CTNF 18/522,551 CTNF 88243 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. Detailed Action This is in response to the non-provisional application filed 11/29/2023. Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 14, 16, 17 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. 12-151-07 AIA 07-97 12-51-07 Claim s 18-20 are allowed. The following is a statement of reasons for the indication of allowable subject matter claim 14 recites the frame further comprising a plurality of axially extending posts, wherein each of the posts comprises an indentation configured to receive the midsection of an adjacent selected strut when the frame is in a radially compressed state. Claim 16 recites the frame further comprising a plurality of axially extending first posts and a plurality of axially extending second posts, wherein selected pairs of axially aligned first and second posts form a first set of selected posts and other selected pairs of axially aligned first and second posts form a second set of selected posts; wherein the frame further comprises: a first set of nuts coupled to the second posts of the first set of selected posts and a second set of nuts coupled to the second posts of the second set of selected posts, wherein the first set of nuts differ in at least one dimension from the second set of nuts; and a plurality of first actuator members extending through the first set of selected posts and the first set of nuts, and a plurality of second actuator members extending through the second set of selected posts and the second set of nuts, wherein the first actuator members are configured to rotate in a first direction and the second actuator members are configured to rotate in a second direction, the first and second actuator members being configured to radially expand the frame from a radially compressed state to a radially expanded state. Claim 17 recites the frame further comprising a plurality of axially extending posts, at least one post comprising an inner bore extending therethrough and an aperture extending from an external surface of the frame to the inner bore of the post. Claim 18 recites each commissure tab is paired with a commissure tab of an adjacent leaflet to form a plurality of commissures coupled to respective commissure support portions of the frame and having inflow ends and outflow ends, wherein the leaflets are tensioned across the outflow edges of the leaflets when the leaflets are in the opened state. The office agrees the art of record fails to teach or suggest these features. 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. 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 1-4, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0361419 (Morin et al.) Regarding claims 1-4, 7 Morin et al. discloses as shown in Figure 5b a prosthetic heart valve comprising: a radially expandable and compressible frame (stent 12, see paragraph [0022]) comprising an outflow end portion (generally indicated as A), an inflow end portion (generally indicated as B) having a plurality of inflow apices (generally indicated as C), and a cantilevered axial extension (arm 372, see paragraph [0041]), each axial extension having a fixed end and free end disposed between a pair of adjacent inflow apices; and a plurality of valve leaflets (leaflets 60, see paragraph [0033]) disposed within and coupled to the frame, each leaflet comprising a main body having an outflow edge portion and an inflow edge portion coupled to a respective axial extension; wherein the leaflet inflow edge portions are secured to the free end of the axial extension, wherein the leaflet inflow edge portions and the free ends of the axial extension is capable of moving radially inwardly (if manipulated by hand) when the leaflets close under the back flow of blood and radially outwardly when the leaflets open under the forward flow of blood, wherein the leaflet inflow edge portions and the free end of the axial extension is capable of moving laterally (if manipulated by hand) toward adjacent inflow apices when a force is applied to the axial extension, the frame further comprising a central longitudinal axis extending from the inflow end portion to the outflow end portion, wherein the axial extension is capable of resisting radial movement toward the longitudinal axis of the frame when the leaflets close under the back flow of blood and away from the longitudinal axis when the leaflets open under the forward flow of blood, wherein the free end of the axial extension is capable of compressing in a circumferential direction of the frame when the frame is radially compressed. PNG media_image1.png 480 622 media_image1.png Greyscale Morin fails to disclose a plurality of cantilevered axial extensions. It would have been obvious to one or ordinary skill in the art to modify the prosthetic heart valve disclosed by Morin such that there were a plurality of cantilevered axial extensions (arms 372 at the other inflow apices marked as C) because it would only require a duplication of parts with out producing a new and unexpected result. See In re Harza , 274 F.2d 669, 124 USPQ 378 (CCPA 1960) . 07-21-aia AIA Claim (s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0361419 (Morin et al.) in view of U.S. Patent Publication Number 2018/0055631 (Morin et al. ‘631) Regarding claim 5, Morin fails to disclose the frame further comprising an outer skirt mounted to an outer surface of the frame, the outer skirt coupled to one or more axial extensions. Morin et al. ‘631,from the same field of endeavor teaches a similar prosthetic heart valve as shown in Figure 4A wherein the frame further comprising an outer skirt mounted to an outer surface of the frame, the outer skirt coupled to one or more axial extensions for the purpose of facilitating seal between the valve and the chamber of the heart it is disposed in. See paragraphs [0055], [0056]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve disclosed by Morin to include an outer skirt mounted to an outer surface of the frame, the outer skirt coupled to one or more axial extensions in order to facilitate sealing between the outer surface of the frame and the chamber of the heart it is disposed, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143 . 07-21-aia AIA Claim (s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0361419 (Morin et al.) in view of U.S. Patent Publication Number 2012/0078347 (Bradio et al.) Regarding claim 6, Morin fails to disclose wherein the free ends of the axial extensions comprise an aperture. Bradio et al, from the same field of endeavor teaches a similar prosthetic heart valve as shown in Figure 8B wherein the free ends of the axial extensions comprise an aperture (aperture 784, see paragraph [0163]) for the purpose of configuring the axial extension to attach to a delivery system. See paragraphs [0163]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve disclosed by Morin to include the aperture in each of the axial extensions taught by Morin in view of Bradio et al. in order to configure the axial extension to attach to a delivery system, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143 . 07-21-aia AIA Claim (s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0361419 (Morin et al.) in view of U.S. Patent Publication Number 2018/0325665 (Gurovich et al.) Regarding claim 8, Morin fails to disclose wherein the frame further comprising one or more commissure clasps, each clasp comprising a first commissure arm having a first indentation, a second commissure arm having a second indentation, and an opening therebetween configured to receive a commissure formed by two adjacent leaflets, wherein the first and second indentations are configured to receive a fastener such that the first and second commissure arms and the fastener restrict axial movement of the commissure received therein. Gurovich et al. from the same field of endeavor teaches a similar prosthetic heart valve as shown in Figures 67-70, wherein the frame further comprising one or more commissure clasps, each clasp comprising a first commissure arm having a first indentation, a second commissure arm having a second indentation, and an opening therebetween configured to receive a commissure formed by two adjacent leaflets, wherein the first and second indentations are configured to receive a fastener such that the first and second commissure arms and the fastener restrict axial movement of the commissure received therein for the purpose of securing adjacent portions of the leaflets together. See paragraphs [0165]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve disclosed by Morin to include the one or more commissure clasps taught by Gurovich in order to secure adjacent portions of the leaflets together, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143 . 07-27-aia AIA Claim(s) 9-14 is/are rejected under 35 U.S.C. 102( a)(1 ) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication Number 2021/0361419 (Morin et al.), U.S. Patent Publication Number 2016/0331531 (Quadri et al.) Regarding claims 9, 10 Morin et al. discloses as shown in Figure 5b a prosthetic heart valve comprising: a radially expandable frame (frame of stent, see paragraph [0022]) comprising an inflow end, an outflow end, and a plurality of struts (arm 372, arm 382, see paragraph [0041]) arranged to form a circumferentially extending row of struts forming the inflow end, wherein one or more selected struts have at least one opening extending therethrough; and a plurality of leaflets disposed inside the frame and configured to regulate the flow of blood in one direction through the frame, each leaflet comprising an outflow edge portion and an inflow edge portion; wherein the inflow edge portions of the leaflets are coupled to the selected struts of the frame with sutures extending through the openings, wherein the selected struts are arranged in pairs of adjacent selected struts. Morin et al. fails to disclose one or more selected struts have at least one opening extending therethrough. Quadri et al., from the same field of endeavor teaches a similar prosthetic heart valve as show in Figure 12, with a similar plurality of struts (anchors 570, see paragraph [0107]), wherein one or more selected struts have at least one opening (eyelet) extending therethrough for the purpose of accommodating a suture to attach material to the stent frame. See paragraph [0110]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve disclosed by Morin et al. to include the have at least one opening in order to accommodate the sutures used to attach the leaflets to the frame, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143. Morin et al fails to disclose wherein for a pair of adjacent selected struts, one of the selected struts is coupled to one of the leaflets and the other selected strut is coupled to an adjacent leaflet. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve disclosed by Morin et al. such that for a pair of adjacent selected struts, one of the selected struts is coupled to one of the leaflets and the other selected strut is coupled to an adjacent leaflet because it would only require a rearrangement of parts without changing how the device operates. In re Japikse , 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) Regarding claim 11, Morin et al. fails to disclose each selected strut has one or more openings extending radially therethrough. Quadri et al., from the same field of endeavor teaches a similar prosthetic heart valve as show in Figure 12, with a similar plurality of struts (anchors 570, see paragraph [0107]), wherein one or more selected struts have at least one opening (eyelet) extending therethrough for the purpose of accommodating a suture to attach material to the stent frame. See paragraph [0110]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve disclosed by Morin et al. to include the opening in each selected strut in order to accommodate the sutures used to attach the leaflets to the frame, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143. Regarding claim 12, 13 Morin et al. in view of Quadri et al. discloses wherein each selected strut comprises an inflow section, a midsection, and an outflow section, wherein the midsection of the selected struts has a circumferential width greater than a circumferential width of the inflow and outflow sections of the selected struts. See Figure 5b or Morin et al. and Figure 12 of Quadri et al. Morin et al. fails to disclose wherein the openings radially extend through the midsection of the struts. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve disclosed by Morin by rearranging the location of openings such that they were radially extend through the midsection of the struts because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse , 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) 07-22-aia AIA Claim (s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0361419 (Morin et al.), U.S. Patent Publication Number 2016/0331531 (Quadri et al.) as applied to claim 9 above, and further in view of U.S. Patent Publication Number 2018/0055631 (Morin et al. ‘631) Regarding claim 15, Morin fails to disclose the frame further comprising an outer skirt mounted to an outer surface of the frame, the outer skirt coupled to one or more axial extensions. Morin et al. ‘631,from the same field of endeavor teaches a similar prosthetic heart valve as shown in Figure 4A wherein the frame further comprising an outer skirt mounted to an outer surface of the frame, the outer skirt coupled to one or more axial extensions for the purpose of facilitating seal between the valve and the chamber of the heart it is disposed in. See paragraphs [0055], [0056]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve disclosed by Morin to include an outer skirt mounted to an outer surface of the frame, the outer skirt coupled to one or more axial extensions in order to facilitate sealing between the outer surface of the frame and the chamber of the heart it is disposed, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov . 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. /RICHARD G LOUIS/Primary Examiner, Art Unit 3771 Application/Control Number: 18/522,551 Page 2 Art Unit: 3771 Application/Control Number: 18/522,551 Page 3 Art Unit: 3771 Application/Control Number: 18/522,551 Page 4 Art Unit: 3771 Application/Control Number: 18/522,551 Page 5 Art Unit: 3771 Application/Control Number: 18/522,551 Page 6 Art Unit: 3771 Application/Control Number: 18/522,551 Page 7 Art Unit: 3771 Application/Control Number: 18/522,551 Page 8 Art Unit: 3771 Application/Control Number: 18/522,551 Page 9 Art Unit: 3771