DETAILED ACTION
The following is a non-final office action is response to communications received on 07/22/2024. Claims 1-16 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.
Claims 1-16 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 pairs" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 states “the outer portion being sized to surround the inner portion and configured to anchor the prosthesis, the outer portion including a plurality of first crowns positioned around a first end of the outer portion and a plurality of second crowns positioned inward of the plurality of first crowns”. It is unclear what is meant positioned inward. Are the second crowns positioned proximate to the first crowns? Or are the second crowns positioned radially inward of the first crowns? Appropriate correction is required.
Claim 9 recites the limitation "the points" in line 5. 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) 1-3 & 9-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miyashiro (US 10,702,378).
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Regarding Claim 1, as best understood (see 112 rejection supra), Miyashiro teaches a heart valve prosthesis (100) comprising:
a frame (Fig 8) including
an inner portion (110) configured to support a prosthetic valve component and
an outer portion (120) coupled to the inner portion, the outer portion being sized to surround the inner portion and configured to anchor the prosthesis (Fig 8), the outer portion including a plurality of first crowns (shown) positioned around a first end (shown) of the outer portion and a plurality of second crowns (shown) positioned inward of the plurality of first crowns; and
a skirt (164 of Fig 6A) disposed within and coupled to the outer portion, wherein an end segment (shown) of the skirt, disposed proximate (shown) to the first end of the outer portion, does not substantially extend past the plurality of second crowns of the outer portion (Fig 9A) so as to leave a substantially unobstructed blood flow passageway (shown) through each of the pair of adjoining crowns.
Regarding Claim 2, Miyashiro teaches wherein the outer portion (120) includes a plurality of Y-shaped struts (Fig 9B), each coupled to one of the plurality of first crowns (shown) and positioned proximate the first end (shown).
Regarding Claim 3, Miyashiro teaches wherein each of the Y-shaped struts includes a node (shown), a primary strut (shown) that extends between a respective first crown (shown) of the plurality of first crowns and the node, and a pair of secondary struts (124) branching, at the node, from the primary strut toward the second end of the outer portion (Fig 9A-9B).
Regarding Claim 4, Miyashiro teaches wherein the skirt (164) is coupled (directly or indirectly) to each Y-shaped strut (Fig 9B) and each second crown by a suture (Col 15: lines 45-48).
Regarding Claim 5, Miyashiro teaches wherein the skirt (164) is coupled (directly or indirectly) to the primary strut (shown) and each of the pair of secondary struts (124) of each Y-Shaped strut.
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Regarding Claims 6 & 14, Miyashiro teaches wherein a first line of stitches (900/902) couples (directly or indirectly) the skirt to a first portion of each Y-shaped strut and a second line of stitches (900/902) couples (directly or indirectly) the skirt to a second portion of each Y-shaped strut (Fig 24B).
Regarding Claim 9, as best understood (see 112 rejection supra), Miyashiro teaches a method for manufacturing a heart valve prosthesis (100) comprising:
attaching an inner skirt (162) to an inner portion (110);
attaching an outer skirt (164) to an outer portion (120),
coupling the inner portion to the outer portion, wherein a plurality of pairs of adjoining crowns (shown as first crowns) are defined at the points where the inner portion and the outer portion are coupled; and
wherein an end segment of the outer skirt (shown), disposed proximate to a first end of the outer portion, does not substantially extend past a plurality of second crowns (shown) of the outer portion (Fig 9A) as to leave a substantially unobstructed blood flow passageway (shown) through each pair of adjoining crowns.
Regarding Claim 10, Miyashiro teaches wherein the outer portion (120) has a stent-like structure (Fig 9A) with a second end opposite the first end (shown), the outer portion including a plurality of first crowns (shown), a plurality of second crowns (shown), and plurality of Y-shaped strut (Fig 9B) positioned at the first end.
Regarding Claim 11, Miyashiro teaches wherein each of the Y-shaped struts includes a node (shown), a primary strut (shown) is positioned between a respective first crown (shown) of the plurality of first crowns and the node, and a pair of secondary struts (124) branching, at the node, from the primary strut toward the second end of the outer portion (Figs 9A-9B).
Regarding Claim 12, Miyashiro teaches wherein the outer skirt (164) is coupled (directly or indirectly) to each Y-shaped struts and each second crown by a suture (Col 15: lines 45-48).
Regarding Claim 13, Miyashiro teaches wherein the outer skirt (164) is coupled (directly or indirectly) to the primary strut (shown) and each of the pair of secondary struts (124) of each Y-Shaped strut.
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) 7-8 & 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miyashiro (US 10,702,378) in view of Yohanan et al. (US 2013/0150956).
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Regarding Claims 7-8 & 15-16, as set forth supra, Miyashiro discloses the invention substantially as claimed. Further, Miyashiro teaches that the skirt is attached to the inner surface (Col 8: lines 22-23) of the outer portion (120). However, Miyashiro does not specifically disclose: (1) wherein each of the first line of stitches and the second line of stitches forms a repeating pattern of axial segments and circumferential segments, and (2) wherein the first line of stitches and the second line of stitches are completed with a single continuous suture.
Yohanan teaches a prosthetic heart valve (Fig 1) in the same field of endeavor. Said prosthetic heart valve comprising a skirt (16) attached to struts (34) via sutures/stitches (shown), wherein each of a first line of stitches (shown) and a second line of stitches (shown) forms a repeating pattern of axial segments and circumferential segments (Fig 1), and wherein the first line of stitches and the second line of stitches are completed with a single continuous suture (Fig 1). Said suture/stitches anchor the skirt to the frame of the prosthetic heart valve.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to anchor the skirt, as taught by Miyashiro, to the frame/struts, as taught by Miyashiro, to ensure the skirt doesn’t migrate or allow regurgitation past the device following implantation.
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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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
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