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 .
Election/Restrictions
Applicant’s election without traverse of Species C in the reply filed on 10/21/2025 is acknowledged. Claims 6, 12, and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species embodiments, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/21/2025. The requirement is still deemed proper and is therefore made FINAL.
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 Maimon et al. (Pub. No.: US 2018/0153689 A1; hereinafter “Maimon”).
Maimon discloses the following regarding claim 1: an implantable prosthetic device, comprising: a hybrid frame (e.g., 412, 604) (Figs. 14, 28) movable between a radially compressed configuration and a radially expanded configuration (paras. 0171, 0200, 0233), the hybrid frame comprising: a mechanically-expandable first sub-frame (outwardly positioned upper and lower struts of elements 412, 604) comprising a plurality of struts pivotably coupled to one another (paras. 0169-0173, 0233-0235), and a self-expanding second sub-frame (inwardly positioned central struts made of nitinol) coupled to the first sub-frame (Figs. 14, 28; para. 0118); wherein, when the hybrid frame is in the expanded configuration, the second sub-frame is configured to resist radial compression of the frame (paras. 0171-0172, 0207-0208; upon locking the frame at its desired diameter).
Maimon 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 (Figs. 14, 28).
Maimon discloses the following regarding claim 3: the implantable prosthetic device of claim 1, further comprising one or more expansion mechanisms (e.g., 410, 800) coupled to the first sub-frame (Figs. 14, 28), the expansion mechanisms configured to move the first sub-frame between the radially compressed configuration and the radially expanded configuration (paras. 0171-0172, 0233-0235).
Maimon discloses the following regarding claim 4: the implantable prosthetic device of claim 3, wherein each expansion mechanism comprises a first member (e.g., upper element 424, 810) coupled to the first sub-frame at a first location (upper location) (Figs. 14, 28, 29C) and a second member (e.g., lower element 424, 814) coupled to the first sub-frame at a second location (lower location) spaced apart from the first location (Figs. 14, 28, 29C), the second member extending at least partially into the first member (via elements 416, 418, 812) (Figs. 14, 28, 29C).
Maimon 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. 14, 28, 29C).
Maimon 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. 0171-0172, 0207-0208, 0233-0235).
Maimon discloses the following regarding claim 8: the implantable prosthetic device of claim 1, further comprising a valvular structure (e.g., 48, 1804) including a plurality of leaflets (para. 0125), the valvular structure coupled to the second sub-frame (Figs. 2, 51).
Maimon discloses the following regarding claim 9: the implantable prosthetic device of claim 3, further comprising a valvular structure (e.g., 48, 1804) including a plurality of leaflets (para. 0125), the valvular structure coupled to the one or more expansion mechanisms (Figs. 2, 51, where coupling can occur via intermediary elements).
Maimon discloses the following regarding claim 10: an implantable prosthetic device, comprising: a radially compressible and expandable frame (e.g., 412, 604) (Figs. 14, 28; paras. 0171, 0200, 0233), the frame comprising: a mechanically expandable first sub-frame (upper and lower struts) comprising one or more expansion mechanisms (e.g., 410, 800) configured to move the first sub-frame between a radially compressed configuration and a radially expanded configuration (paras. 0171-0172, 0233-0235), and a self-expanding second sub-frame (central strut elements made of nitinol) coupled to the first sub-frame (Figs. 14, 28; para. 0118), 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. 0171-0172, 0207-0208).
Maimon 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. 14, 28).
Maimon discloses the following regarding claim 13: the implantable prosthetic device of claim 10, further comprising a valvular structure (e.g., 48, 1804) including a plurality of leaflets (para. 0125), the valvular structure coupled to the second sub-frame (Figs. 2, 51).
Maimon 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 (at inwardly positioned central struts) (Figs. 14, 28).
Maimon 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 inwardly positioned central struts) (Figs. 14, 28) and other portions of the second sub-frame are disposed radially outwardly of the first sub-frame (at outwardly positioned central struts) (Figs. 14, 28).
Conclusion
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANN HU/Primary Examiner, Art Unit 3774