DETAILED ACTION
The following is a non-final office action is response to communications received on 05/01/2024. Claims 1-20 are currently pending and addressed below.
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 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 13 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 13 recites the limitation "the anchors" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 8-12, 14-16 & 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ma et al. (WO 2015/057407).
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Regarding Claim 8, Ma teaches a heart valve prosthesis (20a) comprising:
a self-expanding frame (page 8: lines 11-15) adapted to radially collapse for advancement through a patient’s vasculature and radially expand for deployment within a native heart valve annulus of the patient;
a first anchoring feature (22a) extending from a proximal end portion of the frame, the first anchoring feature extending radially outwardly and then curving upwardly upon deployment of the frame (Fig 16), the first anchoring feature being sized for placement on an atrial side of the native heart valve annulus (Fig 20);
a second anchoring feature (29a) extending from a distal end portion of the frame (Note: proximal is interpreted as atrial and distal as ventricle), wherein the second anchoring feature includes a plurality of distal anchors (29a) extending upwardly towards the proximal end portion of the frame upon deployment of the frame for capturing native leaflets of a native heart valve (Figs 16 & 20), the second anchoring feature being sized for placement on a ventricular side of the native heart valve annulus (Fig 20), wherein the distal anchors comprise looped ends (32a);
a plurality of elongate tips (shown) having enlarged ends (the junction of two smaller struts) for engagement with (contact the catheter in the compressed version as shown in Fig 20a) a delivery device (page 8: lines 7-10), the elongate tips extending from the proximal end portion of the frame and projecting inwardly toward a central axis of the frame upon deployment of the frame (Fig 16);
a plurality of elongate struts (36a) extending distally from the distal end portion of the frame; and
a valve body (Figs 9A & 9B) positioned within an interior of the frame, wherein the valve body comprises a plurality of leaflets (48) configured to allow blood to flow only from an atrium to a ventricle of the native heart valve.
Regarding Claim 9, Ma teaches wherein the prosthesis further comprises a liner extending along an interior of at least a portion of a length of the frame (page 8: line 25 – page 9: line 3 & page 10: lines 1-4).
Regarding Claim 10, Ma teaches wherein the liner is attached to the plurality of leaflets of the valve body (page 8: line 25 – page 9: line 3 & page 10: lines 1-4).
Regarding Claim 11, Ma teaches wherein the prosthesis further comprises a flap (interpreted as the fabric cover taught in page 8: line 25 – page 9: line 3 & page 10: lines 1-4) assembly positioned around and secured to a shoulder portion (shown) of the frame formed by the first anchoring feature.
Regarding Claim 12, Ma teaches wherein the shoulder portion (shown) includes a first bend (shown) extending radially outward from a central axis of the frame and second bend (shown) proximal of the first bend that extends in a direction generally parallel to the central axis of the frame.
Regarding Claim 14, Ma teaches wherein a number of the plurality of elongate struts (36a) corresponds to a number of commissures of the valve body (72, 74 & 76).
Regarding Claim 15, Ma teaches wherein the commissures of the valve body are secured to the elongate struts (page 20: lines 5-11).
Regarding Claim 16, Ma teaches wherein each of the elongate struts (36a) is formed with eyelets (shown).
Regarding Claim 18, Ma teaches the device entirely as set forth in the rejection of claim 8.
Regarding Claim 19, Ma teaches wherein the plurality of elongate tips (shown) extending from the proximal end portion of the frame are angled inwardly with respect to a central axis of the frame (Fig 16).
Regarding Claim 20, Ma teaches wherein ends of one or more of the distal anchors (29a) are not generally aligned axially with ends of other of the distal anchors when the frame is deployed in a radially-expanded configuration. The examiner notes that the distal anchors (29a) are not aligned axially as they are offset around the circumference of the device.
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (WO 2015/057407) in view of Chau et al. (US 2013/0190861).
Regarding Claim 13, as set forth supra, Ma discloses the invention substantially as claimed. However, Ma does not disclose wherein the looped ends of the anchors include a cushion.
Chau teaches heart valve prosthesis (Fig 5) in the same field of endeavor. Said prosthesis comprising ventricular anchors (126) covered in a cushion material (164, 166) to increase tissue ingrowth and decrease frictional properties of the anchor [0108].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cover the distal anchors (29a), as taught by Ma, with the cover/cushion material, as taught by Chau, in order to increase tissue ingrowth and decrease frictional properties of the anchor.
Allowable Subject Matter
Claims 1-7 are allowed.
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding Claim 1, the prior art of record, which is the most pertinent art found, fails to teach and/or fairly suggest the instant invention. As set forth in the rejection of claims 8 & 14-16 supra, Ma et al. (WO 2015/057407) discloses the invention substantially as claimed. However, the prior art either individually or in combination, does not teach or render obvious wherein one or more of the distal anchors extend further distally than other distal anchors.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
