DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 04/14/2026.
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 § 112
The rejection of claim(s) 9, 11-12, 14, 21, 22-26, and 30 in the previous Office Action under this section, 2nd paragraph (pre-AIA ) or subsection (b) (AIA ), for being indefinite is hereby withdrawn in view of Applicant’s Amendment.
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.
Claim(s) 22-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2011/0319988 A1 to Schankereli et al. (hereinafter “Schankereli”) (previously of record).
Regarding claim 22, Schankereli discloses (see abstract; Figs. 1-13; and [0077]-[0164]) a device (as shown in Figs. 1-13) for assisting the functioning of a heart valve (see at least [0077]-[0078]), comprising: a valve assembly (as shown in Fig. 1) comprising a tubular braided frame (112, see Fig. 1 and [0125]-[0126]), wherein the valve assembly comprises inflow end (near #110, Fig. 1) and an outflow end (near #114, Fig. 1); at least one commissure tab (146) (see Figs. 3E/6 and [0138] and [0104]); and a leaflet assembly (120) connected to the at least one commissure tab (see [0138] and [0097]-[0099]), wherein the leaflet assembly is configured to provide a seal between the inflow end and the outflow end of the tubular braided frame (see [0099]).
Schankereli further discloses (claim 23) wherein the tubular braided frame further comprises at least one braided wire wound in a helical spiral direction (see [0092]/[0095]), wherein the helical spiral direction begins at the inflow end and ends at the outflow end (see [0092]/[0095]); and wherein the tubular braided frame is configured to lengthen and compress in relation to a heart contraction (see [0092]/[0093]; [0095]/[0096]; and [0085]-[0090], the braided frame is made of the same nitinol wire as the cuff, the discussion about the cuff being able to lengthen and compress in response to heart contraction or other forces imposed on it would be understood to be equally applicable to the braided frame); (claim 24) wherein the valve assembly comprises a first material type of wire, wherein the first material type of wire comprises a first wire type (nitinol or other alloys listed at [0092], see [0092]/[0093] and [0095]/[0096]); (claim 25) wherein a layer of material extends over one or both of an outside portion of the valve assembly and an inside portion of the valve assembly (see [0113] and [0136]); and (claim 26) wherein the tubular braided frame is configured to exert a radial force when in a compressed state; wherein the tubular braided frame is configured to self-expand from a compressed state when the device is delivered to the heart valve (see [0093]/[0126]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9, 10, 13, 15-21, and 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schankereli in view of US 2011/0137397 A1 to Chau et al. (hereinafter “Chau”) (cited in an IDS dated 06/18/2026).
Regarding claim 1, Schankereli discloses (see abstract; Figs. 1-13; and [0077]-[0164]) a device (as shown in Figs. 1-13) for assisting the functioning of a heart valve (see at least [0077]-[0078]), comprising: a tubular braided frame (112, see Fig. 1 and [0125]-[0126]) comprising an inflow end portion (near #110, Fig. 1) and an outflow end portion (near #114, Fig. 1); a flange structure (116) at the inflow end of the tubular braided frame (see Fig. 1); and a leaflet assembly (120) connected to the tubular braided frame (see [0138] and [0097]-[0099]), wherein the leaflet assembly is configured to provide a seal between the inflow end and the outflow end of the tubular braided frame (see [0099]).
Schankereli further discloses (claim 2) wherein the tubular braided frame further comprises at least one braided wire wound in a helical spiral direction (see [0092]/[0095]), wherein the helical spiral direction begins at the inflow end and ends at the outflow end (see [0092]/[0095]); and wherein the tubular braided frame is configured to lengthen and compress in relation to a heart contraction (see [0092]/[0093]; [0095]/[0096]; and [0085]-[0090], the braided frame is made of the same nitinol wire as the cuff, the discussion about the cuff being able to lengthen and compress in response to heart contraction or other forces imposed on it would be understood to be equally applicable to the braided frame); (claim 3) wherein the at least one braided wire comprises a first material type of wire, wherein the first material type of wire comprises a first wire type (nitinol or other alloys listed at [0092], see [0092]/[0093] and [0095]/[0096]); (claim 4) wherein the flange structure comprises one or both of the first wire type and a second material type of wire, wherein the second material type of wire comprises a second wire type (see [0086]/[0090], can be nitinol or other alloys listed at [0090], thus allowing the braided frame wire to be either the same or different material as the flange wire); (claim 6) wherein a layer of material extends over one or more of the following: an outside portion of the tubular braided frame, an inside portion of the tubular braided frame, a top portion of the flange structure, a bottom portion of the flange structure (see [0113] and [0136]); (claim 7) wherein the tubular braided frame further comprises an engagement attachment, wherein the engagement attachment comprises a barb (158) (see Fig. 11 and [0147]); (claim 8) wherein the layer of material extending over the outside portion of the tubular braided frame comprises one or more belt loops at one or both of the inflow end and the outflow end of the tubular braided frame (see Figs. 5/7 showing layer of material on outside of frame (as per [0113]/[0136]) covering 114 forming a belt loop); and (claim 9) wherein the tubular braided frame is configured to self-expand from a compressed state when the device is delivered to the heart valve (see [0093]/[0126]).
Regarding claim 1, Schankereli fails to specifically disclose at least one anchor extending radially outwardly from the outflow end of the tubular braided frame and extending in a direction toward the inflow end, wherein the at least one anchor is configured to interact with native leaflets of the heart valve. Further, with respect to claim 5, Schankereli fails to specifically disclose wherein the anchor is configured to be radially overlapping with the tubular braided frame and having an inverted u-shape.
Chau discloses (see abstract; Figs. 6-9 & 23; and [0101]-[0107]) a heart valve (100) comprising a tubular frame (102), wherein the frame comprises an outflow end (112, see Fig. 6 and [0088]) and an inflow end (110, see Fig. 6 and [0088]), and further wherein at least one anchor (126) extends radially outwardly from the outflow end of the tubular braided frame and extends in a direction toward the inflow end (see Figs. 6-9 and [0101]-[0107]), the at least one anchor configured to interact with native leaflets of the heart valve (see [0101]-[0103] and Fig. 23), wherein the anchor is configured to be radially overlapping with the tubular frame and has an inverted u-shape (see Figs. 8-9 and [0107]) in the same field of endeavor for the purpose of functioning to retain the frame within a native valve region of the heart by securing the frame to the anterior and posterior mitral leaflets such that the anchors wrap around the leaflets and extend upwards between the leaflets and the ventricular walls (see [0101]/[0103]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Schankereli’s tubular frame by providing the anchors taught by Chau in order to function to retain the frame within a native valve region of the heart by securing the frame to the anterior and posterior mitral leaflets such that the anchors wrap around the leaflets and extend upwards between the leaflets and the ventricular walls.
Regarding claim 10, Schankereli discloses (see abstract; Figs. 1-13; and [0077]-[0164]) a device (as shown in Figs. 1-13) for assisting the functioning of a heart valve (see at least [0077]-[0078]), comprising: an adapter (112, see Fig. 1 and [0125]-[0126]) comprising a tubular braided adapter frame (see [0125]-[0126]) that comprises an inflow end (near #110, Fig. 1) and an outflow end (near #114, Fig. 1); a flange structure (116) at the inflow end of the tubular braided adapter frame (see Fig. 1).
Schankereli further discloses (claim 13) wherein the tubular braided frame further comprises at least one braided wire wound in a helical spiral direction (see [0092]/[0095]), wherein the helical spiral direction begins at the inflow end and ends at the outflow end (see [0092]/[0095]); and wherein the tubular braided frame is configured to lengthen and compress in relation to a heart contraction (see [0092]/[0093]; [0095]/[0096]; and [0085]-[0090], the braided frame is made of the same nitinol wire as the cuff, the discussion about the cuff being able to lengthen and compress in response to heart contraction or other forces imposed on it would be understood to be equally applicable to the braided frame); (claim 15) wherein the at least one braided wire comprises a first material type of wire, wherein the first material type of wire comprises a first wire type (nitinol or other alloys listed at [0092], see [0092]/[0093] and [0095]/[0096]); (claim 16) wherein one or both of the flange structure and the at least one anchor comprises one or both of the first wire type and a second material type of wire, wherein the second material type of wire comprises a second wire type (see [0086]/[0090], can be nitinol or other alloys listed at [0090], thus allowing the braided frame wire to be either the same or different material as the flange wire); (claim 17) wherein one or both of the flange structure and the at least anchor is configured to be radially overlapping with the tubular braided frame (see Figs. 7-8, radially overlap immediately adjacent to connection point between cuff and stent body); (claim 18) wherein a layer of material extends over one or more of the following: an outside portion of the tubular braided frame, an inside portion of the tubular braided frame, a top portion of the flange structure, a bottom portion of the flange structure, a top portion of the at least one anchor, and a bottom portion of the at least one anchor (see [0113] and [0136]); (claim 19) wherein the tubular braided frame further comprises an engagement attachment, wherein the engagement attachment comprises a barb (158) (see Fig. 11 and [0147]); (claim 20) wherein the layer of material extending over the outside portion of the tubular braided frame comprises one or more belt loops at one or both of the inflow end and the outflow end of the tubular braided frame (see Figs. 5/7 showing layer of material on outside of frame (as per [0113]/[0136]) covering 114 forming a belt loop); and (claim 21) wherein the tubular braided frame is configured to self-expand from a compressed state when the device is delivered to the heart valve (see [0093]/[0126]).
Schankereli fails to specifically disclose, with respect to claim 10, wherein the tubular adapter frame is braided; and at least one anchor at the outflow end of the tubular braided adapter frame, wherein the at least one anchor is made of a wire extending radially outwardly from the tubular braided adaptor frame and in a direction toward the inflow end, the at least one anchor having a fabric covering.
Chau discloses (see abstract; Figs. 5-9 & 23; and [0101]-[0107]) a heart valve (100) comprising a tubular frame (102), wherein the frame comprises an outflow end (112, see Fig. 6 and [0088]) and an inflow end (110, see Fig. 6 and [0088]), and further wherein at least one anchor (126) extends radially outwardly from the outflow end of the tubular braided frame and extends in a direction toward the inflow end (see Figs. 6-9 and [0101]-[0107]), the at least one anchor configured to interact with native leaflets of the heart valve (see [0101]-[0103] and Fig. 23), the at least one anchor having a fabric covering (see Figs. 5 and [0108]) in the same field of endeavor for the purpose of functioning to retain the frame within a native valve region of the heart by securing the frame to the anterior and posterior mitral leaflets such that the anchors wrap around the leaflets and extend upwards between the leaflets and the ventricular walls (see [0101]/[0103]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Schankereli’s tubular frame by providing the anchors taught by Chau in order to function to retain the frame within a native valve region of the heart by securing the frame to the anterior and posterior mitral leaflets such that the anchors wrap around the leaflets and extend upwards between the leaflets and the ventricular walls.
Regarding claim 27, Schankereli discloses (see abstract; Figs. 1-13; and [0077]-[0164]) a device (as shown in Figs. 1-13) for assisting the functioning of a heart valve (see at least [0077]-[0078]), comprising: a tubular frame (112, see Fig. 1 and [0125]-[0126]) comprising an inflow end region(near #110, Fig. 1) and an outflow end region (near #114, Fig. 1); wherein the tubular frame further comprises at least one braided wire wound in a helical spiral direction (see [0092]/[0095]), wherein the helical spiral direction begins at the inflow end and ends at the outflow end (see [0092]/[0095]); and wherein the tubular braided frame is configured to lengthen and compress in relation to a heart contraction (see [0092]/[0093]; [0095]/[0096]; and [0085]-[0090], the braided frame is made of the same nitinol wire as the cuff, the discussion about the cuff being able to lengthen and compress in response to heart contraction or other forces imposed on it would be understood to be equally applicable to the braided frame).
Schankereli further discloses (claim 28) wherein the tubular frame comprises a first material type of wire, wherein the first material type of wire comprises a first wire type (nitinol or other alloys listed at [0092], see [0092]/[0093] and [0095]/[0096]); (claim 29) wherein a layer of material extends over one or both of an outside portion of the tubular frame and an inside portion of the tubular frame (see [0113] and [0136]); and (claim 30) wherein the tubular frame comprises a radial force when in a compressed state; wherein the tubular frame is configured to expand in relation to the radial force when the device is delivered to the heart valve (see [0093]/[0126]).
Regarding claim 27, Schankereli fails to specifically disclose an anchor extending radially outward from the distal end region toward the inflow end region, wherein the anchor comprises a wire configured to extend around native leaflets for stabilization.
Chau discloses (see abstract; Figs. 6-9 & 23; and [0101]-[0107]) a heart valve (100) comprising a tubular frame (102), wherein the frame comprises an outflow end (112, see Fig. 6 and [0088]) and an inflow end (110, see Fig. 6 and [0088]), and further wherein at least one anchor (126) extends radially outwardly from the outflow end of the tubular braided frame and extends in a direction toward the inflow end (see Figs. 6-9 and [0101]-[0107]), the at least one anchor configured to interact with native leaflets of the heart valve (see [0101]-[0103] and Fig. 23), wherein the anchor comprises a wire configured to extend around native leaflets for stabilization (see [0101]-[0107]) in the same field of endeavor for the purpose of functioning to retain the frame within a native valve region of the heart by securing the frame to the anterior and posterior mitral leaflets such that the anchors wrap around the leaflets and extend upwards between the leaflets and the ventricular walls (see [0101]/[0103]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Schankereli’s tubular frame by providing the anchors taught by Chau in order to function to retain the frame within a native valve region of the heart by securing the frame to the anterior and posterior mitral leaflets such that the anchors wrap around the leaflets and extend upwards between the leaflets and the ventricular walls.
Claim(s) 10-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0029072 A1 to Gabbay (hereinafter “Gabbay”) (previously of record) in view of Schankereli and Chau.
Regarding claim 10, Gabbay discloses (see abstract; Figs. 1-7; and [0020]-[0071]) a device (as shown in the Figures) for assisting the functioning of a heart valve (see at least [0020]), comprising: an adapter (10) comprising a tubular adapter frame (20 + 22) that comprises an inflow end (at #20, Fig. 1) and an outflow end (at #22, Fig. 1); a flange structure (14, see Fig. 2) at the inflow end of the tubular braided adapter frame (see [0027]-[0028]).
Gabbay further discloses (claim 11) a valve assembly (12 + 16); wherein the valve assembly comprises a tubular valve-assembly frame (12) comprising a second inflow end (near #78, Fig. 2) and a second outflow end (near #80, Fig. 2); wherein the valve assembly comprises at least one commissure tab (80) at the second inflow end (see Fig. 2 and [0036]); wherein the valve assembly comprises a leaflet assembly (76/82) connected to the at least one commissure tab (see Fig. 2 and [0036]); wherein the leaflet assembly is configured to provide a seal between the second inflow end and the second outflow end (see [0036]); and (claim 12) wherein the valve assembly is configured to removably engage with the adapter, wherein the inflow end of the adapter is proximal in location to the second inflow end and the outflow end of the adapter is proximal in location to the second outflow end (see Figs. 3-5 and [0042]-[0043], capable of being removed by removing the sutures).
Gabbay fails to specifically disclose, with respect to claim 10, wherein the tubular adapter frame is braided; and at least one anchor at the outflow end of the tubular braided adapter frame, wherein the at least one anchor is made of a wire extending radially outwardly from the tubular braided adaptor frame and in a direction toward the inflow end, the at least one anchor having a fabric covering; with respect to claim 11, wherein the tubular valve-assembly frame is braided; and with respect to claim 14, wherein the tubular braided valve-assembly frame further comprises at least one braided wire wound in a helical spiral direction, wherein the helical spiral direction begins at the second inflow end and ends at the second outflow end; and wherein the at least one braided wire wound in a helical spiral direction is configured to lengthen and compress in relation to a heart contraction. Gabbay discloses that both support structures 10 and 12 are formed of a shape memory alloy such as nitinol (see [0033]), but fails to disclose that the nitinol wires are braided (Gabbay is silent as to how the nitinol is formed to construct the frame).
Schankereli discloses, in the same field of endeavor, (see abstract; Figs. 1-13; and [0077]-[0164]) a device (as shown in Figs. 1-13) for assisting the functioning of a heart valve (see at least [0077]-[0078]), comprising: an adapter (112, see Fig. 1 and [0125]-[0126]) comprising a tubular adapter frame (see [0125]-[0126]) that comprises an inflow end (near #110, Fig. 1) and an outflow end (near #114, Fig. 1); a flange structure (116) at the inflow end of the tubular braided adapter frame (see Fig. 1); and at least one anchor (114 + 138) at the outflow end of the tubular braided adapter frame (see Figs. 1/5 and [0127]/[0140]), wherein the tubular adapter frame is braided (see [0092]/[0095]) such that the frame comprises at least one braided wire wound in a helical spiral direction (see [0093]/[0095]), wherein the helical spiral direction begins at the inflow end and ends at the outflow end (see [0093]/[0095]); and wherein the tubular braided frame is configured to lengthen and compress in relation to a heart contraction (see [0092]/[0093]; [0095]/[0096]; and [0085]-[0090], the braided frame is made of the same nitinol wire as the cuff, the discussion about the cuff being able to lengthen and compress in response to heart contraction or other forces imposed on it would be understood to be equally applicable to the braided frame), and further discloses wherein the tubular braided frame is made of nitinol (see [0092]/[0095]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of use of a known technique to improve similar devices in the same way, (see KSR International Co. v. Teleflex Inc., 550 U.S. 398,82 USPQ2d 1385,1395- 97(2007)), to obtain the predictable result of a nitinol frame suitable for use in a heart valve prosthesis, by making the nitinol frame out of a braided wire material since Schankereli discloses the known technique of fabricating heart valve stents out of braided nitinol frame, and thus one of ordinary skill would have found it predictable without undue experimentation and with a reasonable expectation of success to fabricate Gabbay's frame out of braided nitinol, as taught by Schankereli, as a suitable fabrication technique to arrive at the nitinol frame contemplated by Gabbay.
Chau discloses (see abstract; Figs. 5-9 & 23; and [0101]-[0107]) a heart valve (100) comprising a tubular frame (102), wherein the frame comprises an outflow end (112, see Fig. 6 and [0088]) and an inflow end (110, see Fig. 6 and [0088]), and further wherein at least one anchor (126) extends radially outwardly from the outflow end of the tubular braided frame and extends in a direction toward the inflow end (see Figs. 6-9 and [0101]-[0107]), the at least one anchor configured to interact with native leaflets of the heart valve (see [0101]-[0103] and Fig. 23), the at least one anchor having a fabric covering (see Figs. 5 and [0108]) in the same field of endeavor for the purpose of functioning to retain the frame within a native valve region of the heart by securing the frame to the anterior and posterior mitral leaflets such that the anchors wrap around the leaflets and extend upwards between the leaflets and the ventricular walls (see [0101]/[0103]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Gabbay/Schankereli’s tubular frame by providing the anchors taught by Chau in order to function to retain the frame within a native valve region of the heart by securing the frame to the anterior and posterior mitral leaflets such that the anchors wrap around the leaflets and extend upwards between the leaflets and the ventricular walls.
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 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-37 of copending Application No. 18/694,897 (reference application) in view of Chau.
Current claim 1 finds its limitations set forth by claim 29 of ‘897 except for the anchor extending radially outwardly from the outflow end and extending in a direction toward the inflow end, the at least one anchor configured to interact with native leaflets of the heart valve. Chau discloses (see abstract; Figs. 6-9 & 23; and [0101]-[0107]) a heart valve (100) comprising a tubular frame (102), wherein the frame comprises an outflow end (112, see Fig. 6 and [0088]) and an inflow end (110, see Fig. 6 and [0088]), and further wherein at least one anchor (126) extends radially outwardly from the outflow end of the tubular braided frame and extends in a direction toward the inflow end (see Figs. 6-9 and [0101]-[0107]), the at least one anchor configured to interact with native leaflets of the heart valve (see [0101]-[0103] and Fig. 23) in the same field of endeavor for the purpose of functioning to retain the frame within a native valve region of the heart by securing the frame to the anterior and posterior mitral leaflets such that the anchors wrap around the leaflets and extend upwards between the leaflets and the ventricular walls (see [0101]/[0103]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘897 claim 1 by providing the anchors taught by Chau in order to function to retain the frame within a native valve region of the heart by securing the frame to the anterior and posterior mitral leaflets such that the anchors wrap around the leaflets and extend upwards between the leaflets and the ventricular walls.
Dependent claims 2-9 correspond to dependent claims 30-37 of the ‘897 application
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10, 13, 15-21, and 27-30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Chau is cited for teaching the amended limitation regarding the structure and function of the claimed anchor.
Applicant's arguments with respect to claims 22-26 have been fully considered but they are not persuasive. Applicant argues claim 22 in the same section as claim 1, and appears to allege that claim 22 has been amended in the same manner as claim 1 and distinguishes from Schankereli for the same reasons as claim 1. However, claim 22 does not contain any such amendment. Moreover, this is no argument as to the subject matter of claim 22 as currently constructed with respect to Schankereli. Accordingly, the rejection is maintained.
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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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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