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 .
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) 1,6-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cartledge et al. (WO 2013/126529). Fig. 5 shows a prosthetic valve actuator attachment status detection system, comprising: at least one actuator 710; a frame 110 of the prosthetic valve movable by the at least one actuator between a radially compressed configuration and a radially expanded configuration (page 27, lines 2-8); and at least one pressure sensor secured to the at least one actuator (page 50, lines 21,22,29-31). Regarding claim 6, Cartledge et al. disclose (page 79) a detection module configured to: receive an output of the at least one pressure sensor; based at least in part on the received output, determine the attachment status of the at least one actuator in relation to the frame; and based at least in part on the attachment status, output an indication of the determined attachment status. Regarding claim 7, Cartledge et al. also disclose (page 51, lines 13-17) the determined attachment status comprises an indication of whether the at least one actuator has detached from the frame. With respect to claim 8, the determined attachment status is an indication of whether the at least one actuator is attached to the frame via release of an indicator, page 51, lines 13-17. Regarding claims 9,18 Cartledge also disclose (page 79) the determined attachment status is an indication of whether the at least one actuator is correctly (green) attached to the frame. With respect to claim 10, Cartledge et al. further disclose (page 50) the detection module is further configured to compare the received output of the at least one pressure sensor to a predetermined pressure value, wherein the determination of the attachment status is based at least in part on an outcome of the comparison. Regarding claim 11, Cartledge et al. show (Fig. 231) the frame 23102 comprises: at least one axially extending post, each of the at least one axially extending post comprising a proximal member and a distal member 23114, 23113 that are axially movable relative to one another to permit the frame to radially expand and/or compress, at least one rod, each associated with a respective one of the at least one axially extending post and rotatably coupled to the proximal member and distal member thereof, wherein a rotation of the at least one rod radially expands and/or radially compresses the frame, the rotation of the at least one rod performed by the at least one actuator (pages 85,86), and wherein the determination of the attachment status of the at least one actuator comprises a determination of whether the at least one actuator is attached to the at least one rod. With respect to claim 12, it can also be seen (Fig. 231) that each of the proximal member and distal member of each of the at least one axially extending post comprise an inner bore, the respective one of the at least one rod extending through the inner bores of the proximal member and distal member. Regarding claims 13,14,16,17 Cartledge et al. show (Figs. 212,213, 234,235) and disclose (page 28, lines 1-7) each of the at least one actuator comprises: a pair of elongated members; and a movable sleeve configured to compress the pair of elongated members such that the compressed pair of elongated members are fastened to a respective one of the at least one rod, wherein when the movable sleeve is moved away from the pair of elongated members the pair of elongated members detach from the respective rod, the determination of the attachment status of the at least one actuator comprising a determination whether the pair of elongated members have detached (pgs 51, 80) from the respective rod or connected/attached (green light, pg 79). With respect to claim 15, Fig. 170 shows the at least one axially extending post comprises a plurality of axially extending posts and the at least one rod comprises a plurality of rods, wherein the at least one actuator comprises a plurality of actuators, the rotation of each of the plurality of rods performed by a respective one of the plurality of actuators, and wherein the determination of the attachment status of the at least one actuator comprises a determination of the attachment status of each of the plurality of actuators, page 69.
Claim(s) 1-3, 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldbert et al. (WO 2021/087196). Figs. 15A-B shows a prosthetic valve actuator attachment status detection system 100, comprising: at least one actuator 188; a frame 140 of the prosthetic valve movable by the at least one actuator between a radially compressed configuration and a radially expanded configuration (paragraph 166); and at least one pressure sensor 180b secured to the at least one actuator (paragraph 260). With respect to claims 2,3, Goldbert et al. discloses (paragraph 83) that the pressure sensor can be an optical pressure sensor or a fiber-optic pressure sensor. Regarding claim 5, Goldbert et al. show (Fig. 15B) a pressure sensor positioned at an edge or outer surface of an actuator.
Claim Rejections - 35 USC § 103
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldbert et al. (WO 2021/087196). Goldbert et al. is explained supra. However, Goldbert et al. did not explicitly disclose the at least one pressure sensor is embedded in the at least one actuator (for the valve). It is noted that Goldbert et al. discloses (paragraphs 129,151) a pressure sensor is embedded in an at least one actuator member of the assembly. It would have been obvious to one of ordinary skill in the art to embed the pressure sensor with the valve actuator in the delivery apparatus for a prosthetic valve by Goldbert et al. since such a modification only involves routine skill in the art and secures the sensor safely from obstruction during movement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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