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 .
Response to Arguments
Applicant's arguments filed 09/02/2025 regarding the 112 rejections of record are considered persuasive.
Applicant's arguments filed 09/02/2025 regarding the 103 rejection of record have been fully considered but they are not persuasive.
Applicant argues that the limitation of “there is not substantial tissue ingrowth with respect to the ring, there is substantial tissue ingrowth with respect to a first portion of the frame” is not taught because Alon teaches a ring that is directly coupled to tissue. In response to applicant's argument, it is noted that the features upon which applicant relies (i.e., direct coupling) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that tissue ingrowth does occur in Alon. Examiner agrees that tissue ingrowth can occur via the tissue-growth promotion tubes, however the coupling of the ring is primarily via barbs and when initially implanted substantial tissue growth is not present with respect to the ring.
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.
Claims 1, 3, 5-7, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kapadia (US 7,611,534 B2) in view of Alon (US 20140309730 A1) and Braido (US 2015/0209136 A1)..
Regarding claim 1, Kapadia teaches an apparatus for treating a subject with a diseased mitral valve (col 1, lines 10-16), the apparatus comprising: a mitral annulus repair device (col 1, lines 10-16) configured to be implanted within a left atrium of the subject (abstract) such that no portion of the mitral annulus repair device extends through the subject's mitral valve (see fig 5, docking portion does not extend completely through valve), the mitral annulus repair device being configured to generate ingrowth of the tissue of the subject to the mitral annulus repair device (col 6, lines 11-21, the device can be made out of PTFE, the same material as the ingrowth skirt in the instant application, meaning capable of the same ingrowth) the mitral annulus repair device comprising: a ring (element 63/64, fig 5) configured to be implanted within 15 mm of a native mitral annulus of the subject (element 64 engages annulus therefore is within 15 mm of it, ([0060]); and a frame (element 62/56/58, fig 5), extending upwardly from the ring (element 62/56/58, fig 5), the frame being configured to anchor the mitral annulus repair device within the left atrium (col 4, lines 32- col 5, lines19), prior to the tissue ingrowth to the mitral annulus repair device occurring (device is implanted and anchored before any tissue growth on device), by the frame expanding against inner walls and a roof of the left atrium(col 4, lines 32- col 5, lines19).
Kapadia does not teach a reduction in diameter of the ring or exactly mention ingrowth. Alon teaches a heart valve repair device (abstract) wherein the ring being adjustable in size ([0102]) and the ring being configured to reduce a diameter of the subject's native mitral annulus by a diameter of the ring being reduced ([0102]), subsequent to tissue ingrowth to the mitral annulus repair device having occurred ([0102]) and the device being configured to generate ingrowth of the tissue of the subject to the mitral annulus repair device ([0019]) and the ring (([0102]) is configured to reduce the diameter of the mitral annulus such that: there is not substantial tissue ingrowth with respect to the ring (([0102], ring does not have substantial ingrowth, only growth tissue tubes) by reducing a diameter of a second portion of the frame to which the ring is coupled, and the second portion of the frame causing the first portion of the frame to reduce the diameter of the mitral annulus (the ring reducing in Alon coupled to the frame of Kapadia would cause both the bottom part/top part/and annulus of the frame to also reduce via their physical connection).
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 device taught by Kapadia by including the reducing diameter and tissue ingrowth configuration, as taught by Alon, in order to prevent the implant from being dislodged ([0102]).
Kapadia in view of Alon does not teach wherein the mitral annulus repair device is configured, such that: there is substantial ingrowth with respect to a first portion of the frame. Braido teaches a valve repair device (abstract), there is substantial ingrowth with respect to a first portion of the frame (cuff 412 covers first part of frame, [0051], the device can be made out of PTFE, the same material as the ingrowth skirt in the instant application, meaning capable of the same ingrowth).
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 device taught by Kapadia in view of Alon by including the skirt, as taught by Braido, in order to better hold a prosthetic valve and allow tissue ingrowth ([0051]).
Regarding claim 3, Kapadia further teaches wherein the frame comprises a plurality of struts (col 4. Lines 51-55) that define a plurality of cells (fig 1, spaces between struts 68). Kapadia in view of Alon fails to teach a skirt. Braido teaches a valve repair device (abstract) wherein the first portion of the frame (portion coffered by cuff 312, fig 3/ cuff 412 in fig 4) extends from the ring until a height of at least 5 mm from the ring ([0076], 16mm > 5mm) and the first portion of the frame is covered in a fabric skirt (cuff 412 [0051], fabric is considered material for making covering (Cambridge dictionary)) that is configured to encourage tissue ingrowth thereto ([0051], the device can be made out of PTFE, the same material as the ingrowth skirt in the instant application, meaning capable of the same ingrowth)).
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 device taught by Kapadia in view of Alon by including the skirt, as taught by Braido, in order to better hold a prosthetic valve and allow tissue ingrowth ([0051]).
Regarding claim 5, Kapadia fails to teach a reducing ring. Alon teaches a heart valve repair device (abstract) wherein the ring is configured to be manually adjustable in size ([0044], manually cinched).
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 device taught by Kapadia by including the reducing diameter and tissue ingrowth configuration, as taught by Alon, in order to prevent the implant from being dislodged ([0102]).
Regarding claim 6, Kapadia fails to teach a reducing ring. Alon teaches a heart valve repair device (abstract) wherein the ring comprises a fabric hollow torus ([0098]), with a string disposed therein ([0098], loop), and the ring is configured to be manually adjustable in size by an operator pulling a portion of the string ([0044]]).
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 device taught by Kapadia by including the reducing diameter and tissue ingrowth configuration, as taught by Alon, in order to prevent the implant from being dislodged ([0102]).
Regarding claim 7, Kapadia fails to teach a reducing ring. Alon teaches a heart valve repair device (abstract) wherein the ring is configured to automatically adjust its size ([0123]).
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 device taught by Kapadia by including the reducing diameter and tissue ingrowth configuration, taught by Alon, in order to prevent the implant from being dislodged ([0102]).
Regarding claim 9, Kapadia further teaches wherein: the mitral annulus repair device is configured to be placed into the subject's left atrium (fig 5), via an interatrial septum of the subject (col 6, lines 58-61), by advancing the mitral annulus repair device in a lateral direction with respect to the left atrium (col 6, lines 53-64), along a longitudinal axis of the frame (fig 13, longitudinal axis of device goes left to right); and the ring is disposed laterally with respect to the frame (ring is lateral compared to frame), such that the ring is substantially parallel with the longitudinal axis of the frame (ring is parallel to longitudinal axis).
Regarding claim 10, Kapadia further teaches wherein the mitral annulus repair device is configured to be deployed within the subject's left atrium (fig 13), such that the longitudinal axis of the frame is substantially parallel to the subject's mitral annulus (fig 13, longitudinal axis of device goes left to right, therefore parallel to annulus).
Regarding claim 11, Kapadia in view of Alon fails to teach a sleeve. Braido teaches a valve repair device (abstract) wherein within at least a portion of the frame (element 306 in fig 3a), the struts of the frame (element 307 in fig 3a), are covered with fabric sleeves (element 312 covers portion of inner faces of 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 device taught by Kapadia in view of Alon by including the skirt, as taught by Braido, in order to better hold a prosthetic valve and allow tissue ingrowth ([0051]).
Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kapadia (US 7,611,534 B2) in view of Alon (US 20140309730 A1) and Braido (US 2015/0209136 A1) and in further view of Nauertz (US 6155972 A).
Regarding claim 4, Kapadia teaches wherein the cells can pe a predetermined size (col 4, lines 50-67). Kapadia in view of Alon and Braido does not teach wherein the cells defined by the struts define open areas of at least 3 square cm. Nauertz teaches a heart device (abstract) wherein the cells defined by the struts define open areas of at least 3 square cm (col 8, lines 50-63, 6.45 cm^2 is greater than 3 cm^2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teaching of Nauertz to the device taught by Kapadia in view of Alon and Braido, in order to minimize the amount of surface area of the heart in contact with the device (col 8, lines 50-63).
Regarding claim 12, Kapadia in view of Alon and Braido does not teach wherein at junctions between the struts that are covered with the fabric sleeves, adjacent fabric sleeves are stitched to each other. Nauertz teaches a heart device (abstract) wherein at junctions between the struts that are covered with the fabric sleeves, adjacent fabric sleeves are stitched to each other (col 9, lines 23-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teaching of Nauertz to the device taught by Kapadia in view of Alon and Braido, in order to have a cover with open cells and non-traumatic edges resting upon the heart (col 9, lines 40-45).
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kapadia (US 7,611,534 B2) in view of Alon (US 20140309730 A1), Braido (US 2015/0209136 A1), and Nauertz (US 6155972 A), and in further view of Keranen (US 20090299471 A1).
Regarding claim 8, Kapadia does not teach a reduction in diameter of the ring. Alon teaches a heart valve repair device (abstract) wherein the ring being adjustable in size (([0102]) and the ring being configured to reduce a diameter of the subject's native mitral annulus by a diameter of the ring being reduced ([0102]) and wherein the ring comprises a fabric hollow torus ([0098]).
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 device taught by Kapadia by including the reducing diameter and tissue ingrowth configuration, as taught by Alon, in order to prevent the implant from being dislodged ([0102]).
Kapadia in view of Alon, Bradio and Nauertz fails to teach the spring ring system. Keranen teaches a heart valve repair device (abstract) wherein the ring ([0089], support members) comprises a spring ([0089],coil) and a biodegradable material ([0089], biodegradable sheath) disposed therein such that the biodegradable material holds the spring in an expanded configuration ([0089]), and wherein the ring is configured to be automatically adjustable in size by the biodegradable material becoming degraded, and radial forces of the spring exerting a radially inward force ([0089]).
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 device taught by Kapadia in view of Alon, Braido, and Nauertz by including the spring system, as taught by Keranen, in order to reduce the diameter of the ring automatically through biodegrading ([0089]).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kapadia (US 7,611,534 B2) in view of Alon (US 20140309730 A1), Braido (US 2015/0209136 A1), Nauertz (US 6155972 A), and Keranen (US 20090299471 A1) and in further view of Chambers (US 20160242905 A1).
Regarding claim 13, Kapadia in view of Alon, Braido, Nauertz and Keranen does not exactly teach wherein the frame does not include additional anchoring portions for anchoring to any additional portions of the subject's body other than the inner walls and the roof of the left atrium. Chamber teaches a device for cardiac treatment (abstract) wherein the frame (support member 43) does not include additional anchoring portions for anchoring to any additional portions of the subject's body other than the inner walls and the roof of the left atrium [0049].
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 device taught by Kapadia in view of Alon, Braido, Nauertz, and Keranen by including no additional anchors, as taught by Chambers, in order to secure and anchor the frame solely within the left atrium.
Conclusion
THIS ACTION IS MADE FINAL. 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 HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 7:30PM-5:00PM EST M-F (occasionally off Fridays).
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 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.
/H.L.P./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774