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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 Status
Applicant’s Remarks and Amendments filed 6 October 2025 have been entered. Claims 26-27 are new. Claims 1-27 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-2 and 8-9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: reference characters 71 and 81 in Figure 1A. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference characters in the description in compliance with 37 CFR 1.121(b) 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 27 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 27 has been added to the claim set and states “…the proximal portion is coupler to the anchor delivery tool” in line 3. This portion of the claim introduces new matter. The drawings and specification do not exhibit or state the proximal portion of the anchor is coupled to the delivery tool. Figures 2A-G are the only figures to exhibit a delivery tool, but they fail to exhibit the proximal portion of the anchor at all, and further do not show it connected to the delivery tool. The specification further fails to disclose that the proximal portion of the anchor is coupled to a delivery device.
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.
Claims 1-2, 8-9, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Argento et al. (US 2020/0261220 A1), “Argento” in view of Patel et al. (US 2018/0055630 A1), “Patel”.
Regarding claim 1, Argento teaches a prosthesis for treating a diseased native valve (Fig. 6, valve prosthesis 10), the prosthesis comprising: a frame structure (Fig. 6, frame structure 12) having a plurality of leaflets therein (Fig. 6, valve segment 14); and a spiral anchor (Fig. 6, anchor 15) configured to extend around an outer circumference of the frame structure (Fig. 6, anchor 15 wraps around frame structure 12), the spiral anchor (Fig. 6, anchor 15) comprising a distal end (Fig. 6, free end 22 may be a distal end [0039]), a spiral portion (Fig. 6, wire 20), and a proximal portion (Fig. 6, first end may be a proximal end [0039]) that extends radially outwards relative to a circumference of the spiral portion (Fig. 6, free end 22 extends beyond circumference of anchor 15 and frame structure 12 [011]), but fails to teach the spiral anchor having its greatest cross-sectional diameter at the distal end.
Patel teaches a valve docking system wherein the spiral anchor having its greatest cross-sectional diameter at the distal end (Fig. 9, distal portion 18b of body 10 comprises a larger diameter than other portions of the docking device 1 [0071]). Patel discloses that these features may facilitate easier advancement of the docking devices around anatomical features and increase retention of the device after implantation [0052]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prosthesis taught by Argento with the distal tip comprising a larger cross-sectional diameter taught by Patel in order to more securely implant the prosthesis.
Regarding claim 2, Argento teaches wherein the proximal portion crosses the spiral portion to extend beyond the circumference of the spiral portion (Fig. 17, free end 22 extends beyond circumference of frame structure 12 [0118]).
Regarding claim 8, Argento teaches further comprising a delivery tether (Fig. 43D, inner shaft 52) configured to releasably engage with the proximal portion of the spiral anchor (Fig. 43D, delivery device 30’ and inner shaft 52 are configured to delivery valve prosthesis, including anchor 15 [0158]).
Regarding claim 9, Argento teaches wherein the spiral portion (Fig. 6, wire 20) is substantially contained within the plane (Fig. 6, anchor 15 comprising wire 20 comprises a flat spiral shape generally positioned within the same plane [0116]).
Regarding claim 26, Argento teaches wherein the spiral anchor (Fig. 6, anchor 15) is separate from the frame structure (the structures described may be embodied as separate components [0097]).
Claims 4-5 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Argento et al. (US 2020/0261220 A1), “Argento” in view of Patel et al. (US 2018/0055630 A1), “Patel”, and further in view of Patel et al. (US 2018/0177594 A1), “Patel 594”.
Regarding claim 4, Argento teaches proximal portion (Fig. 6, free end 22), but Argetno in view of Patel fails to explicitly state that it has a length of up to 5 mm. Patel 594 teaches a heart anchor device having proximal portion (Fig. 10, extension 140) with a length of up to 5 mm (Fig. 10, extension 140 has a length ranging from 5 to 100 mm [0121]). Patel 594 discloses that the extension of the docking device is intended to be limited in length near the native valve annulus in order to reduce the stress or strain applied to the native valve [0121]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the proximal portion taught by Argento in view of Patel with the length taught by Patel 594 in order to avoid damage to the native valve of the patient.
Regarding claim 5, Argento teaches proximal portion (Fig. 6, free end 22), but Argento in view of Patel fails to explicitly state that it has a length of up to 10 mm. Patel 594 teaches a heart anchor device having a proximal portion (Fig. 10, extension 140) with a length of up to 10 mm (Fig. 10, extension 140 has a length ranging from 5 to 100 mm [0121]). Patel 594 discloses that the extension of the docking device is intended to be limited in length near the native valve annulus in order to reduce the stress or strain applied to the native valve [0121]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the proximal portion taught by Argento in view of Patel with the length taught by Patel 594 in order to avoid damage to the native valve of the patient.
Regarding claim 27, Argento teaches the proximal portion (Fig. 6, free end 22) of the spiral anchor (Fig. 6, anchor 15), but Argento in view of Patel fails to teach it is configured to reduce an axial load on an anchor delivery tool when the proximal portion is coupled to the anchor delivery tool.
Patel 594 teaches a heart anchor device configured to reduce an axial load on an anchor delivery tool when the proximal portion is coupled to the anchor delivery tool (proximal end of docking device 1 is attached to delivery catheter [0162] and is therefore configured to reduce an axial load). Patel discloses that the pusher of the delivery device assists in repositioning of the docking device at any step of the delivery process [0162]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prosthesis taught by Argento in view of Patel with the delivery device taught by Patel 594 in order to allow for optimal positioning of the device during delivery.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Argento et al. (US 2020/0261220 A1), “Argento” in view of Patel et al. (US 2018/0055630 A1), “Patel” and further in view of Argento et al. (US 2020/0297491 A1), “Argento 491”.
Regarding claim 6, Argento teaches the proximal portion (Fig. 6, free end 22), but Argento in view of Patel fails to teach that it has a smaller cross-sectional area than that of the spiral portion. Argento 491 teaches a prosthetic cardiac valve with a proximal portion (Fig. 10, core wire 74) that has a smaller cross-sectional area than that of the spiral portion (Fig. 10, core wire 74 is disposed within anchor 15 (i.e., has a smaller cross-sectional area than anchor 15)).
Argento 491 discloses that the diameter and material of the core wire may be adjusted for desired amount of orientation and deflection of the distal tip of the core wire [0744]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the smaller cross-sectional area of the proximal portion taught by Argento 491 with the proximal portion taught by Argento in order to increase the delivery range of motion of the device during implantation.
Regarding claim 7, Argento teaches the proximal portion (Fig. 6, free end 22), but Argento in view of Patel fails to teach it comprises an abutment at the transition between the proximal portion and the spiral portion. Argento 491 teaches a prosthetic cardiac valve having an abutment (Fig. 50, deflecting feature 23) at the transition between the proximal portion and the spiral portion (Fig. 50, deflecting feature 23 is between free end 22 and anchor 15).
Argento 491 discloses that the deflecting feature causes the free end of the anchor to wiggle or deflect away from the longitudinal axis of the delivery device and cause a change in the deployment angle of the free end [0717]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the proximal portion taught by Argento with the abutment taught by Argento 491 in order to increase the delivery range of motion of the device during implantation.
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.
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/G.G.R./ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774