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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63046841, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
In regards to claim 1, applicant recites: “a membrane spacing element configured to dispose the flexible membranes in the intermediate configuration in response to a substantial absence of blood flow between the native leaflets, the membrane spacing element configured to permit the flexible membranes to move from the intermediate configuration to the closed configuration in response to blood flow in the first direction and to move from the intermediate configuration to the open configuration in response to blood flow in the second direction.” Limitation not disclosed in provisional application.
In regards to claim 15, applicant recites: “a support frame coupled to the occluder and coupleable to the clip to secure the support frame and the occluder in the native valve with the occluder disposed in the flow control portion of the native valve, the support frame configured to be adjustable to conform to the geometry of the clipped native valve.” Limitation not disclosed in provisional application.
In regards to claim 25, applicant recites: “an occluder that can be disposed between the native leaflets when the leaflets are engaged by the clip, the occluder configured to selectively permit blood to flow in a first direction between the native leaflets and the occluder and to inhibit blood from flowing in a second, opposite direction between the native leaflets and the occluder.” Limitation not disclosed in provisional application.
Therefore, claims 1-13, 15-16, 18, 20-23, 25 and 27 have been afford a priority date of 07/01/2021.
Claim Objections
Claims 1 and 15 are objected to because of the following informalities: Both claims cited should start with “An”. Appropriate correction is required.
Claims 3 is objected to because of the following informalities: “the biasing element elastically deformable from the intermediate configuration toward a second, opposite element configuration in response to blood flow in the second direction as the occluder assumes the open configuration”, Examiner cannot determine configuration for the “second, opposite element”. Appropriate correction is required.
Claims 9 objected to because of the following informalities: “10. The apparatus of claim 1, further comprising the clip.” Each claim is to consist of only one sentence, for further guidance regarding claim construction please refer to MPEP § 608.01(m). Examiner recommends removing the extra sentence included in claim 9. At the moment claim 10 is canceled. Appropriate correction is required.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Appropriate correction is required. Examiner recommends rewriting to meet length and narrative form requirements and removing legal phraseology from the current abstract.
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) 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spence et al. WO 2019157331 A1, herein referred to as Spence.
Regarding claim 15, Spence discloses an apparatus (Figs 14c, 22l; also disclosed as 22a-l) comprising: an occluder (Fig 14c, 120) configured to be disposable between a first native leaflet and a second native leaflet of a native heart valve (Fig 5c; [0148]]), in a flow control portion of the native valve formed between the native leaflets([0023]), a commissure of the native leaflets (Fig 5c), and a clip (Fig 14c, 50a and 50b) securing the margins of the native leaflets together (Fig 12b), the occluder configured to selectively permit blood to flow in a first direction between the native leaflets (Fig 12b; [0023]) and the occluder and to inhibit blood from flowing in a second ([0143]), opposite direction between the native leaflets and the occlude ([0143]); and a support frame (Fig 15A-D, 30i) coupled to the occluder and coupleable to the clip to secure the support frame and the occluder in the native valve with the occluder disposed in the flow control portion of the native valve (Fig 15a-d), the support frame configured to be adjustable to conform to the geometry of the clipped native valve ([0124]).
Regarding claim 16, Spence discloses wherein the support frame includes an occluder arm coupleable (Fig 5c, 38- Fig 5d) to the clip at a first end thereof (Fig 5c-d), the occluder coupled to the occluder arm for movement along the occluder arm toward and away from the first end of the occluder arm (Holding arm holding the occlude would allow some movement in relation to blood flow).
Claim(s) 18, 20-23, 25 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence in view of Franklin et al. WO 2019199421 A1, herein referred to as Franklin.
Regarding claim 18, Spence discloses the invention substantially as claimed and as discussed above with respect to claim 15, but does not disclose wherein the support frame includes an occluder arm coupled to the occluder, and an occluder arm pivot coupleable to the clip and coupled to the occluder arm, the occluder arm pivot being pivotably adjustable relative to the clip to dispose the occluder at a variable angular orientation relative to the clip.
But Franklin teaches wherein the support frame includes an occluder (Fig 5a, 132) arm coupled to the occluder (Fig 5a, 132), and an occluder arm (Fig 2, 134b) pivot coupleable to the clip (102) and coupled to the occluder arm (Fig 5a), the occluder arm pivot being pivotably adjustable relative to the clip to dispose the occluder at a variable angular orientation relative to the clip ([0146]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Spence/Cao to incorporate wherein the support frame includes an occluder arm coupled to the occluder, and an occluder arm pivot coupleable to the clip and coupled to the occluder arm, the occluder arm pivot being pivotably adjustable relative to the clip to dispose the occluder at a variable angular orientation relative to the clip, as taught and suggested by Franklin in order to prevent regurgitation (Franklin [0092]).
Regarding claim 20, Spence/Franklin discloses the invention substantially as claimed and as discussed above with respect to claim 18, and additionally teaches wherein the flow control portion is a first flow control portion (Spence Fig 5c, center valve depicted), the commissure is a first commissure commissure (Spence Fig 5c, one can be considered first, the occluder is a first occlude (Spence 12A, two element 120 present, one may consider first), and the occluder arm is a first occluder arm (Spence Fig 2, 134b shows a plurality one can be considered the first), the native heart valve having a second flow control portion (The other half of the annulus) formed between the native leaflets, the clip, and a second commissure of the native leaflets Spence Fig 5c; Second half of the annulus),
further comprising: a second occluder arm coupled to the occluder arm pivot (Franklin Fig 2, 134b shows a plurality one can be considered the second), and a second occluder coupled to the second occlude arm (Fig 2, 134b shows a plurality one can be considered the second) and configured to be disposable in the second flow control portion (Spence Fig c) and to selectively permit blood to flow in the first direction through the second flow control portion between the native leaflets (Spence Fig 12b; [0023])) and the second occluder and to inhibit blood from flowing in the second direction through the second flow control portion between the native leaflets and the second occlude (Spence [0143]), the occluder arm pivot being further adjustable relative to the clip to dispose the second occluder at a variable angular orientation relative to the clip (Franklin [0146]), the first and second occluder coupled to the first and second occluder arm, respectively, for movement along the first and second occluder arm, respectively, toward and away from the occluder arm pivot (Franklin [0146]).
Regarding claim 21, Spence/Franklin discloses the invention substantially as claimed and as discussed above with respect to claim 18, and additionally teaches wherein the occluder arm pivot is pivotably adjustable relative to the clip to tilt the occluder laterally relative to a vertical axis of the clip (Franklin [0146]).
Regarding claim 22, Spence/Franklin discloses the invention substantially as claimed and as discussed above with respect to claim 18, and additionally teaches wherein the occluder arm pivot is pivotably adjustable relative to the clip to tilt the occluder longitudinally relative to a vertical axis of the clip, to dispose the occluder higher or lower relative to the clip (Franklin [0146]; Fig 2 and 5a).
Regarding claim 23, discloses the invention substantially as claimed and as discussed above with respect to claim 18, and additionally teaches wherein the support frame is coupleable to the clip for selective axial positioning relative to the clip to set a height of the support frame relative to the clip, and thereby the height of the occluder in the flow control portion (Franklin Fig 2and 5a; [0146]).
Regarding claim 25, Spence/Franklin discloses the invention substantially as claimed and as discussed above with respect to claim 18, and additionally teaches a clip (Spence Fig 14c, 50a and 50b) for a leaflet clipping procedure on a native heart valve having native leaflets (intended use), comprising:
a body portion (Franklin Fig 7, 118); a first paddle (Franklin Fig 7, 142) configured to engage a first native leaflet between the paddle and the body portion (Franklin Fig 7);
a second paddle (Franklin 142 is mirrored on the other side) configured to engage a first second native leaflet between the paddle and the body portion (Franklin Fig 12);
and one or more elements coupled to the body portion and configured to be engaged by-a selective occlusion device an occluder (Spence Fig 14c, 120) that can be disposed between the native leaflets when the leaflets are engaged by the clip (intended use), the occluder configured to selectively permit blood to flow in a first direction between the native leaflets and the occluder (Spence Fig 12b; [0023])and to inhibit blood from flowing in a second, opposite direction between the native leaflets and the occlude (Spence [0143]).
Regarding claim 27, Spence/Franklin discloses the invention substantially as claimed and as discussed above with respect to claim 25, and additionally teaches a system (Spence Figs 14c, 22l; also disclosed as 22a-l) including the clip of claim 25 and the occluder coupled to the clip via the one or more elements, and wherein the one or more elements include one or more of a channel, a groove, a loop, a circle, and a surface configured to be engaged by the occlude (Fig 15A-D, 30i; 30 forms a groove).
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.
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.
Claim(s) 1-6, 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence in view of Cao et al. US 20180185154 A1, herein referred to as Cao.
Regarding claim 1, Spence discloses an apparatus (Figs 14c, 22l; also disclosed as 22a-l) comprising: an occluder (Fig 14c, 120) configured to be disposable between a first native leaflet (Fig 5c, 16a) and a second native leaflet (Fig 5c, 16b) of a native heart valve (Fig 5c), in a flow control portion of the native valve formed between the native leaflets (Fig 5c; [0148]]), a commissure (Fig 12B, 16c; [0129]) of the native leaflets, and a clip (Fig 14c, 50a and 50b) securing the margins of the native leaflets together (Fig 12b), the occluder configured to selectively permit blood to flow in a first direction between the native leaflets ([0023]) and the occluder and to inhibit blood from flowing in a second ([0143]), opposite direction between the native leaflets and the occluder, the occluder formed at least in part from a first flexible membrane (Fig , 44) having a first free margin (44a above the horizontal bar 32 in figure 18A) and a second flexible membrane having a second free margin (44a below the horizontal bar 32 in figure 18A), the flexible membranes movable in response to the flow of blood adjacent thereto ([0174-0175]); Teaches movable in conjunction with leaflets, leaflets function in response to flow),
at least one of the first flexible membrane movable away from the first native leaflet (Fully capable) and the second flexible membrane movable away from the second native leaflet (Fully capable), to a closed configuration ([0021]; teaches closed condition) of the occluder in which the first free margin and the second free margin are adjacent (Fig 18A), in response to blood flow in the first direction,
at least one of the first flexible membrane and the second flexible membrane movable toward the first native leaflet and the second native leaflet, respectively (Fig 18b; [0159]), and the first flexible membrane and the second flexible membrane coaptable with the first native leaflet and the second native leaflet, respectively, in an open configuration ([0021]; Fig 18b) in which the first free margin and the second free margin are fully spaced apart, in response to blood flow in the second direction, and
the first flexible membrane (Fig 13c, 120; [0137]; teaches a flexible membrane to cover these elements) and the second flexible (120; two separate membranes shown in Fig 14c) membrane disposable in an intermediate configuration ([0125]; teaches slightly open position in reference to flexible membranes) in which the first free margin and the second free margin are partially spaced, less than in the open configuration ([0125]);
a support frame (Fig 15A-D, 30i) coupled to the occluder and coupleable to the clip to secure the support frame (Fig 14cm couple by 54) and the occluder in the native valve with the occluder disposed in the flow control portion of the native valve (Fig 16d); and a membrane spacing element (frame member 32 with support member 38), the membrane spacing element configured to permit the flexible membranes to move from the intermediate configuration to the closed configuration in response to blood flow in the first direction and to move from the intermediate configuration to the open configuration in response to blood flow in the second direction ([0124-0125]).
But does not disclose explicitly disclose a membrane spacing element configured to dispose the flexible membranes in the intermediate configuration in response to a substantial absence of blood flow between the native leaflets.
But Cao teaches a membrane spacing element (Fig 3, 60,68) configured to dispose the flexible membranes in the intermediate configuration in response to a substantial absence of blood flow between the native leaflets ([0055] Cao teaches resilient material; as recited Cao would return to intermediate configuration in response to absence of blood flow).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Spence to incorporate wherein a membrane spacing element configured to dispose the flexible membranes in the intermediate configuration in response to a substantial absence of blood flow between the native leaflets, as taught and suggested by Cao in order enable compression of the clip (Cao [0055])
Regarding claim 2, Spence/Cao discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the membrane spacing element is disposed between the first flexible membrane and the second flexible membrane (Spence 14c), and is configured to urge the first free margin and the second free margin away from each other towards the intermediate configuration (Cao [0055]); Cao’s memory material would urge the free margins away from each other).
Regarding claim 3, Spence/Cao discloses the invention substantially as claimed and as discussed above with respect to claim 2, and additionally teaches an elastically-deformable biasing element (Cao 60, 68) coupled to at least a portion of both the first and the second flexible membranes, the biasing element assuming a predetermined, intermediate element configuration during the substantial absence of blood flow between the native leaflets thereby disposing the flexible membranes in the intermediate configuration (Cao [0055]), the biasing element elastically deformable from the intermediate element configuration toward a first element configuration in response to blood flow in the first direction as the occluder assumes the closed configuration (Cao [0085]), the biasing element elastically deformable from the intermediate configuration toward a second opposite element configuration in response to blood flow in the second direction as the occluder assumes the open configuration (Cao [0085]).
Regarding claim 4, Spence/Cao discloses the invention substantially as claimed and as discussed above with respect to claim 2, and additionally teaches the membrane spacing element includes a first rib stiffener (Spence Fig 7a, 38) formed on the first flexible membrane and a second rib stiffener portion formed on the second flexible membrane (Spence Fig 7a, 38 mirrored but not numbered on the other side).
Regarding claim 5, Spence/Cao discloses the invention substantially as claimed and as discussed above with respect to claim 2, and additionally teaches wherein the flexible membranes are formed of polymer material (Cao [0055]), and the rib stiffeners are integrally formed therewith (Spence Fig 7a).
Regarding claim 6, Spence/Cao discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the native valve is an atrioventricular valve (Spence [0010]) having an annulus disposed between an atrium of the heart above the annulus (Spence [0015]) and a ventricle of the heart below the annulus (Spence Fig 5a), the frame has a first portion (Spence Fig 12b, 54 portion closest to element 32a) couplable to the clip proximate to a first end of the occluder (Spence Fig 12b) and second portion (Spence Fig 12b, 54 portion closet to 50), spaced from the first portion, proximate to a second end of the occlude (Spence Fig 12b).
But does not explicitly disclose further comprising a ventricular connector coupled to the second portion of the frame, the ventricular connector including a tissue anchor configured to penetratingly engage with tissue of the ventricle, the occluder being securable in operative position in the native valve, and resistant to displacement from the operative position by the flow of blood in the first direction and the second direction between the atrium and the ventricle, by engagement of the frame with the clip and with the ventricular connector.
However, in another embodiment Cao teaches further comprising a ventricular connector coupled (Cao Fig 6, 80) to the second portion of the frame (Cao Fig 6), the ventricular connector including a tissue anchor configured to penetratingly (Fig 10a-b, 354); [0082] engage with tissue of the ventricle (Cao Fig 6), the occluder being securable in operative position in the native valve (Cao [0082]), and resistant to displacement from the operative position by the flow of blood in the first direction and the second direction between the atrium and the ventricle, by engagement of the frame with the clip and with the ventricular connector (Cao [0082]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Spence/Cao to incorporate further comprising a ventricular connector coupled to the second portion of the frame, the ventricular connector including a tissue anchor configured to penetratingly engage with tissue of the ventricle, the occluder being securable in operative position in the native valve, and resistant to displacement from the operative position by the flow of blood in the first direction and the second direction between the atrium and the ventricle, by engagement of the frame with the clip and with the ventricular connector, as taught and suggested by Cao in order to allow strong engagement in a heart (Cao [0082]).
Regarding claim 9, Spence/Cao discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches further comprising the clip, wherein the occluder is a first occluder (Spence 12A, two element 120 present, one may consider first), the flow control portion is a first flow control portion (Spence Fig 5c, center valve depicted), and the commissure is a first commissure (Spence Fig 5c, one can be considered first), and further comprising a second occluder (Spence 12A, two element 120 present, the other may be considered the second occluder) configured to be disposable between the first native leaflet and the second native leaflet (Spence Fig 5c), in a second flow control portion of the native valve formed between the native leaflets (Spence Fig 5c, second half of the annulus), a second commissure of the native leaflets, and the clip (Spence Fig 5c; Second half of the annulus).
Regarding claim 12, Spence/Cao discloses the invention substantially as claimed and as discussed above with respect to claim 6, and additionally teaches wherein the tissue anchor is one of a barb (Cao Fig 10a, 354), helically wound wire (Cao [0091]), clip, and multi-pronged anchor (Cao Fig 10a, plurality 354 makeup anchor 342).
Claim(s) 7- 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence in view of Cao, and further in view of Franklin.
Regarding claim 7, Spence/Cao discloses the invention substantially as claimed and as discussed above with respect to claim 6, and additionally teaches wherein the apparatus, when disposed in the native valve with the first portion of the frame coupled to the clip and with the ventricular connector coupled to ventricular tissue of the heart by the tissue anchor (Cao Fig 6, Fig 10a-b)
But does not explicitly disclose an occluder pivoting axis defined between a location at which the clip is engaged with native leaflets and a location at which the tissue anchor is engaged with the ventricular tissue, the apparatus configured so that the occluder can pivot about the occluder pivot axis, the occluder configured such that when in the open configuration in the heart, the occluder has a center of pressure formed by higher pressure blood on the ventricle side of the occluder and lower pressure blood on an atrial side of the occluder, the center of pressure being positioned above the occluder pivot axis
But Franklin teaches an occluder (Fig 5A, 132) pivoting axis (Annotated Fig 3 below) defined between a location at which the clip (Fig 9, 102) is engaged with native leaflets ([0008]) and a location at which the tissue anchor is engaged with the ventricular tissue (Fig 6, 134; [0146]), the apparatus configured so that the occluder can pivot about the occluder pivot axis ([0146] Inflation causes occluders to pivot with flow of blood), the occluder configured such that when in the open configuration ([0083]; Fig 5 open position) in the heart (Fig 17), the occluder has a center of pressure formed by higher pressure blood on the ventricle side of the occluder and lower pressure blood on an atrial side of the occluder, the center of pressure being positioned above the occluder pivot axis ([0126] Capable of being place lower in the annulus, thus moving the center of pressure to the ventricular side).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Spence/Cao to incorporate wherein an occluder pivoting axis defined between a location at which the clip is engaged with native leaflets and a location at which the tissue anchor is engaged with the ventricular tissue, the apparatus configured so that the occluder can pivot about the occluder pivot axis, the occluder configured such that when in the open configuration in the heart, the occluder has a center of pressure formed by higher pressure blood on the ventricle side of the occluder and lower pressure blood on an atrial side of the occluder, the center of pressure being positioned above the occluder pivot axis, as taught and suggested by Franklin in order to prevent regurgitation (Franklin [0092]).
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Regarding claim 8, Spence/Cao/Franklin discloses the invention substantially as claimed and as discussed above with respect to claim 7, and additionally teaches wherein the apparatus has an occluder pivoting axis defined between a point on the first portion of the frame configured to engage the clip and the tissue anchor (Franklin Annotated Fig 3), the apparatus configured so that the occluder can pivot about the occluder pivot axis (Franklin [0146]), the tissue anchor being disposed below at least a portion of the lower edge of at least one of the first free margin and the second free margin (Franklin annotated Fig 3 above; Cao Fig 10; Tissue anchor of Cao would be disposed below in this combination as the inflatable occluders of Franklin are to be position above the leaflets and/or directly between the leaflets).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence in view of Cao, and further in view of Geist et al. US 20140222136 A1, herein referred to as Geist.
Regarding claim 13, Spence/Cao discloses the invention substantially as claimed and as discussed above with respect to claim 6, and additionally teaches wherein the tissue anchor includes a flexible tether (Cao Fig 10a, 412) coupled to the support frame and having a tissue penetrating barb element at a distal end therefore (Cao Fig 10a),
But does not explicitly disclose wherein the tissue anchor configured to be engaged with a papillary muscle of the ventricle.
But Geist teaches wherein the tissue anchor (4006) configured to be engaged with a papillary muscle of the ventricle ([0122] and [0218]; Fig 84, 22).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Spence/Cao to incorporate disclose wherein the tissue anchor configured to be engaged with a papillary muscle of the ventricle, as taught and suggested by Geist in order to avoid entanglement with adjacent anatomy (Geist [0218]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799