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 .
Allowable Subject Matter
Claims 18, 22, and 27 are allowed.
Response to Arguments
Applicant's arguments filed 5/11/2026, with respect to Morin, have been fully considered but they are not persuasive. The Applicant contends that Morin does not teach sub-cell attachment members that extend into the interior space of the cell and are attached to leaflets. The examiner respectfully disagrees. Morin teaches that portions of its sub-cell attachment members are located within the cells of the frame (paras. 0056, 0059-0067); and the sub-cell attachment members are attached to the leaflets via intermediary elements, such as the cuff and the frame. In addition, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the structure and position of the sub-cell attachment members of Morin are fully capable of being connected to leaflets. In view of these recitations by the prior art references, the rejections over Dienno in view of Morin have been maintained, as described below.
Applicant’s remaining arguments with respect to claim(s) 1-11, 14-15, and 26 have been considered, but are moot in view of the new grounds of rejection. The Dienno and the Morin references have been re-interpreted, as described below, to address the claim amendments of 5/11/2026.
Claim Rejections - 35 USC § 102
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) 1-5, 8, 11, 15, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dienno et al. (WO 2016/100913 A1; hereinafter “Dienno”).
Dienno discloses the following regarding claim 1: a prosthetic valve comprising: a leaflet frame (e.g., 600, 700) (Figs. 11A-12C, 16A-19, 22-23) configured to be transitioned from a collapsed state having a first diameter to an expanded state having a second diameter that is larger than the first diameter (para. 00122), the leaflet frame having an inlet end and an outlet end (para. 0076) and defining a longitudinal axis (central axis through elements 600, 700), the leaflet frame including, a plurality of frame members (struts; e.g., 223, 225) that form a framework (e.g., Fig. 11A) defining plurality of cells (e.g., 222) each having an interior cell space (inner open space of element 222), the plurality of cells including at least one attachment cell (cells comprising elements 260), the plurality of frame members including a plurality of sub-cell attachment members (e.g., 260) extending into an interior cell space of the at least one attachment cell (e.g., Figs. 11A-11D), the sub-cell attachment members defining respective attachment locations (vertical areas where the leaflets are attached to elements 260) (e.g., Fig. 18A) along a sub-cell attachment line (please see Figure A) that is defined within a plane that is perpendicular to the longitudinal axis (e.g., Fig. 11A, where the line is in a plane perpendicular to the longitudinal axis in the sagittal direction) such that the sub-cell attachment line extends through the interior cell space of the at least one attachment cell in a direction that is perpendicular to the longitudinal axis (e.g., Fig. 11A; Figure A); and a leaflet construct (e.g., Figs. 16A-17) including a leaflet (e.g., 310) attached to one or more of the attachment locations along the sub- cell attachment line (Figs. 16B, 18A; para. 00102).
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Figure A.
Dienno discloses the following regarding claim 2: the prosthetic valve of claim 1, wherein the leaflet has a base attachment region (330), wherein the base attachment region of the leaflet is attached to one or more of the attachment locations along the sub-cell attachment line (e.g., Figs. 16B, 18A; para. 00102).
Dienno discloses the following regarding claim 3: the prosthetic valve of claim 1, wherein each of the attachment locations includes a projection base portion (lower portions of sub-cell attachment members that are directly connected to the frame) extending into the interior cell space (Figs. 11A-11B) and a projection head portion (e.g., 264) opposite the projection base portion (Figs. 11A-11B), each of the projection head portions being positioned along or adjacent the sub-cell attachment line (Figs. 11A-11B; Figure A).
Dienno discloses the following regarding claim 4: the prosthetic valve of claim 1, wherein the plurality of sub- cell attachment members includes a first sub-cell attachment member (please see annotated Figure B, below) and a second sub-cell attachment member (Figure B), and further wherein the at least one attachment cell has a top cell portion (upper half of cell) (Fig. 11A; Figure B) defined by the framework (Fig. 11A; Figure B) and a bottom cell portion (lower half of cell) (Fig. 11A; Figure B) defined by the framework (Fig. 11A; Figure B), the first sub-cell attachment member extending from the top cell portion (Figure B) and the second sub-cell attachment member extending from the bottom cell portion (Figure B).
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Figure B.
Dienno discloses the following regarding claim 5: the prosthetic valve of claim 4, wherein the first and second sub-cell attachment members are substantially parallel to each other when the leaflet frame is in the expanded state (Fig. 11A; Figure B).
Dienno discloses the following regarding claim 8: the prosthetic valve of claim 4, wherein the first sub-cell attachment member and the framework together define a shape resembling a parallelogram when the leaflet frame is in the expanded state (Fig. 11A, where the general diamond shape formed by the first sub-cell attachment member and the framework resembles a parallelogram), and wherein the second sub-cell attachment member and the framework together define a shape resembling a parallelogram when the leaflet frame is in the expanded state (Fig. 11A, where the general diamond shape formed by the second sub-cell attachment member and the framework resembles a parallelogram).
Dienno discloses the following regarding claim 11: the prosthetic valve of claim 1, wherein one of more frame members of the plurality of frame members are configured to be coupled to first and second sides of the leaflet (Figs. 18A-18B; paras. 00119-00120, 00174) one or more frame members having a first curvature when the leaflet frame is in the collapsed state (un-assembled state) (Fig. 11D) and a second curvature when the leaflet frame is in the expanded state (fully assembled expanded state) (Figs. 18A-18B), the first curvature being greater than the second curvature (Figs. 11B, 11D, 18A-18B).
Dienno discloses the following regarding claim 15: the prosthetic valve of claim 11, wherein at least two of the one or more frame members are linearly aligned with one another when the leaflet frame is in the expanded state (Figs. 11B, 18A-18B).
Dienno discloses the following regarding claim 26: the prosthetic valve of claim 1, wherein each of the sub-cell attachment members extends into the interior cell space within a plane of the at least one attachment cell (e.g., Figs. 11A-11D).
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) 6, 7, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dienno in view of Morin et al. (Pub. No.: US 2018/0055631 A1; hereinafter “Morin”).
Dienno discloses the limitations of the claimed invention, as described above. However, it does not recite the prosthetic valve comprising first, second, third, and fourth legs. Morin teaches that it is well known in the art that a top cell portion of the frame is defined by a first, upper left-side strut frame member and a second, upper right-side strut frame member (Figs. 4A, 5A-5M); a first leg extends (e.g., 461j) from the first frame member and a second leg (e.g., 460j) extends from second frame member; the first and second legs intersecting to form a first sub-cell attachment joint (e.g., Fig. 5J) defining a first attachment location; and the first one of the attachment locations intersecting with the sub-cell attachment line (when the line is extended through the attachment portions along the frame) when the leaflet frame is in the expanded state (Figs. 4A, 5A-5M; paras. 0058-0072). Morin further teaches that it is well known in the art that a bottom cell portion of the frame is defined by a third, lower left-side strut frame member and a fourth, lower right-side strut frame member (Figs. 4A, 5A-5M); a third leg extends (e.g., 461i) from the third frame member and a fourth leg (e.g., 463i) extending from fourth frame member, the third and fourth legs intersecting to form a second sub-cell attachment joint (e.g., Fig. 5I) defining a second one of the attachment locations (located on the side of the frame opposite the first attachment location), the second one of the attachment locations intersecting with the sub-cell attachment line (when the line is extended through the attachment portions along the frame) when the leaflet frame is in the expanded state at a location that is spaced apart from the first one of the attachment locations (Figs. 4A, 5A-5M; paras. 0058-0072). The legs taught by Morin provide additional structural support and attachment points for cuffs, leaflets, etc. to the prosthetic valve. Morin further teaches that the first leg of the first sub-cell attachment member is shorter than the second leg of the first sub-cell attachment member (e.g., Fig. 5G); the third leg of the second sub-cell attachment member has substantially a same length and width as the first leg of the first sub-cell attachment member (e.g., Fig. 5L); the fourth leg of the second sub- cell attachment member has substantially a same length and width as the second leg of the first sub-cell attachment member (e.g., Fig. 5L); and that the dimensions and widths of the legs can be modified to have the desired dimensions, as needed, to provide the valve with the desired dimensions and to enhance collapsibility (paras. 0080, 0087). It would have been obvious to one having ordinary skill in the art to modify the device of Dienno to comprise the legs of Morin, in order to provide the valve with the desired structural support, attachment points, and to enhance collapsibility. Such a modification would be made with a reasonable expectation of success.
In addition, regarding the width and length dimensions, the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal valve dimensions needed to achieve the desired results and ensure that the valve will properly fit its implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the valve components’ dimensions, would have been obvious at the time of applicant's invention in view of the teachings of Dienno and Morin. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dienno.
Dienno discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the values of the first and second curvatures. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal values of the first and second curvatures needed to achieve the desired results and provide the valve with the desired shape and mechanical strength. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the first and second curvatures, would have been obvious at the time of applicant's invention in view of the teachings of Dienno. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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