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 . Claims 21-23, 25-30, 33-34, & 36-39 are pending and examined below.
Response to Arguments
Applicant's arguments filed 05/29/2026 have been fully considered but they are not persuasive. Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 9-11) and that the dependent claims rise and fall with the same arguments (page 11). Applicant's arguments are moot due to the additional reference applied to the newly added limitations, as detailed in the rejection below.
The drawing objections are withdrawn.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 21-23, 25-30, 33-34, & 36-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sigmon (US 20120116419 A1) in view of Ketai et al. (US 20110060407 A1) hereinafter, Ketai.
Regarding claim 21, Sigmon teaches an implantable device (20, Fig. 1, Sigmon) comprising:
a plurality of paddles (34 & 44, Fig. 1, Sigmon);
a cap (79, Fig. 1, Sigmon) or other attachment portion connected to the plurality of paddles configured such that movement of the cap or other attachment portion relative to a proximal end of the implantable device opens and closes the plurality of paddles (Figs. 1 & 4, Sigmon); and
an extendable coupler (70, Fig. 1, Sigmon) comprising an inner shaft (85-87, Fig. 1, Sigmon) and an outer sleeve (74, Fig. 1, Sigmon); wherein
the inner shaft (85-87, Fig. 1, Sigmon) is affixed to the cap (79, Fig. 1, Sigmon) or other attachment portion such that the inner shaft (85-87, Fig. 1, Sigmon) extends from the outer sleeve (74, Fig. 1, Sigmon) when the cap (79, Fig. 1, Sigmon) or other attachment portion moves away from the proximal end to open the paddles (¶0043-0045, Sigmon), wherein
the inner shaft (85-87, Fig. 1, Sigmon) comprises a radially outwardly extending step (76a, Fig. 1, Sigmon) at a proximal end of the inner shaft (85-87, Fig. 1, Sigmon).
Sigmon does not teach wherein the inner shaft is movable into and out of the outer sleeve. However, Ketai teaches devices for the endovascular repair of cardiac valves (abstract, Ketai)
wherein the inner shaft (3815, Fig. 38A, Ketai) is movable into and out of the outer sleeve (3810, Fig. 38A, Ketai);
such that the inner shaft (3815, Fig. 38A, Ketai) extends from the outer sleeve (3810, Fig. 38A, Ketai) when the cap or other attachment portion moves away.
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 teachings of Sigmon by incorporating the teaching above as taught by Ketai in order to push against the heart wall and the leaflet surface without damaging or puncturing the surfaces (¶0132, Ketai).
Regarding claim 22, Sigmon teaches
further comprising a coaptation element (50, Fig. 1, Sigmon) connected to the plurality of paddles, wherein the movement of the cap or other attachment portion relative to the coaptation element also opens and closes the plurality of paddles (¶0043-0045, Sigmon).
Regarding claim 23, Sigmon teaches
wherein the extendable coupler (70, Fig. 1, Sigmon) extends through the coaptation element (50, Fig. 1, Sigmon).
Regarding claim 25, Sigmon teaches
wherein the inner shaft (85-87, Fig. 1, Sigmon) is configured to telescope outward from the coaptation element (¶0043-0045, Sigmon).
Regarding claim 26, Sigmon teaches
wherein the inner shaft (85-87, Fig. 1, Sigmon) is coupled to the cap (79, Fig. 1, Sigmon) or other attachment portion that is coupled to the plurality of paddles (34 & 44, Fig. 1, Sigmon) for moving the plurality of paddles between an open position and a closed position (¶0043-0045, Sigmon).
Regarding claim 27, Sigmon teaches
wherein a distal end of the inner shaft (85-87, Fig. 1, Sigmon) is attachable to the cap (79, Fig. 1, Sigmon) or other attachment portion.
Regarding claim 28, Sigmon teaches
wherein the radially outwardly extending step (76a, Fig. 1, Sigmon) of the inner shaft limits extension of the inner shaft outwardly from the outer sleeve (Fig. 1, Sigmon).
Regarding claim 29, Sigmon teaches a system (10, Fig. 1, Sigmon) comprising:
an implantable device (20, Fig. 1, Sigmon) comprising:
a plurality of paddles (34 & 44, Fig. 1, Sigmon);
a coaptation element (50, Fig. 1, Sigmon) coupled to the plurality of paddles (34 & 44, Fig. 1, Sigmon);
a cap (79, Fig. 1, Sigmon) or other attachment portion connected to the plurality of paddles, configured such that movement of the cap or other attachment portion relative to a proximal end of the implantable device opens and closes the plurality of paddles (Figs. 1 & 4, Sigmon); and
an extendable coupler (70, Fig. 1, Sigmon) comprising an inner shaft (85-87, Fig. 1, Sigmon) and an outer sleeve (74, Fig. 1, Sigmon); wherein
the inner shaft (85-87, Fig. 1, Sigmon) is affixed to the cap (79, Fig. 1, Sigmon) or other attachment portion such that the inner shaft extends from the outer sleeve when the cap or other attachment portion moves away from the proximal end to open the paddles (¶0043-0045, Sigmon), wherein
the inner shaft (85-87, Fig. 1, Sigmon) comprises a radially outwardly extending step (76a, Fig. 1, Sigmon) at a proximal end of the inner shaft (85-87, Fig. 1, Sigmon);
a delivery catheter (90, Fig. 1, Sigmon); and
an actuation element (95, Fig. 1, Sigmon) that extends through the delivery catheter and is connected to the inner shaft of the extendable coupler (Fig. 1, Sigmon); wherein
extension of the actuation element (95, Fig. 1, Sigmon) extends the inner shaft (85-87, Fig. 1, Sigmon) of the extendable coupler from the coaptation element to move the cap or other attachment portion away from coaptation element and thereby move the plurality of paddles to an open position (¶0040, 0043-0045, Sigmon).
Sigmon does not teach wherein the inner shaft is movable into and out of the outer sleeve. However, Ketai teaches
wherein the inner shaft (3815, Fig. 38A, Ketai) is movable into and out of the outer sleeve (3810, Fig. 38A, Ketai);
such that the inner shaft (3815, Fig. 38A, Ketai) extends from the outer sleeve (3810, Fig. 38A, Ketai) when the cap or other attachment portion moves away.
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 teachings of Sigmon by incorporating the teaching above as taught by Ketai in order to push against the heart wall and the leaflet surface without damaging or puncturing the surfaces (¶0132, Ketai).
Regarding claim 30, Sigmon
wherein retraction of the actuation element (95, Fig. 1, Sigmon) retracts the inner shaft (85-87, Fig. 1, Sigmon) inwardly to move the cap (79, Fig. 1, Sigmon) or other attachment portion toward the coaptation element and thereby move the plurality of paddles (34 & 44, Fig. 4, Sigmon) to a closed position (Figs. 1 & 4, ¶0040, 0043-0045, Sigmon).
Sigmon does not teach retraction of the actuation element retracts the inner shaft inwardly into the outer sleeve. However, Ketai teaches
wherein retraction of the actuation element (3850, Fig. 38B, Ketai) retracts the inner shaft (3815, Fig. 38A, Ketai) inwardly into the outer sleeve (3810, tensioned to compress, Fig. 38A, ¶0134, Ketai).
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 teachings of Sigmon by incorporating the teaching above as taught by Ketai in order to push against the heart wall and the leaflet surface without damaging or puncturing the surfaces (¶0132, Ketai).
Regarding claim 33, Sigmon teaches
wherein the radially outwardly extending step (76a, Fig. 1, Sigmon) limits the extension of the inner shaft outwardly from the outer sleeve (Fig. 1, Sigmon).
Regarding claim 34, Sigmon does not teach retraction of the actuation element retracts the inner shaft inwardly into the outer sleeve. However, Ketai teaches
wherein retraction of the actuation element (3850, Fig. 38B, Ketai) retracts the inner shaft (3815, Fig. 38A, Ketai) inwardly into the outer sleeve (3810, tensioned to compress, Fig. 38A, ¶0134, Ketai).
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 teachings of Sigmon by incorporating the teaching above as taught by Ketai in order to push against the heart wall and the leaflet surface without damaging or puncturing the surfaces (¶0132, Ketai).
Regarding claim 36, Sigmon teaches
wherein the actuation element (95, Fig. 1, Sigmon) is configured to be decoupled from the extendable coupler after the implantable device is implanted (¶0046, Sigmon).
Regarding claim 37, Sigmon teaches
further comprising clasp control lines (63a & 64a, Fig. 1, Sigmon) and a pair of movable arms (63 & 64, Fig. 1, Sigmon); and wherein
the pair of movable arms (63 & 64, Fig. 1, Sigmon) are configured to move to an open position by applying tension to the clasp control lines (63a & 64a, Fig. 1, Sigmon).
Regarding claim 38, Sigmon teaches
an implantable device (20, Fig. 1, Sigmon) comprising:
a plurality of paddles (34 & 44, Fig. 1, Sigmon);
a coaptation element (50, Fig. 1, Sigmon) connected to the plurality of paddles (34 & 44, Fig. 1, Sigmon);
a cap (79, Fig. 1, Sigmon) or other attachment portion connected to the plurality of paddles (34 & 44, Fig. 1, Sigmon), configured such that movement of the cap or other attachment portion relative to a proximal end of the implantable device opens and closes the plurality of paddles (Figs. 1 & 4, Sigmon);
an extendable coupler (70, Fig. 1, Sigmon) comprising an inner shaft (85-87, Fig. 1, Sigmon) and an outer sleeve (74, Fig. 1, Sigmon); wherein
the inner shaft (85-87, Fig. 1, Sigmon) is affixed to the cap (79, Fig. 1, Sigmon) or other attachment portion such that inner shaft (85-87, Fig. 1, Sigmon) extends from the outer sleeve (74, Fig. 1, Sigmon) when the cap or other attachment portion moves away from the proximal end to open the paddles (¶0040, 0043-0045, Sigmon), wherein
the inner shaft (85-87, Fig. 1, Sigmon) comprises a radially outwardly extending step at a proximal end of the inner shaft; wherein
the movement of the cap (79, Fig. 1, Sigmon) or other attachment portion relative to the coaptation element also opens and closes the plurality of paddles (Figs. 1 & 4, ¶0040, 0043-0045, Sigmon); and wherein
the extendable coupler (70, Fig. 1, Sigmon) extends through the coaptation element (50, Fig. 1, Sigmon).
Sigmon does not teach wherein the inner shaft is movable into and out of the outer sleeve. However, Ketai teaches
wherein the inner shaft (3815, Fig. 38A, Ketai) is movable into and out of the outer sleeve (3810, Fig. 38A, Ketai);
such that inner shaft (3815, Fig. 38A, Ketai) extends from the outer sleeve (3810, Fig. 38A, Ketai) when the cap or other attachment portion moves away.
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 teachings of Sigmon by incorporating the teaching above as taught by Ketai in order to push against the heart wall and the leaflet surface without damaging or puncturing the surfaces (¶0132, Ketai).
Regarding claim 39, Sigmon teaches
further comprising a plurality of clasps (63b & 64b, Fig. 1, Sigmon) attached to the plurality of paddles (34 & 44, Fig. 1, Sigmon).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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