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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 11/12/2025 is acknowledged. Election was made without traverse in the reply filed on 11/12/2025.
Claim Objections
Claim(s) 22, 24, 30-31, 36, 39 is/are objected to because of the following informalities:
Within claims 22, 24, 30 the expanded, deployed configuration (from claim 22, line 4) is referred to as both the deployed configuration (claim 22, line 6; and claim 22, lines 7-8; and claim 30, lines 4-5) and the expanded, deployed configuration (claim 24, lines 3-4) – claim terminology is to remain consistent throughout the claims.
Within claim 30, line 4 (twice): “the frame” should be replaced with --the expandable stent frame-- (in order to maintain consistent claim terminology).
Within claim 31, lines 1-2: “the plurality of leaflets is formed” should be replaced with --the plurality of leaflets are formed--.
Within claim 36, lines 1-2: “the expandable stent” should be replaced with --the frame-- (in order to maintain consistent claim terminology).
Within claim 39, lines 1-2: “the expandable stent frame” should be replaced with --the frame-- (in order to maintain consistent claim terminology).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 25-28, 30, 32-39 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Within claim 25, lines 4-5: Applicant claims, “the frame being formed by a plurality of struts each extending continuously from the first open end to the second open end, the plurality of struts defining a plurality of cells therebetween”; Examiner can not find support within the originally filed disclosure for the frame being formed by a plurality of struts each extending continuously from the first open end to the second open end. Examiner can merely find support for the frame being formed by a plurality of wires/ strips (202) (paragraph [0082]), but the wires/ strips (202) do not EACH extend continuously between the two open ends of the frame (so there is a single wire/ strip extending between the two open ends of the frame). Instead, the frame, as disclosed by Applicant, appears to be made from a plurality of wires/ strips (202) AND vertical posts (110, 112) which surround cells (204, 206) along the entire length between the two open ends of the frame. Claim(s) 26-28, which depend from claim 25, inherit all the problems associated with claim 25.
Within claim 30, lines 3-5: Applicant claims, “the free edge of each leaflet varying along the longitudinal axis of the [expandable stent] frame when the [expandable stent] frame is in the [expanded,] deployed configuration”; Examiner can not find support within the originally filed disclosure for the aforementioned claim requirement – Examiner is unsure if Applicant is trying to claim the coaptation regions (906) having variable heights in the z-axis/ longitudinal axis (Applicant’s specifications paragraph [0105]), as seen in figs. 12B-12C.
Within claim 32, lines 1-3: Applicant claims, “the expandable stent frame is configured to be expanded to the first diameter and re-expanded to the second diameter via a catheter insertable expander”; Examiner can not find support within the originally filed disclosure for the aforementioned claim requirement specifically a SINGLE catheter insertable expander being used to BOTH expand the expandable stent frame to the first diameter AND then (at a later time) expand the expandable stent frame to the second diameter. Instead Examiner can merely find support for a FIRST expander expanding the expandable stent frame to the first diameter and in a separate procedure (and therefore likely using a second distinct) expanding the expandable stent frame to the second diameter (Applicant’s specifications paragraphs [0130-0142]), as seen in figs. 18-19. Claim(s) 33, which depend from claim 32, inherit all the problems associated with claim 32.
Within claim 34, line 7: Applicant claims, “the frame being formed by a plurality of struts defining a plurality of cells therebetween”; Examiner can not find support within the originally filed disclosure for the frame being formed by a plurality of struts. Examiner can merely find support for the frame being formed by a plurality of wires/ strips (202) (paragraph [0082]) AND vertical posts (110, 112) which surround cells (204, 206) along the entire length between the two open ends of the frame. It is unclear, if Applicant is treating “struts” within the claim as inclusive of either the plurality of wires/ strips (202) AND/OR the vertical posts. Claim(s) 35-39, which depend from claim 34, inherit all the problems associated with claim 34.
Within claim 34, lines 9-10: Applicant claims, “each leaflet from the plurality of leaflets being coupled to the frame along a leaflet attachment line, each leaflet attachment line traversing the cells while remaining within about 3mm of a strut from the plurality of struts”; Examiner can not find support within the originally filed disclosure for the aforementioned claim requirement. Instead Examiner can merely find support for the leaflet-stent attachment line can lie within about 3 mm of the frame of the stent (Applicant’s specifications paragraphs [001, 0022, 0034]); however, Examiner does not understand the aforementioned claim requirement nor specification. If the leaflet attachment line is between the leaflet and either: the plurality of wires/ strips (202) or vertical posts (110, 112) or wall (104) approximate to the frame then spacing (at least radially) therebetween would be zero.
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.
Claim(s) 22-33 is/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.
Within claim 22, lines 3-9: Applicant claims, “an expandable stent frame having a compressed, delivery configuration, in which the valve is deliverable to a patient via a catheter, and an expanded, deployed configuration, in which the valve is implantable within the patient, the valve having a first working condition when the expandable stent frame is in the deployed configuration and expanded to a first diameter and a second working condition when the expandable stent frame is in the deployed configuration and re-expanded after initial implantation and initial expansion to a second diameter that is greater than the first diameter to accommodate growth of the patient”; it is unclear, and therefore indefinite, how many expanded, deployed configurations are required of the claim – due to the “an” before the first instance of “expanded, deployed configuration” this suggests a single/ one expanded, deployed configuration; however, further within the aforementioned claim clause two different deployed configurations are claims with different diameters representing the first and second working conditions. Claim(s) 23-33, which depend from claim 22, inherit all the problems associated with claim 22.
Within claim 22, lines 13-14: Applicant claims, “the valve is expanded to the first diameter and when the valve is re-expanded to the second diameter”; it is unclear, and therefore indefinite, what has the first and second diameters – the valve as a whole (as required by the aforementioned claim requirement) OR the expandable stent frame alone (as required by claim 22, lines 4-9).
Within claim 24, lines 3-4: Applicant claims, “a diameter between about 5mm and about 30mm when in the expanded, deployed configuration”; it is unclear, and therefore indefinite, if this is the same as OR in addition to either the first diameter OR the second diameter within claim 22.
Within claim 32, line 3: Applicant claims, “a catheter insertable expander”; it is unclear, and therefore indefinite, if this is the same as OR in addition to the catheter (within claim 22, line 4).
Within claim 33, lines 1-2: Applicant claims, “wherein the expander is a balloon catheter”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the scope of the claim (which is determined by the preamble) is to the artificial growth heart valve alone; within claim 22 and 32 the artificial growth heart valve is merely CAPABLE of/ configured to being expanded by a catheter (as such Applicant is not positively claiming the catheter); however, within claim 33 it appears Applicant is trying to actually claim the balloon catheter.
Within claim 35, lines 2-4: Applicant claims, “the curved portion terminating at the linear portion and the linear portion terminating at the free edge of the leaflet”; it is unclear, and therefore indefinite, which curved portion/ linear portion/ free edge which leaflet is being referred to (as a plurality where previously claimed) – all of them? OR is this one a subset of all of them?
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.
Claim(s) 34-39 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Li et al. (US 2012/0071969 A1).
With respect to claim 34:
Li et al. discloses an artificial expandable heart valve (prosthetic heart valve 300), as can be seen in figs. 2-5 (paragraph [0042]), comprising:
an expandable stent frame (stent 302) having a compressed, delivery configuration (prior to expansion), in which the valve (prosthetic heart valve 300) is deliverable to a patient via a catheter (catheter/ delivery device), and an expanded, deployed configuration (expanded condition), in which the valve (prosthetic heart valve 300) is implantable within the patient (paragraphs [0003, 0047, 0085]); and
a plurality of leaflets (leaflets 308) disposed within and coupled to the frame (stent 302) (paragraphs [0052-0053]), each leaflet from the plurality of leaflets (leaflets 308) extending from the frame (stent 302) and terminating at a free edge (free distal end 354) (paragraph [0045]), the frame (stent 302) being formed by a plurality of struts (struts 314 and supplemental struts 726 as seen in fig. 7) defining a plurality of cells (cells 312) therebetween (paragraphs [0048, 0074, 0087]), each leaflet from the plurality of leaflets (leaflets 308) being coupled to the frame (stent 302) along a leaflet attachment line (attachment line S), each leaflet attachment line (attachment line S) traversing the cells (cells 312) while remaining within about 3 mm of a strut from the plurality of struts (struts 314 and supplemental struts 726) (a portion of the leaflets attachment line S is separated from struts 314a, 314b, 314e, and 314f by a distance of less than 2 mm, the flattened out portion of the leaflets attachment line S through cell 312a is considered by Examiner to be separated from supplemental struts 726 by about 3 mm) (paragraphs [0052-0053, 0077, 087]).
With respect to claim 35:
Wherein:
each leaflet attachment line (attachment line S) includes a curved portion (the portion of attachment line S which is near struts 314a, 314b, 314e, 314f and spans cell 312a/ is near supplemental struts 726) and a linear portion (portion of attachment line S which connects to the commissure features 316) (paragraphs [0048, 0052, 0074, 0087]), the curved portion (the portion of attachment line S which is near struts 314a, 314b, 314e, 314f and spans cell 312a/ is near supplemental struts 726) terminating at the linear portion (portion of attachment line S which connects to the commissure features 316) and the linear portion (portion of attachment line S which connects to the commissure features 316) terminating at the free edge (free distal end 354) of the leaflet (leaflets 308), each linear portion (portion of attachment line S which connects to the commissure features 316) extending parallel to a longitudinal axis of the valve (prosthetic heart valve 300) (as the stent 302 has a within the annular section has a generally cylindrical shape with a constant diameter) (paragraph [0038]).
With respect to claim 36:
Wherein the expandable stent (stent 302) includes a plurality of vertical posts (commissure features 316 and thinner posts (there are 2 shown in fig. 3) in between the commissure features 316), each linear portion (portion of attachment line S which connects to the commissure features 316) of each leaflet attachment line (attachment line S) traversing a vertical post (commissure features 316) from the plurality of vertical posts (commissure features 316 and thinner posts (there are 2 shown in fig. 3) in between the commissure features 316) (paragraph [0048]).
With respect to claim 37:
Wherein a first vertical post (commissure features 316) from the plurality of vertical posts (commissure features 316 and thinner posts (there are 2 shown in fig. 3) in between the commissure features 316) is disposed at a junction between two leaflets from the plurality of leaflets (leaflets 308), as can be seen in figs. 5, 10A.
With respect to claim 38:
Wherein the first vertical post (commissure features 316) defines a window (eyelet) covered by a polymer (cuff 306) (cuff 36 may cover all the all surfaces of the annulus section of the stent 302, inclusive of the eyelets) (paragraph [0033, 0049, 0066]), the two leaflets (leaflets 308) being cohesively coupled to the polymer (cuff 306) (the leaflets 308 maybe attached by adhesives, instead of sutures, to the cuff 306) (paragraph [0075, 0087]).
With respect to claim 39:
Wherein the expandable stent frame (stent 302) is dip-coated in a polymer (cuff 306 is made from a polymer, specifically UHMWPE, which covers all surfaces of the annulus section of the stent 302) (paragraph [0033, 0049, 0066]). (PLEASE NOTE: Claim 39 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered an expandable stent frame coated with polymer. Manufacturing steps such as dip coating are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.)
Claim(s) 22-27, 31-33 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Emani et al. (US 2017/0014228 A1).
With respect to claim 22:
Emani et al. discloses a catheter insertable (is capable of being inserted via a catheter, see note below) and re-expandable artificial growth heart valve (stented valve device 100), as can be seen in figs. 2A-2D, for implantation (paragraph [0038]), comprising:
an expandable stent frame (valve frame 130) having a compressed, delivery configuration (prior to implantation), in which the valve (stented valve device 100) is deliverable (is capable of being delivered, see note below) to a patient via a catheter, and an expanded, deployed configuration (after at least initial expansion), in which the valve (stented valve device 100) is implantable within the patient (paragraph [0031, 0073-0074, 0085-0086]), the valve (stented valve device 100) having a first working condition (partially expanded) when the expandable stent frame (valve frame 130) is in the deployed configuration (after at least initial expansion) and expanded to a first diameter (partially expanded diameter) and a second working condition (fully expanded) when the expandable stent frame (valve frame 130) is in the deployed configuration (after at least initial expansion) and re-expanded after initial implantation and initial expansion to a second diameter (fully expanded diameter) that is greater than the first diameter (partially expanded diameter) to accommodate growth of the patient (paragraph [0031, 0085-0086]); and
a plurality of leaflets (leaflets 120a-c) disposed within and coupled to the expandable stent frame (valve frame 130) (paragraphs [0048-0049]), each leaflet from the plurality of leaflets (leaflets 120a-c) extending from the expandable stent frame (valve frame 130) and terminating at a free edge, the plurality of leaflets (leaflets 120a-c) being configured to provide competent valvular function when the valve (stented valve device 100) is expanded to the first diameter (partially expanded diameter) and when the valve (stented valve device 100) is re-expanded to the second diameter (fully expanded diameter) (paragraphs [0085-0086]).
(PLEASE NOTE: With respect to claim 22: Applicant claims: artificial growth heart valve (stented valve device 100) to be catheter insertable/ deliverable to a patient via a catheter; this is functional language. “While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did no defeat the Board's finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); In Re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F. 2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). “[A]pparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).” See MPEP 2114. Examiner is considering the artificial growth heart valve (stented valve device 100), as disclosed by Emani et al., as CAPABLE of being delivered and expanded via a catheter (transcatheter balloon dilation) when the artificial growth heart valve (stented valve device 100) is being implanted within a patient that does not have such small lumens (such as: within an older child, as opposed to a small baby/ infant as disclosed by Emani et al. (paragraphs [0038-0039, 0086-0087])).
With respect to claim 23:
Wherein each free edge has a length that is greater than the first diameter (partially expanded diameter) (this is considered by Examiner to be an inherent property of the leaflets (leaflets 120a-c), as disclosed by Emani et al.; the artificial growth heart valve (stented valve device 100), as disclosed by Emani et al., is configured to be fully functional (which requires leaflet coaptation) at both the first diameter (partially expanded diameter) and the larger second diameter (fully expanded diameter); as the leaflets do not change size in the aforementioned transition the length of the free edge/ coaptation edge must be at least 2R=1D at the larger second diameter (fully expanded diameter)).
With respect to claim 24:
Wherein the expandable stent frame (valve frame 130) has a diameter (unexpanded diameter) between about 2mm and 6mm (3-7mm) when in the compressed, delivery configuration (unexpanded configuration), and a diameter (partially or fully expanded diameter) between about 5mm and about 30mm (10-22mm) when in the expanded, deployed configuration (after at least initial expansion) (paragraphs [0084-0085]).
With respect to claim 25:
Wherein: the expandable stent frame (valve frame 130) has a first open end (upstream end 102), a second open end (downstream end 104), and a longitudinal axis (longitudinal axis A) extending therebetween (paragraph [0040]), the longitudinal axis (longitudinal axis A) defining a flow path through the valve (stented valve device 100), the frame (valve frame 130) being formed by a plurality of struts (a series of longitudinal aligned struts which zigzag circumferentially on the valve frame 130 along the entire length of the valve frame 130) each [strut] (a series of longitudinal aligned struts which zigzag circumferentially on the valve frame 130 along the entire length of the valve frame 130) extending continuously from the first open end (upstream end 102) to the second open end (downstream end 104) (as can be seen in figs. 2A-2D), the plurality of struts (a series of longitudinal aligned struts which zigzag circumferentially on the valve frame 130 along the entire length of the valve frame 130) defining a plurality of cells (openings between the structure of the frame) therebetween.
With respect to claim 26:
Wherein at least a portion of the plurality of cells (openings between the structure of the frame) are covered (with membrane 140) (paragraphs [0042, 0044]).
With respect to claim 27:
Wherein at least a portion of the plurality of cells (openings between the structure of the frame) are coated with a polymer (membrane 140 is made from a polymer) (paragraph [0044-0047, 0079]).
With respect to claim 31:
Wherein the plurality of leaflets (leaflets 120a-c) are formed of a polymer (paragraph [0051]).
With respect to claim 32:
Wherein the expandable stent frame (valve frame 130) is configured to be (is capable of being) expanded to the first diameter (partially expanded diameter) and re-expanded to the second diameter (fully expanded diameter) via a catheter insertable expander (transcatheter balloon dilator) (paragraphs [0039, 0081]).
With respect to claim 33:
Wherein the expander is a balloon catheter (transcatheter balloon dilator) (paragraphs [0039, 0081]).
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.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emani et al. (US 2017/0014228 A1) in view of Li et al. (US 2012/0071969 A1).
With respect to claim 28:
Emani et al. discloses the invention substantially as claimed, as discussed above. However, Emani et al. does not disclose the expandable stent frame (valve frame 130) further defines a plurality of vertical posts, at least two of the vertical posts having different widths.
Li et al. teaches an artificial mitral expandable heart valve (prosthetic heart valve 300), as can be seen in figs. 2-5 (paragraph [0042]), comprising:
an expandable stent frame (stent 302) having a compressed, delivery configuration (prior to expansion), in which the valve (prosthetic heart valve 300) is deliverable to a patient via a catheter (catheter/ delivery device), and an expanded, deployed configuration (expanded condition), in which the valve (prosthetic heart valve 300) is implantable within the patient (paragraphs [0003, 0047, 0085]), the expandable stent frame (stent 302) includes a plurality of vertical posts (commissure features 316 and thinner posts (there are 2 shown in fig. 3) in between the commissure features 316) at least two of which have different widths (the wider commissure features 316 and thinner posts (there are 2 shown in fig. 3) in between the commissure features 316 – specifically the inclusion of wider ones at the connection point between the commissures of the leaflets and the frame); and
a plurality of leaflets (leaflets 308) disposed within and coupled to the frame (stent 302) (paragraphs [0052-0053]), each leaflet from the plurality of leaflets (leaflets 308) extending from the frame (stent 302) and terminating at a free edge (free distal end 354) (paragraph [0045]), the frame (stent 302) being formed by a plurality of struts (struts 314 and supplemental struts 726 as seen in fig. 7) defining a plurality of cells (cells 312) therebetween (paragraphs [0048, 0074, 0087]), each leaflet from the plurality of leaflets (leaflets 308) being coupled to the frame (stent 302) along a leaflet attachment line (attachment line S).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the plurality of vertical posts (commissure features 316 and thinner posts (there are 2 shown in fig. 3) in between the commissure features 316) at least two of which have different widths (the wider commissure features 316 and thinner posts (there are 2 shown in fig. 3) in between the commissure features 316), as taught by Li et al., in making the expandable stent frame (stent 302) at the points where the commissural point/ the plurality of leaflets (leaflets 120a-c) attach to the expandable stent frame (valve frame 130), as disclosed by Emani et al.. Although Emani et al. is silent concerning the specific of the expandable stent frame (valve frame 130) and plurality of leaflets (leaflets 120a-c), the increased strength/ width for eyelets in the attachment of the vertical posts (commissure features 316) and the leaflets (leaflets 308), as taught by Li et al., would be obvious to try/ beneficial as the two structures (the frames) are used for the same purpose (to support and attach prosthetic leaflets thereto) the structure of one should be interchangeable with the other.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emani et al. (US 2017/0014228 A1) in view of Dove et al. (US 2011/0238167).
With respect to claim 29:
Emani et al. discloses the invention substantially as claimed, as discussed above. Additionally, Emani et al. discloses each leaflet from the plurality of leaflets (leaflets 120a-c) has a center (middle of leaflet spaced from coapting edge and attachment edge) spaced apart from the leaflet free edge (coapting edge), as can be seen in the figures. However, Emani et al. does not disclose each free edge (coapting edge) of each leaflet having a thickness greater than a thickness of each center (middle of leaflet spaced from coapting edge and attachment edge) of each leaflet from the plurality of leaflets (leaflets 120a-c).
Dove et al. teaches an artificial heart valve comprising a plurality of leaflets (leaflets 158), as can be seen in fig. 11. Each leaflet (leaflet 158) from the plurality of leaflets has a center (center of central portion 148) spaced apart from the leaflet free edge (free edge), each free edge (free edge) of each leaflet (leaflet 158) having a thickness (thickened strip 160) greater than a thickness (small thickness) of each center of each leaflet (center of central portion 148) from the plurality of leaflets (paragraphs [0079-0082]). The increased thickness at each free edge (free edge) reduces the risk of elongation at the free edge which can result in leaflet prolapse (paragraph [0082]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the plurality of leaflets (leaflets 120a-c), as disclosed by Emani et al., with the increased thickness at the free edges thereof, as taught by Dove et al., in order to reduce the likelihood of elongation at the free edges, as taught by Dove et al..
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emani et al. (US 2017/0014228 A1) in view of Cao (US 2003/0014105 A1).
With respect to claim 30:
Emani et al. discloses the invention substantially as claimed, as discussed above. Additionally, Emani et al. does discloses the expandable stent frame (valve frame 130) has a first open end (upstream end 102), a second open end (downstream end 104), and a longitudinal axis (longitudinal axis A) extending therebetween (paragraph [0040]), the longitudinal axis (longitudinal axis A) defining a flow path through the valve (stented valve device 100). However, Emani et al. does not disclose the free edge (coapting edge) of each leaflet (leaflets 120a-c) varying along the longitudinal axis (longitudinal axis A) of the frame (valve frame 130) when the frame (valve frame 130) is in the deployed configuration (after at least initial expansion).
Cao teaches an artificial heart valve comprising a plurality of leaflets (leaflets 31), as can be seen in fig. 1. wherein the free edge (free edge 35), as can be seen in figs. 13A-13B, of each leaflet (leaflet 31) varying (having a variable height due to the curvature of the free edge 35) along the longitudinal axis of the frame (made up of insert member 51, clip 53, and support structure 39) when the artificial heart valve is implanted; the varying (having a variable height due to the curvature of the free edge 35) of the leaflet (leaflet 31) along the longitudinal axis of the frame (made up of insert member 51, clip 53, and support structure 39) allows for reduced stress in areas of high stress (around the commissural attachment points) within the leaflets (leaflets 31) (paragraph [0048]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the plurality of leaflets (leaflets 120a-c), as disclosed by Emani et al., the varying (having a variable height due to the curvature of the free edge 35) of the leaflet (leaflet 31) along the longitudinal axis of the frame (made up of insert member 51, clip 53, and support structure 39), as taught by Cao, in order to reduced stress in areas of high stress (around the commissural attachment points) within the leaflets, as taught by Cao.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Justino (US 2005/0137682 A1) discloses a heart valve where the free edge/ coaptation edge is equal to the D of the expanded stent frame.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REBECCA S PRESTON/ Examiner, Art Unit 3774