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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5, 7-11, and 13-15 have been considered, but are moot in view of the new grounds of rejection.
Claim Rejections - 35 USC § 102
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) 1-5, 7-11, and 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dvorsky et al. (WO 2020/081893 A1; hereinafter “Dvorsky”).
Dvorsky discloses the following regarding claim 1: an implantable prosthetic device, comprising: a hybrid frame (e.g., 100; Fig. 2) movable between a radially compressed configuration and a radially expanded configuration (paras. 0008, 0123), the hybrid frame comprising: a mechanically-expandable first annular sub-frame (outwardly facing elements 108) comprising a plurality of struts pivotably coupled to one another (paras. 0123-0126, 0149-0150), and a self-expanding second annular sub-frame (inwardly facing elements 108) coupled to the first sub-frame (Fig. 2; paras. 0123-0126, 0149-0150); wherein, when the hybrid frame is in the expanded configuration, the second sub-frame is configured to resist radial compression of the frame (paras. 0149-0150).
Dvorsky discloses the following regarding claim 2: the implantable prosthetic device of claim 1, wherein the second sub-frame is disposed radially inwardly of the first sub-frame (e.g., Fig. 2).
Dvorsky discloses the following regarding claim 3: the implantable prosthetic device of claim 1, further comprising one or more expansion mechanisms (e.g., pivot hinge connections) coupled to the first sub-frame (e.g., Figs. 2-4A; paras. 0123-0126, 0133-0135), the expansion mechanisms configured to move the first sub-frame between the radially compressed configuration and the radially expanded configuration (paras. 0123-0126, 0133-0135).
Dvorsky discloses the following regarding claim 4: the implantable prosthetic device of claim 3, wherein each expansion mechanism comprises a first member (e.g., hinge connection openings) coupled to the first sub-frame at a first location (e.g., Figs. 2-4A) and a second member (e.g., hinge connection fasteners) coupled to the first sub-frame at a second location (Figs. 2-4A) spaced apart from the first location (Figs. 2-4A), the second member extending at least partially into the first member (Figs. 2-4A; paras. 0123-0126, 0133-0135).
Dvorsky discloses the following regarding claim 5: the implantable prosthetic device of claim 3, wherein the first and second sub-frames are coupled to one another via the one or more expansion mechanisms (Figs. 2-4A; paras. 0123-0126, 0133-0135).
Dvorsky discloses the following regarding claim 7: the implantable prosthetic device of claim 1, wherein the second sub-frame exerts a radially outwardly directed force on the first sub-frame to resist radial compression of the first sub-frame (paras. 0123-0126, 0149-0150).
Dvorsky discloses the following regarding claim 8: the implantable prosthetic device of claim 1, further comprising a valvular structure (para. 0013) including a plurality of leaflets (22), the valvular structure coupled to the second sub-frame (paras. 0013, 0149).
Dvorsky discloses the following regarding claim 9: the implantable prosthetic device of claim 3, further comprising a valvular structure (para. 0013) including a plurality of leaflets (22), the valvular structure coupled to the one or more expansion mechanisms (paras. 0123-0126, 0149-0150).
Dvorsky discloses the following regarding claim 10: an implantable prosthetic device, comprising: a radially compressible and expandable frame (e.g., 100) (paras. 0008, 0123), the frame comprising: a mechanically expandable first annular sub-frame (outwardly facing elements 108) comprising one or more expansion mechanisms (pivot hinge connections) configured to move the first sub-frame between a radially compressed configuration and a radially expanded configuration (e.g., Figs. 2-4A; paras. 0123-0126, 0133-0135, 0149-0150), and a self-expanding second annular sub-frame (inwardly facing elements 108) coupled to the first sub-frame (Fig. 2), the second sub-frame configured to exert a radially outwardly directed force on the first sub-frame to prevent radial compression of the frame from the expanded configuration (paras. 0123-0126, 0149-0150).
Dvorsky discloses the following regarding claim 11: the implantable prosthetic device of claim 10, wherein the first and second sub-frames are coupled to one another via the one or more expansion mechanisms (Figs. 2-4A; paras. 0123-0126, 0133-0135).
Dvorsky discloses the following regarding claim 13: the implantable prosthetic device of claim 10, further comprising a valvular structure (para. 0013) including a plurality of leaflets (22), the valvular structure coupled to the second sub-frame (paras. 0013, 0149).
Dvorsky discloses the following regarding claim 14: the implantable prosthetic device of claim 10, wherein the second sub-frame is disposed radially inwardly of the first sub-frame (e.g., Fig. 2).
Dvorsky discloses the following regarding claim 15: the implantable prosthetic device of claim 10, wherein portions of the second sub-frame are disposed radially inwardly of the first sub-frame (at the non-flared portions of the device) (paras. 0017, 0142-0144, 0210-0211) and other portions of the second sub-frame are disposed radially outwardly of the first sub-frame (portions of the second sub-frame at the flared portions of the stent are positioned radially outwardly relative the non-flared portions of the first sub-frame) (e.g., Figs. 9, 12; paras. 0017, 0142-0144, 0210-0211).
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 Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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