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 .
Priority
This application is a continuation of United States Patent Application Serial No. 18/207,822, filed June 9, 2023, now U.S. Patent No. 12,201,522, which is a continuation of United States Patent Application Serial No. 17/114,251, filed December 7, 2020, now U.S. Patent No. 11,717,400, which is a continuation of United States Patent Application Serial No. 15/995,528, filed June 1, 2018, now U.S. Patent No. 10,869,759, which claims the benefit of United States Provisional Application Serial No. 62/515,437, filed June 5, 2017.
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.
Claim(s) 1-2, 16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge et al. (US 2013/0046373, hereinafter “Cartledge”).
Referring to claim 1, Cartledge discloses a mechanically expandable prosthetic heart valve frame assembly (FIGS. 64-65, FIG. 64 is reproduced below; paras. [0219]-[0225]), comprising: a first set of a plurality of first struts and a second set of a plurality of second struts; wherein the first struts are pivotally connected with the second struts to form a first annular frame structure 6410 that is radially compressible and expandable; and a valve member 6440 (para. [0225]) comprising a plurality of leaflets (FIG. 64 shows valve assembly has three leaflets) mounted to at least the first annular frame structure of the annular frame assembly.
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Referring again to claim 1, the embodiment as shown in FIGS. 64-65 fails to discloses a third set of a plurality of third struts and a fourth set of a plurality of fourth struts; wherein the third struts are pivotally connected with the fourth struts to form a second annular frame structure that is radially compressible and expandable; wherein the first annular frame structure is positioned within and pivotally connected to the second annular frame structure to form an annular frame assembly that is radially compressible and expandable; and wherein the annular frame assembly is configured such that rotation of the first and second sets of struts relative to the third and fourth sets of struts permits radial expansion of the annular frame assembly.
Referring still to claim 1, however, Cartledge discloses other stent lattices can be used in replacement heart valves ([0218]: “The exemplary actively controllable stent lattices of the invention can be used in devices and methods in which prior art self-expanding stents have been used. In addition to the example of a proximal stent shown in the exemplary stent graft of FIGS. 38 to 41, the technology described herein and shown in the instant stent delivery systems and methods for delivering such devices can be use in any stent graft or implant, such as those used in abdominal or thoracic aneurysm repair. Additionally, the exemplary stent lattices of the invention can be used in replacement heart valves, for example.”). Attention is directed to the stent lattices as shown in FIGS. 54-62. FIG. 55 is reproduced and annotated below. The stent lattice as shown in FIG. 55 shows a third set of a plurality of third struts and a fourth set of a plurality of fourth struts; wherein the third struts are pivotally connected with the fourth struts to form a second annular frame structure that is radially compressible and expandable; wherein the first annular frame structure is positioned within and pivotally connected to the second annular frame structure to form an annular frame assembly that is radially compressible and expandable; and wherein the annular frame assembly is configured such that rotation of the first and second sets of struts relative to the third and fourth sets of struts permits radial expansion of the annular frame assembly. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have substitute the stent lattice of the heart valve assembly as shown in FIGS. 64-65 with the stent lattice as shown in FIG. 55 since Cartledge suggests other stent lattice can be used in the heart valve assembly.
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Referring to claim 2, Cartledge discloses the mechanically expandable prosthetic heart valve frame assembly of claim 1, wherein: each first strut is pivotally connected to a plurality of the second struts via a plurality of projections and respective apertures, and each third strut is pivotally connected to a plurality of the fourth struts via a plurality of projections and respective apertures (annotated figure above shows one of the first struts connected to two of the second struts and one of the third struts connected to two of the fourth struts; “Each of the crossing points of the interior and exterior sub-lattices is connected via fasteners (e.g., rivets, screws, and the like). The outer ends of the struts, however, are not directly connected and, instead, are connected by intermediate hinge plates having two throughbores through which a fastener connects respectively to each of the adjacent strut ends.” (para. [0217])).
Referring to claim 16, Cartledge discloses a mechanically expandable prosthetic heart valve frame assembly (FIGS. 64-65, FIG. 64 is reproduced below; paras. [0219]-[0225]), comprising: a first set of a plurality of first struts and a second set of a plurality of second struts ; wherein the first struts are pivotally connected with the second struts to form a first annular frame structure 6410 (FIG. 64, which is reproduced above) that is radially compressible and expandable; and a valve member 6440 (FIG. 64; para. [0225]) comprising a plurality of leaflets (FIG. 64 shows valve assembly has three leaflets) mounted to the annular frame assembly.
Referring again to claim 16, the embodiment as shown in FIGS. 64-65 fails to discloses a third set of a plurality of third struts and a fourth set of a plurality of fourth struts; wherein the third struts are pivotally connected with the fourth struts to form a second annular frame structure that is radially compressible and expandable; and wherein the first annular frame structure is positioned within and pivotally connected to the second annular frame structure to form an annular frame assembly; and one or more hinges or projections that extend between the first and second annular frame structures to pivotally connect the first and second annular frame structures; and wherein the annular frame assembly is configured to be opened or closed by pivoting about the one or more hinges or projections to rotate the first and second sets of struts relative to the third and fourth sets of struts.
Referring still to claim 16, however, Cartledge discloses other stent lattices can be used in replacement heart valves ([0218]: “The exemplary actively controllable stent lattices of the invention can be used in devices and methods in which prior art self-expanding stents have been used. In addition to the example of a proximal stent shown in the exemplary stent graft of FIGS. 38 to 41, the technology described herein and shown in the instant stent delivery systems and methods for delivering such devices can be use in any stent graft or implant, such as those used in abdominal or thoracic aneurysm repair. Additionally, the exemplary stent lattices of the invention can be used in replacement heart valves, for example.”). Attention is directed to the stent lattices as shown in FIGS. 54-62. FIG. 55 is reproduced and annotated above. The stent lattice as shown in FIG. 55 shows a third set of a plurality of third struts and a fourth set of a plurality of fourth struts; wherein the third struts are pivotally connected with the fourth struts to form a second annular frame structure that is radially compressible and expandable; and wherein the first annular frame structure is positioned within and pivotally connected to the second annular frame structure to form an annular frame assembly; and one or more hinges or projections that extend between the first and second annular frame structures to pivotally connect the first and second annular frame structures (a portion of paragraph [0217] is reproduced below); and wherein the annular frame assembly is configured to be opened or closed by pivoting about the one or more hinges or projections to rotate the first and second sets of struts relative to the third and fourth sets of struts (annotated figure above shows one of the first struts connected to two of the second struts and one of the third struts connected to two of fourth struts; “Each of the crossing points of the interior and exterior sub-lattices is connected via fasteners (e.g., rivets, screws, and the like). The outer ends of the struts, however, are not directly connected and, instead, are connected by intermediate hinge plates having two throughbores through which a fastener connects respectively to each of the adjacent strut ends.” (para. [0217])). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have substitute the stent lattice of the heart valve assembly as shown in FIGS. 64-65 with the stent lattice as shown in FIG. 55 since Cartledge suggests other stent lattice can be used in the heart valve assembly.
Referring to claim 20, Cartledge discloses a mechanically expandable prosthetic heart valve frame assembly, comprising: a first set of a plurality of first struts and a second set of a plurality of second struts; wherein the first struts are pivotally connected with the second struts to form a first annular frame structure 6410 (FIG. 64, which is reproduced above) that is radially compressible and expandable; a valve member 6440 (FIG. 64; para. [0225]) comprising a plurality of leaflets (FIG. 64 shows valve assembly has three leaflets) mounted to at least the first annular frame structure; and one or more actuators 6430 (jack assemblies 6430 as disclosed in paragraph [0321]) mounted to the first annular frame structure; and wherein the one or more actuators are configured to radially expand the annular frame assembly by rotating the first and second sets of struts relative to the second set of struts.
Referring again to claim 20, the embodiment as shown in FIGS. 64-65 fails to discloses a third set of a plurality of third struts and a fourth set of a plurality of fourth struts; wherein the third struts are pivotally connected with the fourth struts to form a second annular frame structure that is radially compressible and expandable; and wherein the first annular frame structure is positioned within and pivotally connected to the second annular frame structure to form an annular frame assembly.
Referring still to claim 20, however, Cartledge discloses other stent lattices can be used in replacement heart valves ([0218]: “The exemplary actively controllable stent lattices of the invention can be used in devices and methods in which prior art self-expanding stents have been used. In addition to the example of a proximal stent shown in the exemplary stent graft of FIGS. 38 to 41, the technology described herein and shown in the instant stent delivery systems and methods for delivering such devices can be use in any stent graft or implant, such as those used in abdominal or thoracic aneurysm repair. Additionally, the exemplary stent lattices of the invention can be used in replacement heart valves, for example.”). Attention is directed to the stent lattices as shown in FIGS. 54-62. FIG. 55 is reproduced and annotated above. The stent lattice as shown in FIG. 55 shows a third set of a plurality of third struts and a fourth set of a plurality of fourth struts; wherein the third struts are pivotally connected with the fourth struts to form a second annular frame structure that is radially compressible and expandable; and wherein the first annular frame structure is positioned within and pivotally connected to the second annular frame structure to form an annular frame assembly; and the one or more actuators are configured to radially expand the annular frame assembly by rotating the first and second sets of struts relative to the third and fourth sets of struts (annotated figure above shows one of the first struts connected to two second struts and one of third strut connected to two of fourth struts; Cartledge also discloses “Each of the crossing points of the interior and exterior sub-lattices is connected via fasteners (e.g., rivets, screws, and the like). The outer ends of the struts, however, are not directly connected and, instead, are connected by intermediate hinge plates having two throughbores through which a fastener connects respectively to each of the adjacent strut ends.” (para. [0217])). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have substitute the stent lattice of the heart valve assembly as shown in FIGS. 64-65 with the stent lattice as shown in FIG. 55 since Cartledge suggests other stent lattice can be used in the heart valve assembly. Examiner notes that one of ordinary skill in the art will appreciate that the one or more actuators 6430 would couple to the nodes of the inner/first annular frame structure of the embodiment as shown in FIG. 55 to radially expand the annular frame assembly by rotating the first and second sets of struts relative to the third and fourth sets of struts
Claim(s) 5-7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge et al. in view of Levi et al.(US 2015/0320556, hereinafter “Levi”).
Referring to claim 5, Cartledge discloses the valve member is mounted inside the first annular frame structure (FIGS. 64-65 show the valve member 6440 is mounted inside the frame structure, thus, the one of ordinary skill in the art would appreciate that when substitute the frame structure 6410 with the frame structure as shown in FIGS. 55-56, the valve member 6440 also mounted inside the frame structure of the embodiment as shown in FIGS. 55-56). Cartledge discloses the invention substantially as claimed except for disclosing a skirt mounted to the first annular frame structure and/or the second annular frame structure.
Referring again to claim 5, however, in the same field of endeavor, which is a mechanically expandable prosthetic heart valve assembly, Levi discloses the expandable prosthetic heart valve assembly includes a skirt, wherein the skirt includes an inner skirt 16 and an outer skirt 18, which is attached to the inner skirt 16 at lower edge 160 (FIGS. 1-3 and 42; para. [0074]). The inner skirt 16 coupled to an inner surface of the expandable frame structure and the outer skirt 18 coupled to an outer surface of the expandable frame structure. Levi further discloses the outer skirt 18 is made from a self-expandable fabric comprising fibers made of shape memory material having a shape memory set to enhance the radially outward buckling of the slack of the outer skirt to prevent leakage between the valve assembly and the annulus (paras. [0006]-[0007]). In view of Levi’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have provided skirts 16 and 18 to the valve assembly of Cartledge to prevent leakage between the valve assembly and the annulus.
Referring to claim 6, Cartledge discloses the mechanically expandable prosthetic heart valve frame assembly of claim 1 and the valve assembly includes three leaflets (see FIG. 64 above). Cartledge discloses the invention substantially as claimed except for disclosing wherein each leaflet of the plurality of leaflets is formed with commissure tabs on opposite sides of the leaflet.
Referring again to claim 6, however, in the same field of endeavor, which is a mechanically expandable prosthetic heart valve assembly, Levi discloses valve assembly includes three leaflets and each leaflet of the leaflets is formed with commissure tabs on opposite sides of the leaflet to facilitate the forming of the leaflet assembly (FIG. 25) and the attachment of leaflet assembly to the expandable frame. Levi further discloses the advantage of the design of the commissure tabs is to relieve some of the pressure on the commissures caused by the balloon, reducing potential damage to the commissures during expansion (FIGS. 22-26 and 30-33; paras. [0065] and [0070]-[0072]). In view of Levi’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified leaflets of Cartledge to include commissure tabs as suggested by Levi to facilitate the forming of the leaflet assembly, the attachment of the leaflet assembly to the expandable frame and to reducing potential damage to the commissures during expansion.
Referring to claim 7, Cartledge/Levi discloses the mechanically expandable prosthetic heart valve frame assembly of claim 6, wherein the plurality of leaflets comprises at least a first leaflet and a second leaflet, and further wherein a first commissure tab of the first leaflet is connected with a second commissure tab of the second leaflet (FIG. 25 of Levi reference is reproduced below).
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Referring to claim 9, Cartledge/Levi discloses the mechanically expandable prosthetic heart valve frame assembly of claim 1, further comprising a skirt mounted to both the first annular frame structure and the second annular frame structure (see rejection of claim 5 above).
Allowable Subject Matter
Claims 3-4, 8, 10-15 and 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771