (not disclosed).
As provided in italicized text above, Tegels lacks two shape set stabilization anchors, wherein the leaflet anchor is disposed between the two shape set stabilization anchors. Tuval et al. (hereinafter, Tuval) teaches a leaflet anchor 106 and two shape set (e.g., para. 128) stabilization anchors 121 (e.g., fig. 11A) as anchors on a mitral valve prosthesis (e.g., fig. 11B) in order to prevent systolic anterior motion of the native leaflets, thereby preventing the native leaflets from blocking or interfering with the left ventricular outflow tract (e.g., para. 161). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have substituted the engagement attachments of Tegels with the leaflet anchor and two shape set stabilization anchors of Tuval for the purpose of providing unobstructed blood flow to the left ventricular outflow tract. This modification would have occurred using known methods and would have yielded predictable results.
For claim 2, Tegels in view of Tuval teach the apparatus of claim 1, wherein at least one of the engagement attachments is grafted onto the tubular braided frame (Tegels fig. 7, Tuval fig. 11B).
For claim 3, Tegels and Tuval fail to specify the apparatus of claim 1, wherein at least one of the engagement attachments is welded onto the tubular braided frame, however, welded attachments are well known connections in the stent art and it would have been obvious to one of ordinary skill in the art to have selected a welded attachment for the attachment seen in Tuval figure 11B as an obvious expedient.
For claim 4, Tegels in view of Tuval teach the apparatus of claim 1, wherein the tubular braided frame comprises a first wire and at least one of the engagement attachments comprises a second wire attached to the first wire (e.g., Tegels fig. 7, Tuval fig. 11B).
For claim 5, Tegels in view of Tuval teach the apparatus of claim 1, wherein the two shape set stabilization anchors are between 120 to 180 degrees apart (e.g., Tuval fig. 11A).
For claim 6, Tegels in view of Tuval teach the apparatus of claim 1, wherein the tubular braided frame contains a replacement heart valve (e.g., Tegels para. 6).
For claim 19, Tegels in view of Tuval teach the apparatus of claim 1, wherein the fabric covering extends continuously along the at least one flange (e.g., Tegels, fig. 7).
For claim 20, Tegels in view of Tuval teach the apparatus of claim 1, wherein the sealing skirt comprises at least one wire and the fabric covering extends from the inflow end of the body along the at least one wire of the sealing skirt (e.g., Tegels, fig. 7)
Claims 7-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tegels et al. (Pub. No.: US 2014/0296969) in view of Tuval et al. (Pub. No.: US 2020/0030092), further in view of Benichou et al. (Pub. No.: US 2021/0113332).
For claim 7, Tegels discloses an implantable heart valve system (abstract), comprising:
an implantable heart-valve apparatus (abstract) comprising
a tubular braided frame 10 (e.g., para. 99) having an inflow end (fig. 7, end near label 14) and an outflow end (fig. 7, end near label 26);
a flange 12 extending from the tubular braided frame, wherein at least a portion of the flange comprises a fabric covering (fig. 7, e.g., para. 37) configured to seal against atrial tissue (e.g., para. 62), and wherein the flange has a terminal end spaced longitudinally apart from the body along an axis extending through the tubular braided frame (e.g., fig. 7, 8A-B); and
a plurality of engagement attachments 110 extending out from proximate the outflow end, the engagement attachments comprising a leaflet anchor 110 and two shape set stabilization anchors (not disclosed), wherein the leaflet anchor is disposed between the two shape set stabilization anchors, wherein the tubular braided frame and the plurality of engagement attachments define a singular component (e.g., fig. 9, para. 140);
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, Tegels lacks two shape set stabilization anchors, wherein the leaflet anchor is disposed between the two shape set stabilization anchors. Tuval teaches a leaflet anchor 106 and two shape set (e.g., para. 128) stabilization anchors 121 (e.g., fig. 11A) as anchors on a mitral valve prosthesis (e.g., fig. 11B) in order to prevent systolic anterior motion of the native leaflets, thereby preventing the native leaflets from blocking or interfering with the left ventricular outflow tract (e.g., para. 161). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have substituted the engagement attachments of Tegels with the leaflet anchor and two shape set stabilization anchors of Tuval for the purpose of providing unobstructed blood flow to the left ventricular outflow tract. This modification would have occurred using known methods and would have yielded predictable results.
As further provided by italicized text, Tegels and Tuval lacks a delivery component comprising one or more suture lines connected to the implant and to the delivery component. Benichou teaches sutures interconnecting implant and delivery device (e.g., fig. 6) as an obvious interconnection between the delivery device and implant. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have utilized a delivery component with sutures as taught by Benichou as an obvious expedient to interconnect the implant with the delivery component. This modification would have occurred using known methods and would have yielded predictable results.
For claim 8, Tegels in view of Tuval teach the system of claim 7, wherein at least one of the engagement attachments is grafted onto the tubular braided frame (Tegels fig. 7, Tuval fig. 11B).
For claim 9, Tegels and Tuval fail to specify the system of claim 7, wherein at least one of the engagement attachments is welded onto the tubular braided frame, however, welded attachments are well known connections in the stent art and it would have been obvious to one of ordinary skill in the art to have selected a welded attachment for the attachment seen in Tuval figure 11B as an obvious expedient.
For claim 10, Tegels in view of Tuval teach the system of claim 7, wherein the tubular braided frame comprises a first wire and at least one of the engagement attachments comprises a second wire attached to the first wire (e.g., Tegels fig. 7, Tuval fig. 11B).
For claim 11, Tegels in view of Tuval teach the system of claim 7, wherein the two shape set stabilization anchors are between 120 to 180 degrees apart (e.g., Tuval fig. 11A).
For claim 12, Tegels discloses a method for percutaneous deployment and placement of an implantable heart-valve apparatus (abstract), comprising:
an implantable heart-valve apparatus 10 and a delivery component (abstract),
wherein the implantable heart-valve apparatus comprises a tubular braided frame 10 (e.g., para. 99)-
having a body with an inflow end (fig. 7, end near label 14) and an outflow end (fig. 7, end near label 26),
wherein the tubular braided frame extends outwardly from the body to form at least one flange 12 (e.g., fig. 7),
wherein at least a portion of the flange comprises a fabric covering (fig. 7, e.g., para. 37) configured to seal against atrial tissue (e.g., para. 62),
wherein the at least one flange has a terminal end spaced longitudinally apart from the body along an axis extending through the tubular braided frame (e.g., fig. 7, 8A-B),
wherein the tubular braided frame extends out to form engagement attachments 110 comprising a leaflet anchor 110 and two shape set stabilization anchors (not disclosed), wherein the leaflet anchor is disposed between the two shape set stabilization anchors, 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., fig. 9, para. 140);
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., abstract)
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. 20); 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.
As provided in italicized text above, Tegels lacks two shape set stabilization anchors, wherein the leaflet anchor is disposed between the two shape set stabilization anchors. Tuval teaches a leaflet anchor 106 and two shape set (e.g., para. 128) stabilization anchors 121 (e.g., fig. 11A) as anchors on a mitral valve prosthesis (e.g., fig. 11B) in order to prevent systolic anterior motion of the native leaflets, thereby preventing the native leaflets from blocking or interfering with the left ventricular outflow tract (e.g., para. 161). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have substituted the engagement attachments of Tegels with the leaflet anchor and two shape set stabilization anchors of Tuval for the purpose of providing unobstructed blood flow to the left ventricular outflow tract. This modification would have occurred using known methods and would have yielded predictable results.
As further provided by italicized text, Tegels and Tuval lacks a delivery component comprising one or more suture lines connected to the implant and to the delivery component. Benichou teaches sutures interconnecting implant and delivery device (e.g., fig. 6) as an obvious interconnection between the delivery device and implant. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have utilized a delivery component with sutures as taught by Benichou as an obvious expedient to interconnect the implant with the delivery component. This modification would have occurred using known methods and would have yielded predictable results.
For claim 13, Tegels in view of Tuval teach the method of claim 12, wherein at least one of the engagement attachments is grafted onto the tubular braided frame (Tegels fig. 7, Tuval fig. 11B).
For claim 14, Tegels and Tuval fail to specify the method of claim 12, wherein at least one of the engagement attachments is welded onto the tubular braided frame, however, welded attachments are well known connections in the stent art and it would have been obvious to one of ordinary skill in the art to have selected a welded attachment for the attachment seen in Tuval figure 11B as an obvious expedient.
For claim 15, Tegels in view of Tuval teach 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. 55, 111).
For claim 16, Tegels in view of Tuval teach the method of claim 12, wherein the tubular braided frame comprises a first wire and at least one of the engagement attachments comprises a second wire attached to the first wire (e.g., Tegels fig. 7, Tuval fig. 11B).
For claim 17, Tegels in view of Tuval teach the method of claim 12, wherein the two shape set stabilization anchors are between 120 to 180 degrees apart (e.g., Tuval, fig. 11A).
For claim 18, Tegels in view of Tuval teach the method of claim 12, wherein the tubular braided frame is a receiver for a replacement heart valve 14 (Tegels fig. 7).
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
