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 .
Allowable Subject Matter
Claims 7, 10-11 and 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claim 7, the prior art Goldbert et al. fails to teach nor render obvious wherein 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 whether the at least one actuator has detached from the at least one rod comprising a determination whether the pair of elongated members have detached from the respective rod.
Regarding Claim 10, the prior art Goldbert et al. fails to teach nor render obvious wherein the determination whether the plurality of actuators have detached from the frame is based at least in part on detecting a plurality of predetermined mechanical wave signals, wherein the at least one mechanical wave sensor comprises a microphone array, and wherein, based at least in part on the output of the mechanical wave sensor, the detection module is further configured to: identify which of the plurality of actuators have detached from the frame; and output an indication of the identified actuators.
11. The system of claim 4, wherein the detection module is further configured to: based at least in part on the received output, determine whether the at least one actuator has broken; and based at least in part on the determination, output an indication of whether the at least one actuator has broken.
Regarding Claim 18, the prior art Goldbert et al. fails to teach nor render obvious wherein the at least one mechanical wave sensor is attachable to the skin of a patient. Claim 19 depends from claim 18.
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim(s) 1-3, 12-17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Goldbert et al. WO 2021/087196 A1.
Regarding Claim 1, Goldbert et al. discloses a prosthetic valve actuator detachment detection system as seen in Figures 9s-9H, 15A-16B, comprising: at least one actuator 156; a frame 140 of the prosthetic valve movable by the at least one actuator 102 between a radially compressed configuration and a radially expanded configuration (paragraph [0162-0163], [0209]); and at least one mechanical wave sensor 1810a, 180b (paragraphs [0325], [0333], [0440-0441]).
Regarding Claim 2, Goldbert et al. discloses wherein the at least one mechanical wave sensor is a sound sensor (paragraphs [0385], [0438]).
Regarding Claim 3, Goldbert et al. discloses wherein the at least one mechanical wave sensor is a vibration sensor (paragraphs [0384], [0445]).
Regarding Claim 12, Goldbert et al. discloses wherein the at least one mechanical wave sensor 180b is attached to the at least one actuator 156 (as seen in Figure 9D and paragraph [0278]).
Regarding Claim 13, Goldbert et al. discloses wherein the at least one mechanical wave sensor 180b is attached to the frame (via the support sleeve 157 around the actuating member 156/155, the sensor 180b is indirectly attached to the frame, see Figs 9D and 15B and paragraph [0278]).
Regarding Claim 14, Goldbert et al. discloses a delivery shaft, the at least one actuator supported by the delivery shaft, wherein the at least one mechanical wave sensor is attached to the delivery shaft.
Regarding Claim 15, Goldbert et al. discloses further comprising a nosecone shaft 126 extending through the frame (as seen in Figures 15A-15B), wherein the at least one mechanical wave sensor 180a is attached to the nosecone shaft 126 (paragraphs [0212-0214]).
Regarding Claim 16, Goldbert et al. discloses a handle 110; a sensor shaft 192 extending from the handle 110 (paragraph [0331]), the mechanical wave sensor 180A secured to the sensor shaft 188; and a delivery shaft 18 coupled to the handle, the at least one actuator and the sensor shaft supported by the delivery shaft 188, wherein the at least one mechanical wave sensor 180A extends distally from the delivery shaft 188 (as seen in Figure 15B).
Regarding Claim 17, Goldbert et al. discloses a handle 110; a sensor shaft 223 the at least one mechanical wave sensor 180A secured to the sensor shaft 223 (paragraph [0227-0228]) ; and a delivery shaft 122 coupled to the handle 110, the at least one actuator supported by the delivery shaft and the sensor shaft not supported by the delivery shaft (as seen in Figures 2 and 5C, 7A-7D and paragraphs [0163], [0221]).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-6 and 8-9 are is/are rejected under 35 U.S.C. 103 as being obvious over Goldbert et al. WO 2021/087196 A1 in view of Andreas et al. U.S. Publication 2005/0149159 A1
Regarding Claim 4, 9, Goldbert et al. does not disclose a detection module configured to: receive an output of the at least one mechanical wave sensor; based at least in part on the received output, determine whether the at least one actuator has detached from the frame; and based at least in part on the determination, output an indication of whether the at least one actuator has detached from the frame, wherein the determination whether the actuator has detached from the frame is based at least in part on detecting whether one or more predetermined mechanical wave signals are present in the output of the at least one mechanical wave sensor. Andreas et al. teaches as prosthetic valve system in the same field of endeavor comprising an actuator 54, a frame 46 (paragraph [0072]) and a sensor 180 which detects the length of the deployable portion of the stent or the length of the stent that remains undeployed, and an indicator such as a display or other output means associated with the sensor for providing visual, audible or tactile indicating the audible sound from the actuator to indicate the distance in which the actuator has moved the frame (paragraph [0020]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Goldbert’s system to further include an indicator/detection module configured to receive output from a sensor based on the audible sound emitted by the actuator as taught by Andreas for the purpose of displaying or providing output of the length of the stent that has been expanded or undeployed.
Regarding Claim 5, Goldbert et al. discloses wherein the frame 140’ comprises: at least one axially extending post 156, each of the at least one axially extending post 156 comprising a proximal member and a distal member 159 that are axially movable relative to one another to permit the frame to radially expand and/or compress (paragraph [0199-0200]), at least one rod 160, each associated with a respective one of the at least one axially extending post 156 and rotatably coupled to the proximal member and distal member thereof (as seen in Figure 9D and paragraphs [0198-0200]), wherein a rotation of the at least one rod 160 radially expands and/or radially compresses the frame, the rotation of the at least one rod 160 based at least in part on the at least one actuator, and wherein the determination whether the at least one actuator has detached from the frame comprises a determination whether the at least one actuator has detached from the at least one rod (paragraphs [0198-0202]).
Regarding Claim 6, Goldbert et al. discloses wherein each of the proximal member and the distal member of each of the at least one axially extending post comprises an inner bore, the respective one of the at least one rod 160 extending through the inner bores of the proximal member and distal member (threaded bore couples the rod 160, see paragraph [0199]).
Regarding Claim 8, Goldbert et al. discloses wherein the at least one axially extending post comprises a plurality of axially extending posts 156 and the at least one rod comprises a plurality of rods 160, wherein the at least one actuator 156 comprises a plurality of actuators, the rotation of each of the plurality of rods 160 based at least in part on a respective one of the plurality of actuators, and wherein the determination whether the at least one actuator has detached from the frame comprises a determination whether all of the plurality of actuators have detached from the frame (paragraphs [0198-0202]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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