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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/31/2026 has been entered.
Priority
This application claims priority from provisional application 62/735,866 filed on 09/25/2018.
Status of Claims
Claims 1 and 3-15 are pending.
Claim 2 has been cancelled.
Information Disclosure Statement
The Information Disclosure Statement filed on 03/31/2026 has been considered by the examiner. It includes references stricken through because the office actions and other correspondence within other applications are not documents relevant to the patentability of the current claims. These documents may have citations to relevant documents, but the documents themselves are not relevant. They are not addressing the same claim language and were not drafted with the current claims in mind. Additionally, it is unclear how restriction requirements could be considered relevant to the patentability of the claims.
Specification
The disclosure is objected to because of the following informalities: missing/outdated priority information. Since the filing of this application at least one of the parent applications have been issued patent numbers. The priority information within the first line of the specification must be amended to disclose these patent numbers. Appropriate correction is required.
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, 9-11, and 14 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).
It is noted that the claim recitations directed at where the implant is inserted, the steps following the insertion, and effects of the insertion are considered to be intended use limitations. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. 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. As explained in more detail below, the prior art of record is intended to be inserted in the same fashion as the applicant's own invention, in the same part of the body, and includes the same basic structures and materials. Therefore, it is inherent that under some specific conditions the implant of the prior art combination will have the same ingrowth effects.
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 specifically mention the ingrowth.
Alon teaches a heart valve repair device (abstract) wherein the ring being adjustable in size ([0102] discloses the addition of cinching wires 62/64 which extend outside of the body) 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 ring of Kapadia to include the cinching mechanism for reducing the diameter of the ring and tissue ingrowth configuration, as taught by Alon, in order to prevent the implant from being dislodged ([0102]). The end result would maintain the ring of Kapadia which is not directly coupled to the tissue and the frame of Kapadia which couples to the tissue through substantial ingrowth.
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]).
Regarding claim 14, Kapadia further teaches the size of the ring is smaller than the size of the first portion of the frame (Figure 5 shows the ring is substantially smaller than all of the upper ring portions of the frame) and there is a bridging material between the ring and the first portion of the frame (Figure 5 shows the ring is connected to the upper ring portions by vertical struts as well as additional small circle components).
Regarding claim 15, Kapadia as modified by the teachings of Alon and Braido teach 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 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,
the ring being adjustable in size (see modification above adding the cinching means of Alon to the ring of Kapadia) and the ring being configured to reduce a diameter of the subject's native mitral annulus by a diameter of the ring being reduced, subsequent to tissue ingrowth to the mitral annulus repair device having occurred (as explained above this is considered to be language defining the intended use of the implant, additionally upon allowing for ingrowth from native tissue to the upper frame of Kapadia followed by applying cinching forces would result in the ring performing the applicant’s intended steps),
the mitral annulus repair device being configured such that there is not substantial tissue ingrowth with respect to the ring (this is dependent upon the implant site and condition of the surroundings, should the tissue be damaged or treated with growth inhibition it will not allow for substantial ingrowth on the ring, additionally the ring is a small circle of one or two loops there is inherently no possibility of substantial ingrowth because there is not enough surface area to support substantial ingrowth), there is substantial ingrowth with respect to a first portion of the frame (again this depends upon the implant site and condition of its surrounding, but do to the open framework and substantial surface area the first portion of the frame is fully capable of supporting substantial ingrowth), and the ring is configured to reduce the diameter of the mitral annulus by reducing a diameter of a second portion of the frame to which the ring is coupled (the addition of cinching means of Alon enables the user to reduce the diameter of the ring which attached to the upper frame with ingrowth coupling it to the surrounding tissue will result in a direct correlation between reducing the diameter of the ring and reducing the diameter of the mitral annulus), and the second portion of the frame causing the first portion of the frame to reduce the diameter of the mitral annulus (since the ring is directly connected to the second portion which is directly connected to the first portion, reducing the ring dimeter will directly cause the adjacent diameters to be reduced as well), wherein the size of the ring is smaller than the size of the first portion of the frame into which there is the tissue ingrowth (Figure 5 shows the ring is substantially smaller than all of the upper ring portions of the frame) and there is a bridging material between the ring and the first portion of the frame (Figure 5 shows the ring is connected to the upper ring portions by vertical struts as well as additional small circle components).
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.
Response to Arguments
Applicant's arguments filed 03/31/2026 have been fully considered but they are not persuasive.
The applicant argues that the prior art combination does not read upon the new amendments because Alon discloses his ring including barbs and tissue ingrowth. This argument is misplaced because the prior art combination does not take the teachings of barbs or ingrowth from Alon. The above combination merely takes the teaching of the cinching means. The barbs are not part of the combination, so this argument is considered moot.
The applicant further argues that if a ring is to be used for reducing the size of the mitral annulus it must be directly coupled to the mitral annulus. This is not persuasive because the cinching means is merely causing the ring to reduce size which reduces any flow into the upper frame. A person of ordinary skill in the art would recognize that the closing of an opening using cinching wires does not require attachment to additional or surrounding structures. A simple pull string on a backpack or small bag can be used to close the opening regardless of the environment surrounding it. As explained above the result of the modification if used in the same manner as the applicant intends, would have the same result. Additionally, since the claims are directed at the apparatus and not the method of using the invention, these steps and effects are given limited weight and if the prior art is configured to be capable of performing the task it is deemed to anticipate the intended use recitation.
Finally, the applicant argues that the new amendments clarify the ring is configured to reduce the diameter of the mitral annulus after tissue ingrowth occurs, which overcomes the previously identified initial configuration. This is not persuasive because the amount and location of ingrowth would fully depend upon the location and condition of the implant site. As explained above, the frame of the prior art combination is fully capable of substantial ingrowth in the same manner as the applicant’s own invention. With respect to the ring, it is not capable of substantial ingrowth because it has such a small surface area and simple ring structure. Furthermore, if the tissue around the ring is diseased, damaged or treated with an ingrowth preventing coating it will inherently not be capable of substantial ingrowth. Again, noting that the claims are directed at the apparatus and not a method of using the implant, this is a clearly identifiable situation where the prior art combination will only have ingrowth along the frame and not the ring. This will then allow the prior art combination to have its ring cinched, which will reduce the size of the of the annulus because the ring is connected to the frame which is connected to the tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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