DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 08/05/2026.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 61/446,972, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The claims appear to be directed to the layout of the different rows of the stent, as shown in Figures 68-72, and the accompanying portions of the specification found at [0173]-[0178] including table 2. These Figures and portions of the specification, including Table 2, are not found in provisional Application No. 61/446,972. Therefore, this application does not receive the benefit of the provisional application filing date of 02/25/2011. Accordingly, the effective filing date of the claimed invention in this application is the filing date of US 13/405,119 (of which this application is a CON of US 17/658,429, which itself is a CON of US 16/353,905, which itself is a CON of US 14/794,690, which itself is a CON of US 13/405,119) which is 02/24/2012.
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 outflow cells including 8-10 sides; exactly ten struts; and exactly ten sides must be shown (i.e., while it is arguable that these features are broadly shown in the Figures, there is no labelling or detailed drawing showing these specific features that make it readily apparent) 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not discuss or describe the outflow cells including 8-10 sides; exactly ten struts; and exactly ten sides. As discussed in the drawing objection above, while it is arguable that these features are broadly shown in the Figures such that this does not constitute new matter, there is nothing in the specification that explains or describes these features.
Claim Objections
The objection to claim(s) 16-17 in the previous Office Action for informalities is hereby withdrawn in view of Applicant’s Amendment.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 2-3, 6-9, 11-13, 14-16, 18-19, and 21-26 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by US 2011/0264203 A1 to Dwork et al. (hereinafter “Dwork”).
Regarding claim 2; Dwork discloses (see abstract; Figs. 1A-2; Examiner's Diagram of Fig. 1A below; and [0030]-[0037]) a prosthetic heart valve (20, see Fig. 1A and [0034]) configured for implantation at a native aortic valve (see [0035]), the prosthetic heart valve comprising: a cylindrical frame (22) comprising an inflow end (30), an outflow end (32), and a plurality of struts forming a plurality of rows of cells (see Fig. 1A and [0031]), wherein each row of the plurality of rows of cells extends circumferentially around the frame (see Fig. 1A), wherein the plurality of rows of cells includes an inflow row comprising inflow cells and disposed at the inflow end of the frame and an outflow row comprising outflow cells and disposed at the outflow end of the frame (see Examiner's Diagram below); and a valve component (24) comprising a plurality of leaflets (26a-b) (see Fig. 1A and [0031]/[0034]), wherein the valve component is disposed within the frame (see Fig. 1A); wherein each of the outflow cells has a larger axial length than each of the inflow cells (see Fig. 1A); wherein each of the outflow cells includes 8 to 10 sides (see Examiner's Diagram below); wherein an inflow end portion of each of the inflow cells comprises a free apex that points toward the inflow end (see Examiner's Diagram below), wherein the free apex comprises an intersection of exactly two struts in a V-shape configuration (see Examiner's Diagram below); and wherein each of the 8 to 10-sided outflow cells is formed without any struts that form free apices that point in a direction toward the outflow end (see Fig. 1A and [0035], any number of posts 40 is considered within the scope of the disclosure, including an embodiment where each outflow end apex comprises a post 40 such that there are no outflow end apexes that are free apices without an associated post 40).
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Dwork further discloses (claim 3) wherein plurality of leaflets forms three angularly spaced commissures that are each sutured to struts of the frame in the outflow row of cells (see [0031] of Dwork incorporating by reference to US 2006/0265056; which discloses at [0053] and Figs. 1A-C three angularly spaced commissures 24 that are sutured to struts of the frame; [0035] of Dwork discloses that that the valve structure can extend the length of the stent frame such that it would be sutured to the outflow cell struts); (claim 6) wherein each of the outflow cells has an outflow end portion, wherein the outflow end portion comprises two interconnected struts in a V-shape (see Examiner's Diagram above); (claim 7) wherein each of the outflow cells has an inflow end portion, an outflow end portion, and two side portions, wherein each of the side portions extends from the inflow end portion to the outflow end portion, wherein each of the side portions comprises at least two struts (see Examiner's Diagram above); (claim 8) wherein each of the side portions comprises exactly three struts (see Examiner's Diagram above); (claim 9) wherein each of the outflow cells includes exactly ten sides (each side indicated by arrow in Examiner's Diagram above showing isolated outflow cell), wherein each of the outflow cells comprises an axis that bisects the respective outflow cell (dashed line in Examiner's Diagram above showing isolated outflow cell) and extends parallel to a longitudinal axis of the frame, wherein each of the ten sides of the respective outflow cell is formed by a strut connected at a first end to a first adjacent strut and connected at a second end to a second adjacent strut, the strut being disposed at a different angle relative to the axis than the first adjacent strut and the second adjacent strut (see Examiner's Diagram above); (claim 11) wherein the frame is plastically deformable from a radially compressed configuration to a radially expanded configuration (see [0032]-[0033]); (claim 12) wherein the frame is configured to be positioned in the radially compressed configuration around an expandable balloon of a delivery apparatus and plastically deformed from the radially compressed configuration to the radially expanded configuration at a location within a patient's body by inflating the expandable balloon (see [0034]/[0067]); (claim 13) further comprising a skirt coupled to the frame (see [0031] of Dwork incorporating by reference to US 2006/0265056; which discloses at [0045] a skirt coupled to the frame); (claim 22) wherein each of the outflow cells includes an outflow portion comprising a non-free apex, wherein the non-free apex is formed by an intersection of two struts in a V-shape with a third strut (post 40) (see Examiner's Diagram above where as per [0035], any number of posts 40 is considered within the scope of the disclosure, including an embodiment where each outflow end apex comprises a post 40 such that there are no outflow end apexes that are free apices without an associated post 40); (claim 23) wherein the third strut comprises an axially extending arm (see Fig. 1A and [0035]-[0036]); and (claim 24) wherein the exactly three struts include a first strut, a second strut, and a third strut, wherein the first strut extends from the outflow end portion to the second strut, the second strut extends from the first strut to the third strut, and the third strut extends from the second strut to the inflow end portion, wherein the first strut has a greater length than each of the second strut and the third strut (see Examiner's Diagram above showing isolated outflow cell).
Regarding claim 14; Dwork discloses(see abstract; Figs. 1A-2; Examiner's Diagram of Fig. 1A below; and [0030]-[0037]) a prosthetic heart valve (20, see Fig. 1A and [0034]) configured for implantation at a native aortic valve (see [0035]), the prosthetic heart valve comprising: a cylindrical frame (22) comprising an inflow end (30), an outflow end (32), and a plurality of struts forming a plurality of rows of cells (see Fig. 1A and [0031]), wherein each row of the plurality of rows of cells extends circumferentially around the frame (see Fig. 1A), wherein the plurality of rows of cells includes an inflow row comprising inflow cells and disposed at the inflow end of the frame and an outflow row comprising ten-sided outflow cells (see Examiner's Diagram above showing isolated outflow cell, each side indicated by arrow) and disposed at the outflow end of the frame (see Examiner's Diagram above) and a valve component (24) comprising a plurality of leaflets (26a-b) (see Fig. 1A and [0031]/[0034]), wherein the valve component is disposed within the frame (see Fig. 1A); wherein each of the ten-sided outflow cells is formed by exactly ten struts (see Examiner's Diagram above showing isolated outflow cell, each strut indicated by arrow); and wherein each of the ten-sided outflow cells includes an outflow end portion comprising a non-free apex (see Fig. 1A and [0035], any number of posts 40 is considered within the scope of the disclosure, including an embodiment where each outflow end apex comprises a post 40 such that there are no outflow end apexes that are free apices without an associated post 40), wherein the non-free apex is formed by an intersection of first and second ones of the exactly ten struts with another strut (post 40) of the frame (see Fig. 1A and Examiner's Diagram above).
Dwork further discloses (claim 15) wherein each of the ten-sided outflow cells has an inflow end portion, the outflow end portion, and two side portions, wherein each of the side portions extends from the inflow end portion to the outflow end portion, wherein each of the side portions comprises exactly three struts (see Examiner's Diagram above showing isolated outflow cell); (claim 16) wherein the inflow end portion comprises exactly two struts in a V-shape configuration; (see Examiner's Diagram above showing isolated outflow cell); and (claim 25) wherein each of the inflow cells includes an inflow portion comprising a free apex that points toward the inflow end, wherein the free apex is formed by exactly two intersecting struts (see Examiner's Diagram above).
Regarding claim 18; Dwork discloses(see abstract; Figs. 1A-2; Examiner's Diagram of Fig. 1A below; and [0030]-[0037]) a prosthetic heart valve (20, see Fig. 1A and [0034]) configured for implantation at a native aortic valve (see [0035]), the prosthetic heart valve comprising: a cylindrical frame (22) comprising an inflow end (30), an outflow end (32), and a plurality of struts forming a plurality of rows of cells (see Fig. 1A and [0031]), wherein each row of the plurality of rows of cells extends circumferentially around the frame (see Fig. 1A), wherein the plurality of rows of cells includes an inflow row comprising inflow cells and disposed at the inflow end of the frame and an outflow row comprising outflow cells and disposed at the outflow end of the frame (see Examiner's Diagram above); and a valve component (24) comprising a plurality of leaflets (26a-b) (see Fig. 1A and [0031]/[0034]), wherein the valve component is disposed within the frame (see Fig. 1A); wherein each of the outflow cells comprises exactly ten sides (see Examiner's Diagram above showing isolated outflow cell, each side indicated by arrow); and wherein each of the outflow cells has an inflow end portion, an outflow end portion, and two side portions (see Examiner's Diagram above showing isolated outflow cell), wherein each of the side portions extends from the inflow end portion to the outflow end portion (see Examiner's Diagram above showing isolated outflow cell), wherein the inflow end portion and the outflow end portion each form two sides of the outflow cell (see Examiner's Diagram above showing isolated outflow cell), wherein each of the side portions forms three sides of the outflow cell and comprises exactly three struts including a first strut, a second strut, and a third strut (see Examiner's Diagram above showing isolated outflow cell); wherein the first strut extends from the outflow end portion to the second strut, the second strut extends from the first strut to the third strut, and the third strut extends from the second strut to the inflow end portion, wherein the first strut has a greater length than each of the second strut and the third strut (see Examiner's Diagram above showing isolated outflow cell).
Dwork further discloses (claim 19) wherein the inflow end portion and the outflow end portion each comprise exactly two struts in a V-shape configuration (see Examiner's Diagram above showing isolated outflow cell); (claim 21) wherein each of the outflow cells comprises an axis that bisects the respective outflow cell (dashed line in Examiner's Diagram above showing isolated outflow cell) and extends parallel to a longitudinal axis of the frame, wherein each of the ten sides of the respective outflow cell is formed by a strut connected at a first end to a first adjacent strut and connected at a second end to a second adjacent strut, the strut being disposed at a different angle relative to the axis than the first adjacent strut and the second adjacent strut (see Examiner's Diagram above); and (claim 26) wherein, for each of the outflow cells, the outflow end portion is asymmetrical relative to the inflow end portion (see Examiner's Diagram above).
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-3, 6-9, 11-13, 14-16, 18-19, and 21-26 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.
With respect to the specification and drawing objections, these objections are maintained. As set forth above, corrections to the specification and drawings would likely not involve new matter because a person of ordinary skill could arbitrarily delineate the drawings/spec. to show 10 sides/struts of the outflow cell, however, there is nothing in the spec. or drawings that defines/explains/shows/guides a person of ordinary skill as to what portions of the outflow cell are delineated as the individual sides/struts other than for the person of ordinary skill to arbitrarily delineate them in any fashion which results in a showing of ten sides/struts. In other words, there is nothing that describes/explains what constitutes a side or a strut – is it a linear portion that is connected with other linear portions, or is it a curved segment connected with other curved segments, etc. Accordingly, the objections are maintained.
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 SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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