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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/14/2025 has been entered.
Response to Arguments
Applicant's arguments filed 07/14/2025 have been fully considered but they are not persuasive. Applicant argues that the amendments to the independent claim overcome the rejections of record (page 10) and that the dependent claims rise and fall with the same arguments (page 10). Applicant's arguments are moot due to the additional reference applied to the newly added limitations, as detailed in the rejection below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because
-reference character “3608” has been used to designate two different parts in Fig. 37,
-reference character “3702” has been used to designate two different parts in Figs. 37 & 38,
-reference character “3702” has been used to designate both “first radially outwardly extending step 3702” in [0350 & 0352] of the specification and “first radially inwardly extending step 3702” in [0351] of the specification,
-reference character “3704” has been used to designate both “first radially inwardly extending step 3704” in [0350 & 0352] of the specification and “first radially outwardly extending step 3704” in [0351] of the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 21-23, 25-30, 33-34, 36-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sigmon (US 20120116419 A1).
Regarding claim 21, Sigmon teaches an implantable device (20, Fig. 1) comprising:
a plurality of paddles (34 & 44, Fig. 1);
a cap (79, Fig. 1) 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); and
an extendable coupler (70, Fig. 1) comprising an inner shaft (85-87, Fig. 1) and an outer sleeve (74, Fig. 1); wherein
the inner shaft (85-87, Fig. 1) is affixed to the cap (79, Fig. 1) or other attachment portion such that the inner shaft (85-87, Fig. 1) extends from the outer sleeve (74, Fig. 1) when the cap (79, Fig. 1) or other attachment portion moves away from the proximal end to open the paddles (¶0043-0045), wherein
the inner shaft (85-87, Fig. 1) comprises a radially outwardly extending step (76a, Fig. 1) at a proximal end of the inner shaft (85-87, Fig. 1).
Regarding claim 22, Sigmon teaches
further comprising a coaptation element (50, Fig. 1) 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).
Regarding claim 23, Sigmon teaches
wherein the extendable coupler (70, Fig. 1) extends through the coaptation element (50, Fig. 1).
Regarding claim 25, Sigmon teaches
wherein the inner shaft (85-87, Fig. 1) is configured to telescope outward from the coaptation element (¶0043-0045).
Regarding claim 26, Sigmon teaches
wherein the inner shaft (85-87, Fig. 1) is coupled to the cap (79, Fig. 1) or other attachment portion that is coupled to the plurality of paddles (34 & 44, Fig. 1) for moving the plurality of paddles between an open position and a closed position (¶0043-0045).
Regarding claim 27, Sigmon teaches
wherein a distal end of the inner shaft (85-87, Fig. 1) is attachable to the cap (79, Fig. 1) or other attachment portion.
Regarding claim 28, Sigmon teaches
wherein the radially outwardly extending step (76a, Fig. 1) of the inner shaft limits extension of the inner shaft outwardly from the outer sleeve (Fig. 1).
Regarding claim 29, Sigmon teaches a system (10, Fig. 1) comprising:
an implantable device (20, Fig. 1) comprising:
a plurality of paddles (34 & 44, Fig. 1);
a coaptation element (50, Fig. 1) coupled to the plurality of paddles (34 & 44, Fig. 1);
a cap (79, Fig. 1) 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); and
an extendable coupler (70, Fig. 1) comprising an inner shaft (85-87, Fig. 1) and an outer sleeve (74, Fig. 1); wherein
the inner shaft (85-87, Fig. 1) is affixed to the cap (79, Fig. 1) 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), wherein
the inner shaft (85-87, Fig. 1) comprises a radially outwardly extending step (76a, Fig. 1) at a proximal end of the inner shaft (85-87, Fig. 1);
a delivery catheter (90, Fig. 1); and
an actuation element (95, Fig. 1) that extends through the delivery catheter and is connected to the inner shaft of the extendable coupler (Fig. 1); wherein
extension of the actuation element (95, Fig. 1) extends the inner shaft (85-87, Fig. 1) 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).
Regarding claim 30, Sigmon teaches
wherein retraction of the actuation element (95, Fig. 1) retracts the inner shaft (85-87, Fig. 1) inwardly into the outer sleeve (74, Fig. 1) to move the cap (79, Fig. 1) or other attachment portion toward the coaptation element and thereby move the plurality of paddles (34 & 44, Fig. 4) to a closed position (Figs. 1 & 4, ¶0040, 0043-0045).
Regarding claim 33, Sigmon teaches
wherein the radially outwardly extending step (76a, Fig. 1) limits the extension of the inner shaft outwardly from the outer sleeve (Fig. 1).
Regarding claim 34, Sigmon teaches
wherein the retraction of the actuation element (95, Fig. 1) retracts the inner shaft inwardly into the outer sleeve (Figs. 1 & 4, ¶0040, 0043-0045).
Regarding claim 36, Sigmon teaches
wherein the actuation element (95, Fig. 1) is configured to be decoupled from the extendable coupler after the implantable device is implanted (¶0046).
Regarding claim 37, Sigmon teaches
further comprising clasp control lines (63a & 64a, Fig. 1) and a pair of movable arms (63 & 64, Fig. 1); and wherein
the pair of movable arms (63 & 64, Fig. 1) are configured to move to an open position by applying tension to the clasp control lines (63a & 64a, Fig. 1).
Regarding claim 38, Sigmon teaches
an implantable device (20, Fig. 1) comprising:
a plurality of paddles (34 & 44, Fig. 1);
a coaptation element (50, Fig. 1) connected to the plurality of paddles (34 & 44, Fig. 1);
a cap (79, Fig. 1) or other attachment portion connected to the plurality of paddles (34 & 44, Fig. 1), 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);
an extendable coupler (70, Fig. 1) comprising an inner shaft (85-87, Fig. 1) and an outer sleeve (74, Fig. 1); wherein
the inner shaft (85-87, Fig. 1) is affixed to the cap (79, Fig. 1) or other attachment portion such that inner shaft (85-87, Fig. 1) extends from the outer sleeve (74, Fig. 1) when the cap or other attachment portion moves away from the proximal end to open the paddles (¶0040, 0043-0045), wherein
the inner shaft (85-87, Fig. 1) comprises a radially outwardly extending step at a proximal end of the inner shaft; wherein
the movement of the cap (79, Fig. 1) or other attachment portion relative to the coaptation element also opens and closes the plurality of paddles (Figs. 1 & 4, ¶0040, 0043-0045); and wherein
the extendable coupler (70, Fig. 1) extends through the coaptation element (50, Fig. 1).
Regarding claim 39, Sigmon teaches
further comprising a plurality of clasps (63b & 64b, Fig. 1) attached to the plurality of paddles (34 & 44, Fig. 1).
Conclusion
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/K.X.W./
Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774