CTNF 18/157,044 CTNF 82615 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 without traverse of Species G in the reply filed on 5/11/2026 is acknowledged. The requirement is deemed proper and is therefore made FINAL. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1-6, 8-13, 15, and 17-20 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Levi et al. (WO 2012/048035 A2; hereinafter “Levi”) . Levi discloses the following regarding claim 1: an implantable prosthetic device, comprising: a frame (e.g., 12, 50) movable between a radially compressed configuration and a radially expanded configuration (paras. 0052, 0061-0062), the frame having an inflow orifice (lower opening), an outflow orifice (upper opening), and comprising one or more commissure windows (e.g., 20, 62); a valvular structure (14) comprising a plurality of leaflets (40), each leaflet comprising a main body (e.g., Fig. 21) having an inflow edge (108), an outflow edge (110), and a pair of opposing tabs (112 and/or 116) extending from opposite sides of the main body (e.g., Fig. 21), each tab being paired with an adjacent tab of an adjacent leaflet to form a commissure tab assembly (e.g., Figs. 24, 31-35; paras. 0079-0081), each commissure tab assembly being coupled to a respective commissure window (e.g., Figs. 31-35; paras. 0079-0082); and wherein each tab extends from the main body at an angle such that a radially outer edge of the tab corresponds to a draft angle of the frame (e.g., Fig. 32; where the assembled tab’s outer edge and the frame have the same angle of taper). Levi discloses the following regarding claim 2: the prosthetic device of claim 1, wherein an outflow edge (upper edge of the tab) of each tab is spaced apart from the outflow edge (upper edge near element 118) of the leaflet by a stepped portion (e.g., Fig. 21). Levi discloses the following regarding claim 3: the prosthetic device of claim 1, wherein the tabs have a height selected such that the commissure tab assembly fits within a respective commissure window without forming a radially-extending rigid portion (via element 124) (Figs. 31-35; paras. 0075-0076). Levi discloses the following regarding claim 4: the prosthetic device of claim 1, wherein each tab has a height that substantially corresponds with a height of the commissure window (e.g., Figs. 30-35, 37). Levi discloses the following regarding claim 5: the prosthetic device of claim 1, wherein an outflow edge (upper edge of tab) of the tab is disposed at a 90 degree angle relative to a longitudinal axis of the leaflet (upon assembly) (Figs. 32-33). Levi discloses the following regarding claim 6: the prosthetic device of claim 1, wherein each tab is a lower tab (116) and wherein each leaflet further comprises a pair of upper tabs (112) extending from the main body and coupled to the main body via a neck portion (please see annotated Figure A, below), each upper tab comprising a radially inner edge (Figure A), a radially outer edge (Figure A), and a free edge (Figure A). PNG media_image1.png 313 491 media_image1.png Greyscale Figure A. Levi discloses the following regarding claim 8: the prosthetic device of claim 6, wherein the radially inner edge of each upper tab tapers toward a free edge of the upper tab (e.g., Fig. 21; Figure A). Levi discloses the following regarding claim 9: the prosthetic device of claim 6, wherein the upper tabs and neck portions of each leaflet are formed integrally with the main body of the respective leaflet (e.g., Fig. 21). Levi discloses the following regarding claim 10: the prosthetic device of claim 6, wherein each upper tab is folded along the neck portion toward the inflow edge of the leaflet to form a rigid portion that extends radially inwardly toward a longitudinal axis of the frame (paras. 0079-0081, 0091). Levi discloses the following regarding claim 11: the prosthetic device of claim 6, wherein a width of the neck portion is selected to provide a selected geometric orifice area (GOA) of the outflow orifice (Fig. 25; paras. 0051). Levi discloses the following regarding claim 12: an implantable prosthetic device, comprising: a cylindrical frame (e.g., 12, 50) movable between a radially compressed configuration and a radially expanded configuration (paras. 0052, 0061-0062); a valvular structure (14) comprising a plurality of leaflets (40), each leaflet comprising a main body (e.g., Fig. 21) having an inflow edge (108), an outflow edge (110), and a pair of opposing tabs (112 and/or 116) extending from opposite sides of the main body (e.g., Fig. 21); and wherein each tab extends from the main body such that an outflow edge (upper edge of tab) of the tab is disposed at a 90-degree angle relative to a longitudinal axis of the leaflet (upon assembly of the device) (e.g., Figs. 32-33, 37). Levi discloses the following regarding claim 13: the prosthetic device of claim 12, wherein an outflow edge (upper edge of tab) of each tab is spaced apart from the outflow edge (upper edge near element 118) of the leaflet by a stepped portion (e.g., Fig. 21). Levi discloses the following regarding claim 15: the prosthetic device of claim 12, wherein the tabs are lower tabs (116) and wherein each leaflet further comprises opposing upper tabs (112) coupled the outflow edge of the leaflet via a neck portion (Figure A), wherein each lower tab is paired with an adjacent lower tab of an adjacent leaflet to form a commissure (e.g. Figs. 31-35; paras. 0079-0082), and wherein each upper tab is folded toward an inflow end of the frame such that the neck portion forms a rigid portion extending radially inwardly toward a longitudinal axis of the frame (paras. 0079-0081, 0091). Levi discloses the following regarding claim 17: the prosthetic device of claim 16, wherein the radially inner edge of each upper tab tapers toward a free edge of the upper tab (Figure A; e.g., Fig. 21). Levi discloses the following regarding claim 18: the prosthetic device of claim 15, wherein the upper tabs and neck portions of each leaflet are formed integrally with the main body of the respective leaflet (Figure A; e.g., Fig. 21). Levi discloses the following regarding claim 19: the prosthetic device of claim 15, wherein each upper tab is folded along the neck portion toward the inflow edge of the leaflet to form a rigid portion that extends radially inwardly toward a longitudinal axis of the frame (paras. 0079-0081, 0091). Levi discloses the following regarding claim 20: the prosthetic device of claim 15, wherein a width of the neck portion is selected to provide a selected geometric orifice area (GOA) of the outflow orifice (e.g., Fig. 25; para. 0025) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 7, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi . Levi discloses the limitations of the claimed invention, as described above. It further recites the frame comprising one or more commissure openings (e.g., 20, 62). However, it does not explicitly recite the neck portion having a first width that is less than half of a second width of the lower tab; and each tab having a height 0.1 mm greater than a height of the commissure opening. 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 leaflet dimensions needed to achieve the desired results and properly fit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the dimensions of the leaflets, would have been obvious at the time of applicant's invention in view of the teachings of Levi. 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 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ANN HU/Primary Examiner, Art Unit 3774 Application/Control Number: 18/157,044 Page 2 Art Unit: 3774 Application/Control Number: 18/157,044 Page 3 Art Unit: 3774 Application/Control Number: 18/157,044 Page 4 Art Unit: 3774 Application/Control Number: 18/157,044 Page 5 Art Unit: 3774 Application/Control Number: 18/157,044 Page 6 Art Unit: 3774 Application/Control Number: 18/157,044 Page 7 Art Unit: 3774
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