CTNF 18/510,434 CTNF 94560 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. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 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. 07-12-aia AIA (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. 07-15-aia AIA Claim(s) 18-22, 25, and 29-32 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Accola (US Pub No.: 2013/0261741) . Regarding claim 18, Accola (US Pub No.: 2013/0261741) discloses a heart valve prosthesis comprising: a frame (being the device shown in figure 2, shown in annotated figure 1 below), wherein the frame is radially compressible and radially expandable (radial expansion disclosed in [0022], where radial expansion implies radial compression. Compression of valve in [0060]), the frame comprising: including an inflow rim; and an outflow portion (shown in annotated figure 1 below), wherein the inflow rim flares radially outward from the outflow portion (shown in annotated figure 1 below where the inflow rim flares outward); and a prosthetic heart valve coupled to an inner surface of the outflow portion of the frame (in [0032], as the heart valve is surrounded by support members, the valve is coupled to an inner portion of the outflow portion), wherein the inflow rim is rotatable relative to the outflow portion of the frame (disclosed in [0023] and [0038]). PNG media_image1.png 421 600 media_image1.png Greyscale Annotated Figure 1 Regarding claim 19, Accola discloses the heart valve prosthesis of 18, further comprising barbs extending from the inflow rim (shown in annotated figure 1 above), wherein the barbs are configured to engage tissue by rotation of the inflow rim relative to the outflow portion in situ (fasteners on the assembly ring in [0023] that engage a tissue, fasteners are barbs as per claim 5 of Accola). Regarding claim 20, Accola discloses the heart valve prosthesis of claim 19, wherein the barbs extend from a downstream surface of the inflow rim (shown in annotated figure 1). Regarding claim 21, Accola discloses the heart valve prosthesis of claim 19, wherein the barbs extend circumferentially (shown in annotated figure 1) such that rotation thereof causes the barbs to engage tissue (as fasteners are on the assembly ring in [0023] that engage a tissue, a rotation will cause the barbs to engage a tissue). Regarding claim 22, Accola discloses the heart valve prosthesis of claim 17, wherein the inflow rim is rotatably coupled to the outflow portion at a joint (being the pivot points 105, and 119, pivot points disclosed in [0035]. A pivot point is also assumed to be at part 107 as per figure 3). Regarding claim 25, Accola discloses the heart valve prosthesis of claim 22, wherein the joint is configured to enable rotation between the inflow rim and the outflow portion (rotation of an annular ring between the inflow and outflow portion in [0023]), but not longitudinal separation of the inflow rim and the outflow portion (no separation between the inflow rim and outflow portion is disclosed). Regarding claim 29, Accola discloses the heart valve prosthesis of claim 17, further comprising a plurality of arms coupled to the outflow portion of the frame (being the being the linkers 114, 116, and 123 in figure 3 and [0035]-[0036], where part 123 and 120 in figure 3 are also depicted as linkers). Regarding claim 30, Accola discloses the heart valve prosthesis of claim 29, wherein the plurality of arms are coupled to an outflow end of the outflow portion (shown in figure 3 where parts 114, 116, 123 (disclosed as linkers in [0036] and part 124 in figure 3 are coupled to the outflow portion at parts 104 and 106). Regarding claim 31, Accola discloses the heart valve prosthesis of claim 30, wherein the plurality of arms are configured to capture native leaflets of a native heart valve between the plurality of arms and the outflow portion of the frame (as per the arrangement of figure 3, the arms disclosed in figure 3 and [0036] will interface with the leaflets and valve portions of the device). Regarding claim 32, Accola discloses the heart valve prosthesis of claim 30, wherein the arms extend longitudinally away from the outflow end of outflow portion (shown in figure 3, where the top part 106 is toward the outflow end) with the frame in a radially compressed configuration (as parts 104 and 106 expand in the body, the interfacing between the arms and parts 104 and 106 will be when they are compressed as the arms are used for an implanting of the device. The arms are used in a linkage device used for deployment of a heart valve in [0028]), and are configured to fold back to extend towards the inflow rim in a radially expanded configuration of the frame (folding toward an inflow rim shown in figure 3, inflow rim is about part 104, with 104 shown in figures 1 and 3) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 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) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Accola (US Pub No.: 2013/0261741) in view of Flaction (US Pub No.: 2018/0263765) . Regarding claim 23, Accola (US Pub No.: 2013/0261741) teaches the heart valve prosthesis of claim 22, wherein the joint is a flexible material. Instead, Flaction (US Pub No.: 2018/0263765) discloses wherein the joint is a flexible material (in [0021] and [0031], a joint made of fabric or fibers is present). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the material for a valve joint as presented in Flaction for the purpose of providing a joint that provides a reliable fastening between a valve and something else (fastening to a film in [0021]) with the fabric (with a polymeric material in [0037]) allowing for a recapture and reshaping of the device in [0037]. Regarding claim 24, Accola in view of Flaction teach the heart valve prosthesis of claim 23, wherein the flexible material is a fabric material. However, Accola does not teach wherein the flexible material is a fabric material(in [0021] and [0031]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the material for a valve joint as presented in Flaction for the purpose of providing a joint that provides a reliable fastening between a valve and something else (fastening to a film in [0021]) with the fabric (with a polymeric material in [0037]) allowing for a recapture and reshaping of the device in [0037] . 07-21-aia AIA Claim (s) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Accola (US Pub No.: 2013/0261741) in view of Salahieh (US Pub No.: 2007/0244552) . Regarding claim 26, Accola discloses the heart valve prosthesis of claim 22, wherein the joint comprises a groove in one of the inflow rim or the outflow portion (being the indentation at parts 105 and 119). However, Accola does not teach and a lip in the other of the inflow rim or the outflow portion (shown visually in figure 3 where a rim is the wall parts of part 104 and 106 present about parts 105 and 119), wherein the lip is disposed in the groove to enable rotation and restrain longitudinal movement of the inflow rim and the outflow portion relative to each other (the lips extend within the groove parts 119 and 104 to which parts 114 and 116 extend within). Instead, Salahieh teaches a lip in the other of the inflow rim or the outflow portion (lip disclosed in [0155]), wherein the lip is disposed in the groove to enable rotation and restrain longitudinal movement of the inflow rim and the outflow portion relative to each other (the lip part 560 may be “dynamically repositioned until it properly engages the valve leaflets) in [0171] with a rotation in [0178]. A restraining of longitudinal movement is also implied as the lip doubles over the groove section in [0155] and shown in figures 39A and 41A). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the lip and groove arrangement of Salahieh into Accola to which the lip will be about the outflow portion of Accola for the purpose of providing a portion on an outflow portion that will have locking elements to lock with a valve portion, as disclosed in [0092] and shown in figure 41A. Regarding claim 27, Accola teaches the heart valve prosthesis of claim 22. However, Accola does not teach wherein the joint comprises a tubular portion of the inflow rim extending towards outflow portion, a lip of the tubular portion, and a groove disposed at an inflow end of the outflow portion, wherein the lip is disposed in the groove to enable relative rotation between the inflow rim and the outflow portion. Instead, Salahieh (US Pub No.: 2007/0244552) discloses wherein the joint (the bending sections shown in figures 39A-39B, detailed in [0155]) comprises a tubular portion of the inflow rim extending towards outflow portion (figure 39B forms a tubular portion, shown in figures 41A-41B), a lip of the tubular portion (lip disclosed in [0155]), and a groove disposed at an inflow end of the outflow portion (shown in figure 41A and in [0155]), wherein the lip is disposed in the groove (in figure 41A) to enable relative rotation between the inflow rim and the outflow portion (the lip part 560 may be “dynamically repositioned until it properly engages the valve leaflets) in [0171] with a rotation in [0178]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the lip and groove arrangement of Salahieh into Accola to which the lip will be about the outflow portion of Accola for the purpose of providing a portion on an outflow portion that will have locking elements to lock with a valve portion, as disclosed in [0092] and shown in figure 41A. Regarding claim 28, Accola in view of Salahieh teaches the heart valve prosthesis of claim 27. However, Accola does not teach wherein the lip extends radially inward from the tubular portion of the inflow rim. Instead, Salahieh teaches wherein the lip extends radially inward from the tubular portion of the inflow rim (shown in figure 41A-41B, where the lip is part 560). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the lip and groove arrangement of Salahieh into Accola to which the lip will be about the outflow portion of Accola for the purpose of providing a portion on an outflow portion that will have locking elements to lock with a valve portion, as disclosed in [0092] and shown in figure 41A . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hacohen (US Patent No.: 11,141,268) considered for a prosthetic valve with joints and folding segments in column 2 lines 33-43. Cox (US Pub No.: 2014/0303719) considered for an expandable prosthetic valve in the abstract with barbs 160 in figure 3 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to AREN PATEL whose telephone number is (571)272-0144. The examiner can normally be reached 7:00 - 4:30 M-Th. 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 C. 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. /AREN PATEL/Examiner, Art Unit 3774 /YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774 Application/Control Number: 18/510,434 Page 2 Art Unit: 3774 Application/Control Number: 18/510,434 Page 3 Art Unit: 3774 Application/Control Number: 18/510,434 Page 4 Art Unit: 3774 Application/Control Number: 18/510,434 Page 5 Art Unit: 3774 Application/Control Number: 18/510,434 Page 6 Art Unit: 3774 Application/Control Number: 18/510,434 Page 7 Art Unit: 3774 Application/Control Number: 18/510,434 Page 8 Art Unit: 3774 Application/Control Number: 18/510,434 Page 9 Art Unit: 3774