DETAILED ACTION
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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “plurality of stitches” of claim 5, the “third cover piece” of claim 8, the “first paddle frame” and “second paddle frame” and “first sleeve” and “second sleeve” of claim 9, the “indicator” of claim 13 must be shown or the features canceled from the claims. No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "12510" and "12670" and “12756” have all been used to designate “cutout portions”. 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification fails to disclose the “third cover piece” or “portion”, as the first and second pieces are disclosed, of claim 8 and the “first paddle frame” and “second paddle frame” of claim 9.
Claim Objections
Claims 18-19 are objected to because of the following informalities: claims 18-19 state “wherein second cover portion” rather than “wherein the second cover portion”. Appropriate correction is required.
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)(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.
(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.
Claims 1-4, 6-12, 14-18, and 21-23 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Metchik et al. (US 2019/0069991 A1), “Metchik”.
Regarding claim 1, Metchik teaches
An implantable device comprising: an anchor portion configured to attach to one or more leaflets of a native heart valve (Fig. 8B, prosthetic spacer device 200 comprises spacer member 202 and engages with valve leaflets [0085]),
the anchor portion comprising one or more anchors (Fig. 8B, anchors 204),
wherein each anchor has a paddle frame (Fig. 6, anchor extension members 212);
one or more sleeves attached to the paddle frame (Fig. 12A, portions of cover 250 disposed above anchors 204);
and a cover for covering at least a portion of the paddle frame (Fig. 12A, portions of cover 250 disposed over anchors 204 and extension members 212 [0088]),
wherein the cover is attached to the one or more sleeves (Fig. 12A, cover 250 encompasses prosthetic spacer device 200 and its parts).
Regarding claim 2, Metchik teaches
wherein the one or more sleeves are lubricious to facilitate movement of the implantable device through native structures of a patient’s heart (Fig. 12A, cover 250 is comprised of various materials suitable for cardiac delivery [0088] (i.e., smooth and biocompatible)).
Regarding claim 3, Metchik teaches
wherein the one or more sleeves have a lower coefficient of friction than the paddle frame (Fig. 12A, anchor extension members 112 comprise a nitinol wire [0065] whereas cover 250 may comprise UHMWPE [0088]). Examiner notes that the coefficient of friction of nitinol has been found to be 0.6 under dry friction (https://www.sciencedirect.com/science/article/pii/S1003632611614817) whereas the coefficient of friction of UHMWPE has been found to be 0.09 to 0.10 (https://www.sciencedirect.com/science/article/pii/S0921509399000404).
Regarding claim 4, Metchik teaches
wherein the paddle frame (Fig. 6, anchor extension members 212) has an inner frame portion (Fig. 6, clasps 206) and an outer frame portion (Fig. 6, anchor extension member 212 and first and second portions 220, 222 along with joint portion 218),
and wherein first and second sleeves of the one or more sleeves are attached to the inner frame portion (Fig. 12A, portions of cover 250 envelope clasps 206) and
third and fourth sleeves of the one or more sleeves are attached to the outer frame portion (Fig. 12A, portions of cover 250 envelope anchors 204).
Regarding claim 6, Metchik teaches
wherein the one or more sleeves are made of a material that promotes tissue ingrowth (Fig. 12A, cover 250 comprises any of ePTFE, PET, or UHMWPE [0088]).
Regarding claim 7, Metchik teaches
further comprising a coaptation element (Fig. 6, spacer member 202), and wherein each of the one or more anchors (Fig. 6, anchors 204) includes an inner paddle (Fig. 6, first portion 220), an outer paddle (Fig. 6, second portion 222), and a clasp (Fig. 6, clasps 206).
Regarding claim 8, Metchik teaches
wherein the cover (Fig. 12A, cover 250) comprises a first cover piece for covering at least a portion of the paddle frame (Fig. 8B, portion of cover 250 surrounding anchor extension members 212),
a second cover piece for covering at least a portion of the inner paddle (Fig. 8B, portion of cover 250 surrounding first portion 220),
and a third cover piece for covering at least a portion of the coaptation element and the clasp (Fig. 8B, portion of cover 250 surrounding spacer member 202 and clasps 206).
Regarding claim 9, Metchik teaches
wherein: the anchor portion (Fig. 6, anchors 204) includes a first paddle frame (Fig. 6, first and second portions 220, 222),
a second paddle frame (Fig. 6, anchor extension members 212), and
a connector (Fig. 6, first end portions 214);
the one or more sleeves comprise a first sleeve and a second sleeve (Figs. 8B, 12A, portions of cover 250);
the first sleeve is disposed over at least a portion of the first paddle frame and at least a portion of the connector (Fig. 12A, portion of cover 250 surrounding first and second portions 220, 222 and connected to first end portions 214); and
the second sleeve is disposed over at least a portion of the second paddle frame (Fig. 12A, cover 250 surrounds anchor extension members 212).
Regarding claim 10, Metchik teaches
An implantable device comprising: a coaptation portion (Fig. 6, prosthetic spacer device 200) having a coaptation element (Fig. 6, spacer member 202);
an anchor portion configured to attach to one or more leaflets of a native heart valve (Fig. 8B, prosthetic spacer device 200 comprises anchor 204 and engages with valve leaflets [0085]),
the anchor portion comprising a first anchor (Fig. 6, left anchor 204) and a second anchor (Fig. 6, right anchor 204),
wherein each of the first anchor and the second has a paddle frame (Fig. 6, anchors 204 comprise first and second portions 220, 222 and anchor extension members 212 which form a frame),
an inner paddle (Fig. 7, first portion 220),
an outer paddle (Fig. 7, second portion 222),
and a clasp (Fig. 6, clasps 206);
a cover assembly (Fig. 8B, cover 250) that includes: a first cover for covering at least a portion of the paddle frame of both of the first anchor and the second anchor (Fig. 12A, portions of cover 250 surrounding both left and right anchors 204);
a pair of second covers (Fig. 12A, portions of cover 250 surrounding interior of anchors 204),
wherein one second cover covers at least a portion of the inner paddle of the first anchor (Fig. 12A, portion of cover 250 surrounding first portion 220 (i.e., interior of paddle 204) on left anchor 204) and
the other second cover covers at least a portion of the inner paddle of the second anchor (Fig. 12A, portion of cover 250 surrounding first portion 220 (i.e., interior of paddle 204) on right anchor 204); and
a third cover for covering at least a portion of the coaptation element (Fig. 12A, portions of cover 250 surround spacer member 202), at least a portion of the clasp of the first anchor, and at least a portion of the clasp of the second anchor (Fig. 12A, portions of cover 250 surround clasps 206).
Regarding claim 11, Metchik teaches
wherein each second cover of the pair of second covers comprises a first portion disposed on the inner paddle proximate the coaptation element (Fig. 12A, uppermost portion of cover 250 surrounding the first portion 220 (i.e., interior of paddle 204)) and
a second portion that extends from the first portion and is disposed on a portion of the inner paddle that is furthest from the coaptation element (Fig. 12A, lowermost portion of cover 250 surrounding the first portion 220 (i.e., interior of paddle 204)).
Regarding claim 12, Metchik teaches
wherein each second cover of the pair of second covers (Fig. 12A, portions of cover 250 surrounding interior of anchors 204) comprises cutout portions that assist in wrapping the second covers around the corresponding inner paddle (Fig. 8B, cover 250 comprises openings 252 [0161]).
Regarding claim 14, Metchik teaches
wherein the third cover (Fig. 8B, portion of cover 250 surrounding spacer member 202) comprises a middle portion attached to a component at a proximal end of the implantable device (Fig. 8B, region of cover 250 surrounding spacer member 202 nearest proximal collar 210),
first and second coaptation portions that extend from the middle portion and cover at least a portion of the coaptation element (Fig. 8B, portions (left and right sides) of cover 250 surrounding spacer member 202 distal to region of cover 250 surrounding spacer member 202 nearest proximal collar 210),
a first end portion that extends from the first coaptation portion and covers at least a portion of the clasp of the first anchor (Fig. 8B, portion (left side) of cover 250 surrounding spacer member 202 nearest distal collar 208), and
a second end portion that extends from a second coaptation portion and covers at least a portion of the clasp of the second anchor (Fig. 8B, portion (right side) of cover 250 surrounding spacer member 202 nearest distal collar 208).
Regarding claim 15, Metchik teaches
further comprising one or more sleeves attached to the paddle frame of each of the first anchor and the second anchor (Fig. 12A, cover 250 surrounds anchors 204 entirely).
Regarding claim 16, Metchik teaches
An implantable device comprising: an anchor portion configured to attach to one or more leaflets of a native heart valve (Fig. 8B, prosthetic spacer device 200 comprises anchor 204 and engages with valve leaflets [0085]);
a first cover portion attached to the anchor portion (Fig. 12A, portions of cover 250 surrounding clasps 206 with barbs);
a second cover portion attached to the anchor portion (Fig. 12A, portions of cover 250 surrounding anchors 204); and
wherein the second cover portion has a lower coefficient of friction than the first cover portion (Fig. 12A, portions of cover 250 surrounding anchors 204 which do not comprise barbs (i.e., lower coefficient of friction)).
Regarding claim 17, Metchik teaches
wherein the second cover portion covers an edge of the anchor portion (Fig. 8B, portions of cover 250 surround sides (i.e., edges) of anchors 204).
Regarding claim 18, Metchik teaches
wherein second cover portion comprises a hydrophilic material (Fig. 8B, cover 250 may comprise various non-woven fabrics such as gauze [0088]).
Regarding claim 21, Metchik teaches
wherein the anchor portion comprises a plurality of paddles (Fig. 6, spacer member 202 comprises two anchors 204) and
the first cover portion and the second cover portion are attached to the plurality of paddles (Fig. 8B, portions of cover 250 surrounding both left and right paddles 204).
Regarding claim 22, Metchik teaches
wherein the second cover portion covers an edge of each of the plurality of paddles (Fig. 8B, portions of cover 250 surrounding paddles 204 and surrounding anchor extension members 212).
Regarding claim 23, Metchik teaches
wherein the second cover portion comprises a knitted material and wales of the knitted material are oriented longitudinally (Fig. 8B, cover 250 comprises low-density knitted polyester fabric having 60-120 courses per inch and 20-60 wales per inch [0088]).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Metchik et al. (US 2019/0069991 A1), “Metchik” in view of McCann et al. (US 2020/0237512 A1), “McCann”.
Regarding claim 5, Metchik teaches the cover (Fig. 12A, cover 250) and sleeves (Fig. 12A, portions of cover 250 disposed above anchors 204 and other regions) but fails to teach they are attached by a plurality of stitches.
McCann teaches a valve repair device comprising covers attached by a plurality of stitches (Fig. 197, cover 543A is attached by stitches 545A [0489]). McCann discloses that the cover is held in place by the stitches [0489]. 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 cover and sleeves taught by Metchik with the stitches taught by McCann in order to ensure there is no extraneous movement of the cover and sleeves on the implant that could cause damage to it.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Metchik et al. (US 2019/0069991 A1), “Metchik” in view of Goldfarb et al. (US 2007/0197858 A1), “Goldfarb”.
Regarding claim 13, Metchik teaches each second cover of the pair of second covers (Fig. 12A, portions of cover 250 surrounding interior of anchors 204) but fails to teach a window that allows an indicator of the implantable device to be visible to a user during implantation of the implantable device.
Goldfarb teaches a fixation device comprising a window (Fig. 31A, angle Ɵ is visible or invisible depending upon positioning of flap 240 [0121]) that allows an indicator of the implantable device to be visible to a user during implantation of the implantable device (Figs. 31A-B, ultrasound receiving indicator (i.e., flap 240) resonates or vibrates at a particular ultrasonic frequency that is used for visualization on an ECG to indicate whether or not the tissue is sufficiently grasped [0116, 0121]). Goldfarb discloses that the visualization techniques utilizing ECG allows the practitioner to actively evaluate the grasp of the device on the tissue in real time [0116]. 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 second cover taught by Metchik with the indicator taught by Goldfarb in order to allow for real time adjustments of the implant to ensure a secure delivery.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Metchik et al. (US 2019/0069991 A1), “Metchik” in view of Roth (US 2020/0254140 A1), “Roth”.
Regarding claim 19, Metchik teaches a second cover portion (Fig. 12A, portions of cover 250 surrounding interior of anchors 204) but fails to teach a coating of a friction-reducing material.
Roth teaches a medical device comprising a coating of a friction-reducing material (polymers can be coated on the medical device to reduce friction [0025]). Roth discloses that the coating on the device may improve strength, durability, and biocompatibility of the implant [0025]. 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 second cover portion taught by Metchik with the coating taught by Roth in order to increase the strength and biocompatibility of the device.
Regarding claim 20, Metchik fails to teach the limitations of claim 20. Roth teaches a medical device wherein the coating is a temporary coating (polymer coating used to reduce friction can be biodegradable or absorbed into the body (i.e., dissolves after a period of time) [0025]). Roth discloses that the coating on the device may improve strength, durability, and biocompatibility of the implant [0025]. 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 second cover portion taught by Metchik with the coating taught by Roth in order to increase the strength and biocompatibility of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2019/0321166 A1, US 2019/0053803 A1, US 2019/0000613 A1, and US 2016/0331523 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.G.R./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799