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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: outer sleeve sub-assembly 301, intermediate actuator sub-assembly 303, and inner engagement sub-assembly 305. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 12 is objected to because of the following informalities: claim 12 states, “…internal threads disposed on a socket of the of the distal end portion” in line 2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the limitation "the threads of the threaded portion" in line 3. There is insufficient antecedent basis for this limitation in the claim. Further, by stating “the threads of the threaded portion” when claiming two separate threaded regions of the device, it is unclear which threaded portion is being referred to throughout the claim. Further clarification is required.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Maimon et al. (US 2018/0153689 A1), “Maimon” in view of Cohen et al., (US 2019/0060057 A1), “Cohen”.
Regarding claim 1, Maimon teaches a delivery apparatus for implanting a prosthetic valve (Fig. 18, prosthetic valve delivery assembly 600) comprising a mechanically actuatable frame (Fig. 18, frame 604), the delivery apparatus comprising: at least one actuation assembly configured to form a releasable connection the frame (Fig. 18, locking tool 611), the actuation assembly comprising: an outer sleeve sub-assembly (Fig. 25D, shaft 634) comprising a sleeve head configured to engage opposing surfaces of an end portion of the frame (Fig. 25C, tool 632); an actuation sub-assembly extending through the outer sleeve sub-assembly (Fig. 25C, inner shaft 636 extends coaxially through outer shaft 634), the actuation sub-assembly (Fig. 25C, inner shaft 636) comprising an actuation head comprising one or more planar surfaces configured to engage one or more complementary planar surfaces of the head of the actuator member (Figs. 25B-C, inner shaft 636 of tool 632 forms flat surfaces which mate with screw head 630); and an engagement sub-assembly extending through the outer sleeve sub-assembly (Figs. 25B-C, attachment member 638), the engagement sub-assembly comprising an engagement head comprising a threaded portion configured to form a releasable threaded connection with a threaded portion of the head of the actuator member (Figs. 25B-C, attachment member 638 comprises external threads 640 to releasably connect with screw head 630 of locking screw 624 [0211]), but fails to teach the frame comprising at least one actuator member configured to be rotated, via rotation of a head thereof, to radially expand and compress the frame.
Cohen teaches a prosthetic valve delivery apparatus wherein the frame comprises at least one actuator member configured to be rotated, via rotation of a head thereof, to radially expand and compress the frame (Fig. 2, frame 102 comprises screw 132 wherein rotation of screw 132 causes sleeve 134 to actuate toward or away from anchor member 136 to radially expand or compress the frame [0050-0051]). Cohen discloses that each screw comprises an attachment member which forms a releasable connection with a corresponding drive shaft of a delivery apparatus [0052]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the actuator member taught by Cohen with the delivery apparatus taught by Maimon in order to simplify deployment of the valve by providing an easily detachable actuator.
Regarding claim 2, Maimon teaches wherein the sleeve head comprises a first support extension configured to engage a first surface of the opposing surfaces of the end portion of the frame (Fig. 25D, left side of square shape that is tool 632 of outer shaft 634), and a second support extension configured to engage a second surface of the opposing surfaces of the end portion of the frame (Fig. 25D, right side of square shape that is tool 632 of outer shaft 634); and wherein the first and second support extensions are configured to, when the connection between the actuation assembly and the frame is formed, brace the end portion of the frame therebetween (Fig. 24A, tool 632 engages with screw head 630 of locking mechanism 610 at bottom of frame 604).
Regarding claim 3, Maimon teaches wherein the engagement sub-assembly extends coaxially through the actuation sub-assembly such that at least a portion of the engagement head extends into at least a portion of the actuation head (Figs. 25B-C, attachment member 638 coaxially mates with inner shaft 636 and is threaded into screw head 630), wherein the engagement head is rotatable relative to the actuation head (Figs. 25B-C, inner shaft 636 is rotated in a first direction to screw attachment member 638 into screw head 630).
Regarding claim 4, Maimon teaches wherein the actuation sub-assembly extends coaxially through the engagement sub-assembly such that at least a portion of the actuation head extends into at least a portion of the engagement head (Figs. 25B-C, attachment member 638 coaxially mates with inner shaft 636 and is threaded into screw head 630), wherein the engagement head is rotatable relative to the actuation head (Figs. 25B-C, inner shaft 636 is rotated in a first direction to screw attachment member 638 into screw head 630).
Regarding claim 5, Maimon teaches a delivery apparatus for implanting a prosthetic valve (Fig. 18, prosthetic valve delivery assembly 600) comprising a mechanically actuatable frame (Fig. 18, frame 604), the delivery apparatus comprising: at least one actuation assembly configured to be releasably coupled to the frame (Fig. 18, locking tool 611), the actuation assembly comprising: a first member comprising threads disposed on a distal end portion thereof that are configured to form a first releasable connection with a threaded portion of the head of the actuator member (Figs. 25B-C, attachment member 638 comprises external threads 640 to releasably connect with screw head 630 of locking screw 624 [0211]); and a second member that is coaxial with the first member and has distal end portion configured to form a second releasable connection with the head of the actuator member (Figs. 25B-C, inner shaft 636 of tool 632 forms flat surfaces which mate with attachment member 638 and further, screw head 630), wherein the first member and the second member are rotatable together to rotate the actuator member and expand the prosthetic valve (Figs. 24A-D, locking mechanism 610 can be actuated to lock the frame 604 in the desired radially expanded size [0207]), but fails to teach wherein the frame comprises at least one actuator member configured to be rotated, via rotation of a head thereof, to radially expand and compress the frame.
Cohen teaches a prosthetic valve delivery apparatus wherein the frame comprises at least one actuator member configured to be rotated, via rotation of a head thereof, to radially expand and compress the frame (Fig. 2, rotation of screw 132 causes sleeve 134 to actuate toward or away from anchor member 136 to radially expand or compress the frame [0050-0051]). Cohen discloses that each screw comprises an attachment member which forms a releasable connection with a corresponding drive shaft of a delivery apparatus [0052]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the actuator member taught by Cohen with the delivery apparatus taught by Maimon in order to simplify deployment of the valve by providing an easily detachable actuator.
Regarding claim 6, Maimon teaches wherein the actuation assembly further comprises a third member that is coaxial with and disposed around each of the first member and the second member (Fig. 25D, shaft 634 further comprising tool 632), wherein the first member and the second member are rotatable relative to the third member (Figs. 25B-C, inner shaft 636 is rotated in a first direction to screw attachment member 638 into screw head 630 without rotation of shaft 634).
Regarding claim 7, Maimon teaches wherein the distal end portion of the second member has a shape that is configured to mate with and fit within or around a complementary-shaped portion of the head of the actuator member to form the second releasable connection (Figs. 25B-C, inner shaft 636 complimentarily mates with attachment member 638 of tool 632 to further complimentarily mate with screw head 630).
Regarding claim 8, Maimon teaches wherein the first member extends coaxially through the second member (Figs. 25B-C, inner shaft 636 and attachment member 638 are coaxially engaged [0211]).
Regarding claim 9, Maimon teaches wherein the threads of the first member are external threads that are configured to mate with internal threads of a first socket of the head of the actuator member (Figs. 25B-C, attachment member 638 comprises external threads 640 which mate with internal threads 642 of screw head 630).
Regarding claim 10, Maimon teaches wherein the distal end portion of the second member comprises a second socket defining an interior surface comprising one or more first facets (Figs. 25B-C, inner shaft 636 engages with attachment member 638 within tool 632 to form an interior opening which allows for the movement of attachment member 638), wherein the one or more first facets have a complementary configuration to one or more second facets on an exterior surface of the head of the actuator member (Figs. 25B-C, edges of screw head 630 compliment that open space formed within tool 632 by inner shaft 636 and attachment member 638).
Regarding claim 11, Maimon teaches wherein the second member extends coaxially through the first member (Fig. 25B, inner shaft 636 coaxially mates with attachment member 638).
Regarding claim 12, Maimon teaches wherein the threads of the first member are internal threads disposed on a socket of the of the distal end portion of the first member that are configured to mate with external threads on a threaded portion of the head of the actuator member (Figs. 25B-C, attachment member 638 comprises external threads 640, positioned within tool 632, which mate with internal threads 642 of screw head 630).
Regarding claim 13, Maimon teaches wherein the distal end portion of the second member is an actuation head having a cross-section shaped to fit within a complementary shaped socket of the head of the actuator member (Fig. 25D, screw head 630 and tool head 632 comprise complimentary square or rectangular shapes [0202-0210]).
Regarding claim 14, Maimon teaches wherein the cross-section of the actuation head of the second member is square-shaped (Fig. 25D, screw head 630 and tool head 632 comprise complimentary square or rectangular shapes [0202-0210]).
Regarding claim 15, Maimon teaches a system comprising: a prosthetic valve comprising a mechanically actuatable frame (Fig. 18, prosthetic valve 602 comprises frame 604), the mechanically actuatable frame comprising at least one actuator member (Fig. 18, locking mechanism 610); and a delivery apparatus comprising at least one actuation assembly (Fig. 18, locking tool 611), the actuation assembly comprising: a first member comprising a threaded socket at its distal end that is configured to engage with external threads on a threaded portion of the head of the actuator member (Figs. 25B-C, attachment member 638 comprises external threads 640 to releasably connect with screw head 630 of locking screw 624 [0211]); and a second member disposed coaxially within the first member (Fig. 25C, inner shaft 636 is coaxially placed within outer shaft 634 and tool 632 which comprises attachment member 638), the second member comprising an actuation head at its distal end that is shaped to mate with and fit within a socket of the head of the actuator member (Figs. 25B-C, inner shaft 636 of tool 632 forms flat surfaces with tool 632 which mate with screw head 630), wherein the first member and the second member are rotatable together to rotate the actuator member and expand the prosthetic valve (Figs. 24A-D, locking mechanism 610 can be actuated to lock the frame 604 in the desired radially expanded size [0207]), but fails to teach wherein the actuator member is configured to be rotated, via rotation of a head thereof, to radially expand or compress the frame.
Cohen teaches a prosthetic valve delivery apparatus wherein the actuator member is configured to be rotated, via rotation of a head thereof, to radially expand or compress the frame (Fig. 2, rotation of screw 132 causes sleeve 134 to actuate toward or away from anchor member 136 to radially expand or compress the frame [0050-0051]). Cohen discloses that each screw comprises an attachment member which forms a releasable connection with a corresponding drive shaft of a delivery apparatus [0052]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the actuator member taught by Cohen with the delivery apparatus taught by Maimon in order to simplify deployment of the valve by providing an easily detachable actuator.
Regarding claim 16, Maimon teaches wherein the actuation assembly is movable between an engaged position and disengaged position with the frame (Figs. 24A-D), wherein in the engaged position the threaded socket of the first member is engaged with the external threads on the threaded portion of the head of the actuator member and the actuation head of the second member is disposed within and engaged with the socket of the head of the actuator member (Fig. 25C, when engaged, internal threads 642 of screw head 630 are mated with external threads 640 of attachment member 638, and screw head 630 is within tool 632), and wherein in the engaged position the first member and the second member are rotatable together to rotate the actuator member and radially expand or compress the frame (Figs. 24A-D, locking mechanism 610 can be actuated to lock the frame 604 in the desired radially expanded size [0207]).
Regarding claim 17, Maimon teaches wherein the socket of the head of the actuator member extends through the threaded portion of the head of the actuator member such that the threads of the threaded portion are external to the socket of the head of the actuator (Fig. 25C, internal threads 642 of screw head 630 extend around threads 640 of attachment member 638).
Regarding claim 18, Maimon teaches wherein the actuation head has a cross-sectional shape that is complementary to a cross-sectional shape of the socket of the head of the actuator member (Fig. 25D, screw head 630 and tool head 632 comprise complimentary square or rectangular shapes [0202-0210]).
Regarding claim 19, Maimon teaches wherein the actuation assembly further comprises an outer, third member comprising a pair of support extensions configured to engage with a post of the frame (Fig. 25D, shaft 634 further comprising tool 632 which is formed to comprise edges that mate with screw head 630 attached to frame 604).
Regarding claim 20, Maimon teaches wherein the first member and the second member are rotatable relative to the third member (Figs. 25B-C, inner shaft 636 is rotated in a first direction to screw attachment member 638 into screw head 630 without rotation of shaft 634).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO 2021/146101.
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/G.G.R./ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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