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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/27/25 has been entered.
Response to Arguments
Applicant's arguments filed 08/27/25 have been fully considered but they are not persuasive.
On pages 7-8 regarding prior art rejections Applicant argues the prior art fails to teach a tubular braided frame with loops that operate with a delivery mechanism, for attaching a leaflet structure and for enhancing or reducing radial force on the system.
Th Examiner respectfully points out the claims do not require a delivery mechanism for attaching a leaflet structure and a delivery mechanism for enhancing or reducing radial force on the system, as Applicant is arguing. This is accordingly unpersuasive.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the leaflet assembly being connected to the one or more of the plurality of loops, while the suture lines also extend through the loops must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Special definitions:
“Belly stich” is defined as: a stitch originating at the edge seams of the Z-valve insert and following a wire to define an edge of a leaflet, with the option to attach to one of the wires of the frame and/or cuff. ([0039])
Claim Rejections - 35 USC § 112
Claims 1-8 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 1 is indefinite for claiming the leaflet assembly is connected to one or more of the plurality of loops, and also states that the suture lines of the delivery system goes through the plurality of loops. The specification [0035] states that loops (Figure 2 item 220), which are distinct from commissure posts 210, “allow for means of looping sutures to a delivery mechanism” and also “provide an attachment means for the leaflet structure 120”. However, the specification does not discuss (and the figures do not show) how a loop that is used to attach a leaflet would also be able to be used to thread a suture line of a delivery system therethrough. As the Examiner best understands, the leaflets would interfere with the suture of the delivery mechanism and the two could not both be attached to the same structure at the same time.
Claim 8 is indefinite since the specification special defines the term “belly stitch” as “a stitch originating at the edge seams of the Z-valve insert and following a wire to define an edge of a leaflet, with the option to attach to one of the wires of the frame and/or cuff”, since there is neither an “edge seam”, a “Z-valve insert”, or “a wire” present in the language of the claims, and these structures cannot be adequately equated to anything specific in the claims. It is unclear accordingly what scope the term has, as it does not appear to make sense within the claim when the special definition is applied.
Remaining claims are indefinite for depending on an indefinite claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alon et al. (US 20100049313 A1) hereinafter known as Alon in view of Haug et al. (US 20050137693 A1) hereinafter known as Haug.
Regarding claim 1 Alon discloses a replacement heart-valve system ([0002]) comprising:
a replacement heart valve (Figure 49 item 12) comprising a tubular frame (Figure 49 item 12), and a leaflet assembly (Figure 6),
wherein the frame comprises an inflow end (Figure 1 item 26) and an outflow end (Figure 1 item 27),and one or more engagement structures on the inflow or outflow end (Figure 49 item 502),
wherein the leaflet assembly is connected to one or more of the plurality of engagement structures (Figures 1-2 show a part 38 of the leaflet 34, to attach to the stent frame, which carries the engagement structure (represented in these figures as item 32). Accordingly, the leaflet assembly is connected to the engagement structures via the frame)
a delivery system (Figure 49 item 412) comprising one or more suture lines (Figures 48-49 item 500) and one or more bushings (Figures 41-42 items 404, 412) connected to a channel retained in a threaded rod (Figures 41-42 item 422 shows the threaded rod with internal channel holding the bushings);
wherein the one or more suture lines goes through the engagement structure, through the bushings, and channel (Figures 48-49 along with Figure 41),
but is silent with regards to the frame bring braided,
the engagement structures being loops which comprise at least one 360-degree turn that enhances or reduces the radial force of the braided frame.
However, regarding claim 1, while Alon teaches the structure which engages the sutures 500 is a hook (Figure 49- item 502), Alon also teaches an embodiment in which a loop engages with the catheter engagement mechanism (Figure 1 item 32). It would have been obvious to the person of ordinary skill in the art at the time the invention was filed to modify the system of Alon so that the engagement portion of the tubular frame comprised the loop (e.g. “looping structures”) (and sutures did not) as opposed to the hook (which engaged looped sutures) since Alon teaches these as being alternative embodiments of different shapes but serving the same purpose. The courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B).
Further, regarding claim 1 Haug teaches wherein heart valves (Abstract) include braided frames (Abstract) which comprise engagement structures in the form of loops, which comprise at least one 360 degree turn (Figures 5e-j, 5l, 5n-o) that enhances or reduces the radial force of the braided frame (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Haug discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus.).
Regarding claim 2 the Alon Haug Combination teaches the system of claim 1 substantially as is claimed,
wherein Haug further teaches the frame is a braid of one or more wires (Abstract).
Regarding claim 3 the Alon Haug Combination teaches the system of claim 2 substantially as is claimed,
wherein Alon further discloses suture lines are connected to a knob (the delivery system connects sutures 500 through the shafts (Figure 41 item 404, 412) which connects to the knob ([0151], [0145])).
Regarding claim 4 the Alon Haug Combination teaches the system of claim 3 substantially as is claimed,
wherein Alon further discloses the knob is configured to control the one or more sutures lines and movement of the one or more loops ([0145], [0152] with reference to the 103 above in which the sutures connect to loops instead of hooks).
Regarding claim 5 the Alon Haug Combination teaches the system of claim 2 substantially as is claimed,
wherein Alon further discloses the one or more suture lines alternate in direction through the loops (Figures 48 and 50 item 500 show the sutures extending both up and down the catheter channel, through one of loop/[engagements structures].) such that the suture lines create tension in the loops (This is stated as a functional limitation (see the explanation above). See also Figure 50 which shows the tension created – the amount of tension on the loop/[engagement structure] being dependent on the amount of force applied by the endovascular cardiologist handling the system).
Regarding claim 7 the Alon Haug Combination teaches the system of claim 2 substantially as is claimed,
wherein Alon further discloses the leaflet assembly includes three valve leaflets (Figure 6) connected to form a Y-shape (Figure 6).
Regarding claim 8 the Alon Haug Combination teaches the system of claim 2 substantially as is claimed,
wherein the leaflet assembly is sewn to the tubular braided frame ([0097], Figures 1 and 6) with a belly stitch angled from a distal outer section of the leaflet assembly towards a middle center of the leaflet assembly (see for example, annotated figure 1 which shows at least one set of stitches that is oriented at an angle from a distal outer section of the leaflet assembly and is oriented diagonally towards the center middle of the leaflet assembly).
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Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alon in view of Haug as is applied above, further in view of Vidlund (US 20150142103 A1).
Regarding claim 6 the Alon Haug Combination teaches the system of claim 1 substantially as is claimed,
wherein Alon further discloses a retrieval system (Figure 38b item 400),
but is silent with regards to the retrieval system comprising a leash within the loops.
However, regarding claim 6 Vidlund teaches a retrieval system which includes a leash incorporated into loops (Figure 13 shows 270 leashing into loops of stent 230). Alon and Vidlund are involved in the same field of endeavor, namely heart valve systems. It would have been obvious to one of ordinary skill at the time the invention was filed to modify the method of the Alon Haug Combination by including a leashed retrieval system such as is taught by Vidlund since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 12/15/25