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 Status
Applicant’s Remarks and Amendments filed 26 May 2026 have been entered. Claims 1-21 are canceled. Claims 22-41 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 22-41 have been considered but are moot because the new ground of rejection does not rely on any interpretation of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 refers to a “second part” comprising a “shape memory structure” that is unclear in its definition. Examiner is unclear as to whether a “shape memory structure” means the second part comprises a shape memory material, which is separately stated in the specification, or whether the second part merely exhibits certain characteristics that are similar to a shape memory material. Further clarification is required. Claims 23-31 are rejected by dependency.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 22, 24-29, 31-35, and 37-41 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Chau et al. (US 2015/0230919 A1), “Chau”.
Regarding claim 22, Chau teaches
An apparatus for use with a valve of a heart of a subject, the valve having a first leaflet and a second leaflet (Fig. 19, anterior leaflet and posterior leaflet 8), and
the apparatus comprising a leaflet support (Fig. 19, prosthetic device 600) having:
a first part, configured for placement upstream of the first leaflet (Fig. 19, body 602), and
a second part: fixed to the first part, implantable at a site behind a downstream surface of the first leaflet (Fig. 19, stiffening member 610), and
comprising a shape-memory structure (Fig. 19, stiffening member 610 comprises a nitinol band [0122]) that is configured to self-expand while disposed behind the downstream surface of the first leaflet to anchor the leaflet support at the valve and push the first leaflet toward the second leaflet (Fig. 19, prosthetic device 600 treats mitral regurgitation and promotes a better seal with the opposing leaflet by increasing the stiffness of the device [0123]).
Regarding claim 24, Chau teaches
wherein the site is in a subannular groove of the valve (Fig. 19, prosthetic device 600 is positioned at the subannular surface of the heart leaflet [0122]).
Regarding claim 25, Chau teaches
wherein the second part is configured to be placed behind chordae tendineae that are connected to the first leaflet (Fig. 19, stiffening member 610 is positioned behind leaflet 8).
Regarding claim 26, Chau teaches
wherein the first part comprises a coaptation element having a first leaflet-contacting surface configured to face the first leaflet (Fig. 19, body 602 comprises first end and second end portions 604, 606 which further comprise an upper surface which contacts opposite leaflet) and
a second leaflet-contacting surface configured to face the second leaflet (Fig. 19, body 602 first end and second end portions 604, 606 which further comprise underside surfaces which contact leaflet 8).
Regarding claim 27, Chau teaches
wherein the second part is configured to support the coaptation element between the first leaflet and the second leaflet such that, during systole of the heart, the second leaflet coapts with the coaptation element (Fig. 19, stiffening member 610 is coupled to suture 608 and further to body 602 to promote a better seal with the opposing leaflet [0122-0124]).
Regarding claim 28, Chau teaches
wherein the coaptation element is configured to extend from a first commissure of the valve to a second commissure of the valve (a single prosthetic device (prosthetic device 600) may extend across one of the commissures of the mitral valve such that it is implanted at least partially on both leaflets [0199]).
Regarding claim 29, Chau teaches
wherein the leaflet support comprises a flexible frame (Fig. 19, prosthetic device 600 comprises suture of tether 608), and
the coaptation element is fixed upon the flexible frame (Fig. 19, first and second end portions 604, 606 of body 602 are secured to leaflet with tether 608 [0121]).
Regarding claim 31, Chau teaches
wherein the flexible frame is biased to maintain the first leaflet-contacting surface in contact with the first leaflet while the second part is implanted at the site (Fig. 18F, suture 106 can have its tension adjusted to position first end portion 108 against ventricular side of leaflet 8 [0096] (prosthetic device is implanted by steps of Figs. 18A-F [0123])).
Regarding claim 32, Chau teaches
An apparatus for use with a valve of a heart of a subject, the valve having a first leaflet and a second leaflet (Fig. 19, anterior leaflet and posterior leaflet 8), and
the apparatus comprising a leaflet support (Fig. 19, prosthetic device 600) having:
a leaflet-contacting surface (Fig. 19, regions of prosthetic device 600 which contact native valve leaflets), and
a shape-memory structure: implantable at a site behind a downstream surface of the first leaflet (Fig. 19, stiffening member 610 comprises a nitinol band [0122]), and
configured to self-expand while disposed behind the downstream surface of the first leaflet to anchor the leaflet support at the valve and press the leaflet-contacting surface against the first leaflet (Fig. 19, prosthetic device 600 treats mitral regurgitation and promotes a better seal with the opposing leaflet by increasing the stiffness of the device [0123]).
Regarding claim 33, Chau teaches
wherein the shape-memory structure (Fig. 19, stiffening member 610 comprises a nitinol band [0122]) is configured to self-expand while disposed behind the downstream surface of the first leaflet to push the first leaflet toward the second leaflet (Fig. 19, prosthetic device 600 treats mitral regurgitation and promotes a better seal with the opposing leaflet by increasing the stiffness of the device [0123]).
Regarding claim 34, Chau teaches
wherein the site is between chordae tendineae of the heart (device can be centered between chordae tendons below the mitral valve [0083]).
Regarding claim 35, Chau teaches
wherein the leaflet support further comprises a coaptation element that defines the leaflet-contacting surface (Fig. 19, body 602 comprises first end and second end portions 604, 606 which contact the leaflet surfaces).
Regarding claim 37, Chau teaches
wherein the coaptation element is configured to extend from a first commissure of the valve to a second commissure of the valve (a single prosthetic device (prosthetic device 600) may extend across one of the commissures of the mitral valve such that it is implanted at least partially on both leaflets [0199]).
Regarding claim 38, Chau teaches
wherein the coaptation element further defines a second leaflet-contacting surface configured to face the second leaflet (Fig. 19, body 602 first end and second end portions 604, 606 which further comprise underside surfaces which contact leaflet 8).
Regarding claim 39, Chau teaches
wherein the shape-memory structure is configured to support the coaptation element between the first leaflet and the second leaflet such that, during systole of the heart, the second leaflet coapts with the second leaflet-contacting surface (Fig. 19, stiffening member 610 is coupled to suture 608 and further to body 602 to promote a better seal with the opposing leaflet [0122-0124]).
Regarding claim 40, Chau teaches
wherein the leaflet-contacting surface comprises a fabric configured to encourage growth of tissue of the first leaflet into the leaflet-contacting surface (Fig. 19, body 102 comprises polyethylene terephthalate (PET) [0084]).
Regarding claim 41, Chau teaches
wherein the fabric comprises a polyester fabric (Fig. 19, body 102 comprises polyethylene terephthalate (PET) [0084]).
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 23 is rejected under 35 U.S.C. 103 as being unpatentable over Chau et al. (US 2015/0230919 A1), “Chau” in view of Padala et al (US 2020/0205978 A1), “Padala”.
Regarding claim 23, Chau teaches the second part disposed behind the downstream surface of the first leaflet (Fig. 19, stiffening member 610), but fails to teach an absorbent material configured to passively fill with blood.
Padala teaches a cardiac valve leaflet enhancing device comprising an absorbent material configured to passively fill with blood (Fig. 5A, covering members 500 include layers of material configured to absorb blood [0163]). Padala discloses that that material layers are expandable after implantation through blood absorption to enhance attachment or compression of the native leaflet between the first and second sections of the device [0163]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the second part taught by Chau with the absorbent material taught by Padala in order to better attach the device to the native valve leaflets.
Claims 30 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Chau et al. (US 2015/0230919 A1), “Chau” in view of Khairhahan et al. (US 2013/0023985 A1), “Khaikhahan”.
Regarding claim 30, Chau teaches the flexible frame (Fig. 19, prosthetic device 600 comprises suture of tether 608), but fails to teach wherein the flexible frame is elastically deformable.
Khairkhahan teaches a device for mitral valve regurgitation comprising a flexible frame that is elastically deformable (Fig. 8A, struts 830 comprise resiliently deformable materials such as nitinol [0100]). Khairkhahan discloses that the struts may be shaped in any number of ways to assist in maintaining the desired shape and curvature of the implant [0109]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the elastically deformable material taught by Khairkhahan with the frame taught by Chau in order to maintain the shape of the device so that it best fits within the valve.
Regarding claim 36, Chau teaches the leaflet-contacting surface (Fig. 19, regions of prosthetic device 600 which contact native valve leaflets), but fails to teach wherein the leaflet-contacting surface comprises an integrin-binding ligand.
Khairkhahan teaches a device for mitral valve regurgitation comprising an integrin-binding ligand (Fig. 8B, valve body covering 850 comprises acellular collagen matrix [0100]). Khairkhahan discloses that the valve body covering enhances the capability of the implant to be folded small enough for delivery using a catheter [0100]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the integrin-binding ligand taught by Khairkhahan with the leaflet-contacting surface taught by Chau in order to simplify bodily delivery of the device.
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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/G.G.R./ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
