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 .
Claim Status
Applicant’s Remarks and Amendments filed 21 May 2026 have been entered. Claims 5 and 15 are cancelled. Claims 1-4, 6-14, and 16-23 are pending.
Response to Arguments
Applicant’s arguments, see pg. 8 of remarks, filed 21 May 2026, with respect to the drawings have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see pg. 9 of remarks, filed 21 May 2026, with respect to claim 13 have been fully considered and are persuasive. The 112(b) rejection of claim 13 has been withdrawn.
Applicant’s arguments, see pg. 10 of remarks, filed 21 May 2026, with respect to the specification have been fully considered and are persuasive. The objection to the specification has been withdrawn.
Applicant's arguments filed 21 May 2026 regarding the 102 and 103 rejections of the claims have been fully considered but they are not persuasive. Regarding Applicant’s argument that the amended claims 1 and 10 “recite features that are not disclosed or suggested by the combined teachings of the applied references” (pg. 10 of remarks), Examiner respectfully disagrees. The amended claim language regarding a sleeve, under current broadest reasonable interpretation of the claims, is taught by the cover of Metchik. Further, it is unclear whether Applicant’s “sleeve” is a portion/part of the cover of the device, or a separate covering entirely that is positioned beneath the cover, or in some other way. The current specification and drawings offer no further clarification for the Examiner. Metchik’s cover comprises portions which individually cover the left and right anchors. These covered portions would form a sleeve of sorts that fits to the shape of the anchor, i.e., a tube, and comprise an open portion within for the anchor itself. Therefore the rejection is maintained.
Claim Objections
Claim 11 is objected to because of the following informalities: lines 3-4 state “...proximate the coaptation element and and is disposed on a portion…”. 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.
Claims 1-4 and 6-9 are 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 1 recites the limitation "the paddle frame" in claim 1. There is insufficient antecedent basis for this limitation in the claim. Claims 2-4 and 6-9 are rejected by dependency.
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 (Fig. 8B, prosthetic spacer device 200 comprising spacer member 202, anchors 204, clasps 206, and collars 208, 210 [0082]) comprising a first paddle frame (Fig. 7, left anchor 204 and clasp 206) and a second paddle frame (Fig. 7, right anchor 204 and clasp 206);
a first sleeve comprising a tube having a first end, a second end, and a lumen extending therebetween (Fig. 8B, portion of cover 250 enclosing left anchor 204 which comprises a lower and upper end and an opening within to house the anchor 204);
wherein the first sleeve is disposed over the first paddle frame to attach the first sleeve to the first paddle frame (Fig. 8B, portion of cover 250 encircles left anchor 204);
a second sleeve comprising a tube having a first end, a second end, and a lumen extending therebetween (Fig. 8B, portion of cover 250 enclosing right anchor 204 which comprises a lower and upper end and an opening within to house the anchor 204);
wherein the second sleeve disposed over the second paddle frame to attach the second sleeve to the second paddle frame (Fig. 8B, portion of cover 250 encircles right anchor 204); and
a cover for covering at least a portion of the paddle frame (Fig. 8B, cover 250 covers anchors 204 and spacer member 202),
wherein the cover is attached to the first sleeve and the second sleeve (Fig. 12A, regions of cover 250 enclosing spacer member 202 further attach to regions of cover 250 enclosing anchors 204).
Regarding claim 2, Metchik teaches
wherein the first sleeve and the second sleeve 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 first sleeve and the second sleeve 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 the first and second 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 anchor portion (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) covers at least a portion of the paddle frame (Fig. 8B, portion of cover 250 surrounding anchor extension members 212),
covers at least a portion of the inner paddle (Fig. 8B, portion of cover 250 surrounding first portion 220), and
covers 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 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).
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 has a first paddle frame (Fig. 6, left anchor 204 comprises first and second portions 220, 222 and anchor extension members 212 which form a frame), a first inner paddle (Fig. 7, left first portion 220), a second inner paddle (Fig. 7, left second portion 222), and a first clasp (Fig. 6, left clasp 206) and
the second anchor has a second paddle frame (Fig. 6, right anchor 204 comprises first and second portions 220, 222 and anchor extension members 212 which form a frame), a second inner paddle (Fig. 7, right first portion 220), a second outer paddle (Fig. 7, right second portion 222), and a second clasp (Fig. 6, right clasp 206);
a first sleeve that is a cylindrical tube having a first end, a second end and a lumen extending therebetween (Fig. 8B, portion of cover 250 enclosing left anchor 204 which comprises a lower and upper end and an opening within to house the anchor 204);
wherein the first sleeve is disposed over the first paddle frame (Fig. 8B, portion of cover 250 encircles left anchor 204);
a second sleeve that is a cylindrical tube having a first end, a second end and a lumen extending therebetween (Fig. 8B, portion of cover 250 enclosing right anchor 204 which comprises a lower and upper end and an opening within to house the anchor 204);
wherein the second sleeve is disposed over the second paddle frame (Fig. 8B, portion of cover 250 encircles right anchor 204);
a cover assembly (Fig. 8B, cover 250) that:
covers at least a portion of the first inner paddle (Fig. 12A, portion of cover 250 surrounding first portion 220 (i.e., interior of paddle 204) on left anchor 204) and
covers at least a portion of the second inner paddle (Fig. 12A, portion of cover 250 surrounding first portion 220 (i.e., interior of paddle 204) on right anchor 204)
covers at least a portion of the coaptation element (Fig. 12A, portions of cover 250 surround spacer member 202), covers at least a portion of the first clasp, and covers at least a portion of the second clasp (Fig. 12A, portions of cover 250 surround clasps 206).
Regarding claim 11, Metchik teaches
wherein the cover assembly is disposed on the first inner paddle and the second 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
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 the cover assembly (Fig. 12A, portions of cover 250 surrounding interior of anchors 204) comprises cutout portions that assist in wrapping the cover assembly around the first inner paddle and the second inner paddle (Fig. 8B, cover 250 comprises openings 252 [0161]).
Regarding claim 14, Metchik teaches
wherein the cover assembly (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 16, Metchik teaches
An implantable device comprising: an anchor portion having barbs configured to attach to one or more leaflets of a native heart valve (Fig. 8B, prosthetic spacer device 200 comprising spacer member 202, anchors 204, clasps 206 comprising barbs 236 [0150], and collars 208, 210 [0082]);
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 the 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 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 the cover assembly (Fig. 12A, portions of cover 250 surrounding interior of anchors 204) but fails to teach a window.
Goldfarb teaches a fixation device comprising a window (Fig. 31A, angle Ɵ is visible or invisible depending upon positioning of flap 240 [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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA G. B. RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 9:00AM-6:00PM CST.
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/G.G.R./ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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