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 .
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.
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20180153689 A1 (hereafter --Maimon--).
Regarding Claim 1, Maimon discloses an implantable device comprising: a radially expandable frame configured to move between a radially compressed state and a radially expanded state (see Abstract), the frame (412) comprising a plurality of struts (see annotated struts in Figure 14 below, see also paragraph [0173]), at least one actuator mechanism (440, 442) configured to compress and expand the frame (see paragraph [0176], see also annotated actuation mechanism in Figure 14 below), and at least one locking mechanism (410) coupled to the actuator mechanism (see paragraph [0175]); wherein a first strut and a second strut of the plurality of struts are pivotably coupled to one another at a common junction (434 pivots) and configured to move toward one another as the frame is compressed and away from one another as the frame is expanded (see paragraph [0173]); wherein the first and second struts have first and second locking features (470) that extend from longitudinal side edges of the first and second struts, respectively (see paragraph [0180], in which the entire 410 extends from side edges struts); wherein the locking mechanism (410) comprises a locking member (478, 472) configured to extend between and engage the first and second locking features when the frame is expanded to retain the frame in the radially expanded state (see paragraph [0185]).
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Regarding Claim 2, Maimon discloses the implantable device of claim 1, wherein the locking member is configured to move between a locked position in which the locking member extends between and engages the first and second locking features and an unlocked position in which the locking member allows the first strut and the second strut to move toward one another and the frame to move from the expanded state into the compressed state (see paragraphs [0181] and [0185]).
Regarding Claim 3, Maimon discloses the implantable device of claim 2, further comprising a release member releasably coupled to the locking member and configured to move the locking member from the locked position to the unlocked position (see paragraph [0181]).
Regarding Claim 4, Maimon discloses the implantable device of claim 1, wherein the locking mechanism further comprises a biasing member (staff of 472 being bendable) configured to bias the locking member (472, 478) in a first direction to engage the first and second locking features (see paragraph [0181] denoting that the locking member can be biased radially inward).
Regarding Claim 5, Maimon discloses the implantable device of claim 1, further comprising a release member (444) releasably coupled to the locking member and configured to move the locking member from the locked position to the unlocked position (see paragraph [0181]), wherein the locking mechanism further comprises a biasing member (bendable body of 472) configured to bias the locking member (472, 478) in a first direction to engage the first and second locking features (see paragraph [0181]), and wherein the release member is configured to retract the locking member in a second direction opposite the first direction of the bias of the locking member to move the locking member to the unlocked position (see paragraphs [0181] and [0185]).
Regarding Claim 6, Maimon discloses the implantable device of claim 1, wherein the locking member is configured to extend between and engage the first and second locking features when the frame is in a first radially expanded state and when the frame is in a second radially expanded state (see paragraphs [0181] and [0185] denoting that the release member can be retracted to return the implant to its locked position, and that the release member can be disposed between the 416 and 418 to allow the diameter of the stent to expand more).
Regarding Claim 7, Maimon discloses the implantable device of claim 6, wherein the frame has a first diameter in the first radially expanded state and a second diameter in the second radially expanded state (see paragraphs [0181] and [0185] denoting that the release member can be retracted to return the implant to its locked position, and that the release member can be disposed between the 416 and 418 to allow the diameter of the stent to expand more, the device is capable of being expanded at a diameter, locked, then unlocked and expanded to a larger diameter, then locked again).
Regarding Claim 8, Maimon discloses the implantable device of claim 7, wherein the second diameter of the frame is greater than the first diameter of the frame (see paragraphs [0181] and [0185] denoting that the release member can be retracted to return the implant to its locked position, and that the release member can be disposed between the 416 and 418 to allow the diameter of the stent to expand more, the device is capable of being expanded at a diameter, locked, then unlocked and expanded to a larger diameter, then locked again).
Regarding Claim 9, Maimon discloses the implantable device of claim 1, wherein the locking member extends radially from an inner surface of the frame to an outer surface of the frame (see paragraph [0181 denoting that the locking member 472 is made of material that is bendable, so the locking member is capable of “extending radially from an inner surface of the frame to an outer surface of the frame).
Regarding Claim 10, Maimon discloses the implantable device of claim 1, wherein the first and second locking features are located proximate the common junction of the first and second struts (see annotated pivots being the common junctions and the first and second struts in Figure 14 above).
Regarding Claim 11, Maimon discloses the implantable device of claim 1, wherein the first and second locking features are integrally formed with their respective struts (see annotated locking mechanisms having the locking features 470 within them being connected to the first and second struts, forming an integral structure that makes up the frame with the locking member and struts).
Regarding Claim 12, Maimon discloses the implantable device of claim 1, wherein the at least one actuator mechanism comprises a plurality of actuator mechanisms (440, 442) and the at least one locking mechanism comprises a plurality of locking mechanisms (see paragraph [0177] denoting that there are multiple locking units 410), each locking mechanism being coupled to a respective actuator mechanism (see paragraphs [0177], [0178], and [0179]).
Regarding Claim 13, Maimon discloses an implantable device comprising: a radially expandable frame configured to move between a radially compressed state and a radially expanded state (see Abstract), the frame (412) comprising: a plurality of inner and outer struts forming an inflow end and an outflow end (see annotated inflow end, outflow end, inner struts, and outer struts in Figure 14 below, see also paragraph [0173]), an inner strut having an inner locking feature (416) circumferentially extending from a longitudinal side edge of the inner strut (see annotated inner struts and 416 in Figure 14 below) and an outer strut pivotably coupled to (via 434, see paragraph [0173]) and adjacent the inner strut (see annotated outer struts and inner struts in Figure 14 below) having an outer locking feature (418) circumferentially extending from a longitudinal side edge of the outer strut (see annotated outer locking feature 418 and outer struts in Figure 14 below); at least one expansion mechanism (440, 442) configured to compress and expand the frame (see paragraph [0176], see also annotated expansion mechanism in Figure 14 below); and a locking mechanism (410) coupled to the expansion mechanism and comprising a wedge member (478) configured to engage the inner and outer locking features (see paragraph [0185]) and a biasing member (bendable body 472) configured to bias the wedge member between the inner and outer locking features as the frame is radially expanded (see paragraph [0181]); wherein the inner and outer struts are configured to move toward one another and overlap as the frame is radially compressed and move away from one another and circumferentially separate as the frame is radially expanded (see paragraph [0173]), wherein the wedge member engages an end portion of at least one of the inner and outer locking features when the frame is in the radially compressed state (see paragraphs [0180] and [0181], denoting the wedge member 478 is connected to outer member 418 through biasing member 472, therefore “engaging” the outer member through that connection), and extends and wedges between the inner and outer locking features as the frame is radially expanded such that the inner and outer struts and frame are retained in the radially expanded state (see paragraphs [0180] and [0181], the wedge member wedges into the recesses in the inner member 470).
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Regarding Claim 14, Maimon discloses the implantable device of claim 13, wherein as the frame is continually expanded, the wedge member extends and wedges further between the inner and outer locking features such that the frame is retained in a relatively greater radially expanded state (see paragraphs [0180] and [0181], the wedge member wedges into the recesses in the inner member 470 once the release portion 444 is moved proximally, the “further” wedging being interpreted to mean the wedge member going into a different recess 470 that would be representative of a “bigger” diameter).
Regarding Claim 15, Maimon discloses the implantable device of claim 13, wherein the locking mechanism is configured to retain the frame in two or more successive radially expanded states (see paragraphs [0181] and [0185] denoting that the release member can be retracted to return the implant to its locked position, and that the release member can be disposed between the 416 and 418 to allow the diameter of the stent to expand more, the device is capable of being expanded at a diameter, locked, then unlocked and expanded to a larger diameter, then locked again).
Regarding Claim 16, Maimon discloses the implantable device of claim 15, wherein a diameter of the frame progressively increases with each successive radially expanded state (see paragraphs [0180] and [0181], the wedge member wedges into the recesses in the inner member 470 once the release portion 444 is moved proximally, the “further” wedging being interpreted to mean the wedge member going into a different recess 470 that would be representative of a “bigger” diameter).
Regarding Claim 17, Maimon discloses the implantable device of claim 13, wherein the wedge member and biasing member are coaxially aligned (see paragraphs [0180] and [0181] describing the connection between components 478 and 472, see also Figure 16D below).
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Regarding Claim 18, Maimon discloses the implantable device of claim 13, wherein the locking mechanism further comprising a support member extending outwardly from the expansion mechanism and coupled to the wedge member (see annotated support member 490 in Figure 16D above), the biasing member being situated between the support member and the wedge member (490 being the outer rigid sleeve, connected to the wedge member through the sleeves connection with component 418, and the connection between the biasing member and 418).
Regarding Claim 19, Maimon discloses the implantable device of claim 13, wherein the inner and outer locking features each comprise one or more circumferentially extending teeth (see annotated circumferentially extending teeth in Figure 16D above).
Regarding Claim 14, Maimon discloses a method comprising: inserting a distal end of a delivery apparatus (18) into a vasculature of a patient (see paragraph [0183]), the delivery apparatus releasably coupled to a prosthetic heart valve (see paragraph [0183]) comprising a radially expandable frame configured to move between a radially compressed state and a radially expanded state (see paragraph [0184]), the frame comprising a plurality of struts (see annotated struts in Figure 14 below), at least one expansion mechanism (440, 442) (see paragraph [0176]) configured to compress and expand the frame (see paragraph [0176], see also annotated actuation mechanism in Figure 14 below); and at least one locking mechanism (410) coupled to the expansion mechanism and comprising a locking member (472, 478) (see paragraph [0175]); wherein a first strut comprises a first circumferentially extending locking feature (416) and a second strut coupled to and adjacent the first strut comprises a second circumferentially extending locking feature (418) (see annotated struts and locking features in Figure 14 below); advancing the prosthetic heart valve to a selected implantation location (see paragraph [0183]); expanding the frame of the prosthetic heart valve (see paragraph [0183]); and wedging the locking member of the locking mechanism between the first and second locking features (see paragraphs [0181] and [0185] denoting that the release member can be retracted to return the implant to its locked position) wherein engagement between the locking member and the first and second locking features prevents the struts from moving in a first direction to compress the frame and permits the struts to move in a second direction radially expand the frame (see paragraph [0185]).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20200390547 A1: This reference discloses a delivery apparatus and a frame with an actuation/expansion mechanism and a locking mechanism.
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/PARIS MARIE BLASS/
Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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