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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 29-33,39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 29 recites an additional structure “a frame”.
Claim 39 recites additional structures: “a frame” and “an anchor”.
It is unclear if these are references to previously defined frame and anchor or additional structures.
Claims 30-33 depend from and include the limitations of claim 29 supra.
Claim Rejections - 35 USC § 102
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.
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 –
(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(s) 23-28,34-38,40 is/are rejected under 35 U.S.C. 102a(1) as being anticipated by Cecere USPUB 20150127091.
Regarding claim 23, Cecere discloses: system for annuloplasty comprising: a frame 100 (Fig 9-10) having a proximal end 106, a distal end 104 and struts 102 joined at one of the proximal end or the distal end of the frame; and an implant 10 (Fig 1-9) comprising: a plurality of anchors 18; and a plurality of anchor housings 17,17a,17b, at least one anchor housing configured to support and retain one of the plurality of anchors, at least one anchor housing comprising a release mechanism 17’ (Figured 7,8a,8b,9,10) configured to releasably couple the at least one anchor housing to the frame (Fig 10).
Re: claim 24 Cecere discloses the at least one anchor housing includes: a bore extending from a proximal end of the at least one anchor housing through the distal end of the at least one anchor housing; a slot extending longitudinally through a wall of the bore; and wherein the release mechanism includes a retention tab 17’ disposed within the slot, the retention tab comprising a distal foot, a proximal head, and an arm extending from the distal foot to the proximal head (portions of 17’), wherein the retention tab includes a first configuration wherein an internal face of the proximal head extends into the bore and a second configuration where the internal face of the proximal head is aligned with the wall of the bore (shown in Figure 8B and Figure 7 dependent on curvature of implant 10).
Re: claim 25,26,27 Cecere discloses the system of claim 24 as described above and the bore is fully capable to accept “an anchor” and the anchor comprises a drive shaft including a proximal connector, a distal anchor shaft coupled to the proximal connector and a collar extending at least partially around the distal anchor shaft; the bore and the collar are sized to enable distal translation of the collar within the bore of the anchor housing; a first diameter of the proximal connector is less than a second diameter of the collar and distal translation of the collar beyond the proximal head of the retention tab causes the proximal head towards the second configuration to retain the anchor in the anchor housing.
Note in claims 25-27, the claims refer to structures which are not structurally required by the claimed system.
Re claim 28 Cecere disclose the system of claim 26 wherein the proximal head of the retention tab includes a frame engagement feature disposed on an exterior face of the proximal head, the frame engagement feature sized to mate with an anchor housing engagement feature of the frame, and wherein in the first configuration of the retention tab the frame engagement feature engages the anchor housing engagement feature, and in the second configuration the frame engagement feature releases the anchor housing engagement feature to release the frame from the implant. See Figures 9-10 and paragraph 0088
Re: claim 34 Cecere discloses The system of claim 23 wherein a subset of anchor housings each include a lumen extending therethrough, and wherein the implant further comprises a cinch cord extending through the lumen of the subset of anchor housings to join the subset of anchor housings. See Figure 10 and paragraph 0078.
Re: claim 35 Cecere discloses The system of claim 34 wherein the subset of anchor housings comprises a primary housing and a secondary housing, and the lumen extends through the secondary housing. See Figure 10.
Re claim 36 Cecere discloses An implant comprising a plurality of anchors 18; at least two anchor housings 17,17a,17b, each anchor housing comprising: a release mechanism 17’ configured to releasably couple the anchor housing to an implant delivery system 100; and a cinch lumen extending through a portion of the anchor housing; and a cinch cord extending through the cinch lumen of the at least two anchor housings to join the at least two anchor housings. See Figure 9,10 and paragraph 0078
Re claim 37 Cecere discloses the at least one anchor housing includes: a bore extending from a proximal end of the at least one anchor housing through the distal end of the at least one anchor housing; a slot extending longitudinally through a wall of the bore; and wherein the release mechanism includes a retention tab 17’ disposed within the slot, the retention tab comprising a distal foot, a proximal head, and an arm extending from the distal foot to the proximal head (portions of 17’), wherein the retention tab includes a first configuration wherein an internal face of the proximal head extends into the bore and a second configuration where the internal face of the proximal head is aligned with the wall of the bore (shown in Figure 8B and Figure 7 dependent on curvature of implant 10).
Re claim 38 Cecere disclose the system of claim 37 wherein the delivery system includes a frame 100 and a proximal head of the retention tab includes a frame engagement feature disposed on an exterior face of the proximal head, the frame engagement feature sized to mate with an anchor housing engagement feature of the frame, and wherein in the first configuration of the retention tab the frame engagement feature engages the anchor housing engagement feature, and in the second configuration the frame engagement feature releases the anchor housing engagement feature to release the frame from the implant. See Figures 9-10 and paragraph 0088.
Re: claim 40 Cecere, as described supra discloses an annuloplasty method including the steps of:
deploying an implant system to a valve annulus, the implant system comprising a frame 100 and an implant 10 comprising a plurality of anchors 18 translatably supported by a plurality of anchor housings 17, the plurality of anchor housings releasably coupled to the frame by a release mechanism 17’ of each anchor housing; securing the implant to the valve annulus by driving the plurality of anchors at least partially through the plurality of anchor housings and into the valve annulus; cinching the valve annulus using a cinching mechanism of the frame; releasing the frame from the plurality of anchor housings using the release mechanism of each anchor housing; and withdrawing the frame from the valve annulus. See paragraphs 0075-0078,0082-0088.
Claim(s) 36,40 is/are rejected under 35 U.S.C. 102a(1) as being anticipated by Lashinksi USPUB 20180228610.
Re claim 36 Lashinski discloses (Fig 21) an implant comprising a plurality of anchors 232; at least two anchor housings 210/234, each anchor housing comprising: a release mechanism 260/252 configured to releasably couple the anchor housing to an implant delivery system 40; and a cinch lumen 224 extending through a portion of the anchor housing; and a cinch cord 222 extending through the cinch lumen of the at least two anchor housings to join the at least two anchor housings. See Figures 21-22.
Re: claim 40 Lashinksi, as described supra discloses an annuloplasty method including the steps of: deploying an implant system to a valve annulus, the implant system comprising a frame 40 and an implant 10 comprising a plurality of anchors 232 translatably supported by a plurality of anchor housings 210/234, the plurality of anchor housings releasably coupled to the frame by a release mechanism 252/260 of each anchor housing; securing the implant to the valve annulus by driving the plurality of anchors at least partially through the plurality of anchor housings and into the valve annulus; cinching the valve annulus using a cinching mechanism of the frame; releasing the frame from the plurality of anchor housings using the release mechanism of each anchor housing; and withdrawing the frame from the valve annulus. See paragraphs 0183,0194-0198.
Allowable Subject Matter
Claims 29-33,39,41-42 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to teach nor substantially render obvious:
Regarding claim 29: a system for annuloplasty comprising the system of claim 23 wherein the release mechanism comprises a primary housing coupled to the frame and a secondary housing releasably coupled to the primary housing by an anchor.
Claims 30-33 depend from and include the limitations of claim 29.
Regarding claim 39, the implant of claims 36-38 further including the implant delivery system includes a frame and the release mechanism of the at least one anchor housing includes a primary housing coupled to the frame and a secondary housing releasably coupled to the primary housing by an anchor, and the cinch lumen is provided by the secondary housing.
Regarding claim 41, the method of claim 40 further requiring wherein at least one anchor housing includes a bore extending from a proximal end of the at least one anchor housing through a distal end of the at least one anchor housing, and the release mechanism of each anchor housing includes a retention tab disposed within the bore and having a frame engagement feature configured for mated engagement with an anchor engagement feature of the frame when the retention tab is in an unbiased state, and the step of distally translating an anchor until retention tab returns to unbiased state.
Regarding claim 42, the method of claim 40 further requiring the at least one anchor housing includes a primary housing coupled to the frame, a secondary housing releasably coupled to the primary housing by an anchor, a first anchor engagement feature disposed within a primary bore of the primary housing, and a second anchor engagement feature disposed within a secondary bore of the secondary housing, the second anchor engagement feature extending further centripetally within the second bore than the first anchor engagement feature extends within the primary bore, and wherein the step of releasing the frame from the plurality of anchor housings includes the step of distally translating the plurality of anchors through the primary housings and the secondary housings until proximal anchor collars of the plurality of anchors extend into the secondary housing and are precluded from further distal translation by the second anchor engagement feature.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H MATTHEWS whose telephone number is (571)272-4753. The examiner can normally be reached Monday-Friday (9-5).
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/WILLIAM H MATTHEWS/Primary Examiner, Art Unit 3774