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 .
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.
Response to Amendment
The amendment filed 05/15/2026 has been entered. Claims 1-4, 8-9, 12-15, and 21 remain pending in the application. Claims 5-7, 10-11, and 16-20 have been cancelled. Claim 14 remains withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to claims 1, 9, and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 21 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.
The term “substantially ” in claim 21 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claims 1-4, 8, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190262129 A1 (hereafter –Cooper--).
Regarding Claim 1, Cooper discloses a prosthetic heart valve comprising: a collapsible and expandable outer frame configured to engage tissue of a native heart valve annulus (see paragraph [0103]), the outer frame having an atrial portion adapted to be positioned on an atrial side of the native heart valve annulus, a ventricle portion adapted to be positioned on a ventricle side of the native heart valve annulus (see paragraphs [0107] and [0108]), a narrowed waist portion between the atrial portion and the ventricle portion (see annotated narrowed waist portion in Figure 6A below) and a plurality of outer coupling arms having a first end coupled to the outer frame and a second free end (see annotated outer coupling arms having first and second ends in Figure 6A below), a collapsible and expandable inner frame positioned radially inward of the outer frame and configured for foreshortening upon expansion (see paragraph [0123]), the inner frame having a first row of closed, generally diamond-shaped cells at an inflow-most end of the inner frame, the inner frame including a plurality of inner coupling arms having a first end coupled to the first row of closed, generally diamond-shaped cells and a second free end (see annotated first and second ends of inner coupling arms in Figure 2 below), the plurality of inner coupling arms extending radially outward from the first row of closed generally diamond-shaped cells at the inflow-most end of the inner frame (see annotated inner coupling arms and first row of closed diamond shaped cells in Figure 2 below); and a prosthetic valve assembly coupled to, and positioned radially inward of, the inner frame (see Abstract); wherein the second free ends of the outer coupling arms are coupled to the second free ends of the inner coupling arms to couple the outer frame to the inner frame (see Figure 1 below, see also paragraph [0125]), wherein, in an expanded condition of the outer frame, the outer coupling arms are contoured so that the second free ends of the outer coupling arms are substantially parallel to a central longitudinal axis of the outer frame (see annotated eyelets 106 and 143 of inner and outer frames, which are parallel to the central axis of the frames, being the connection points of the two frames as denoted in paragraph [0125]), the central longitudinal axis of the outer frame extending from the inflow end of the outer frame to the outflow end of the outer frame (see annotated axis in Figure 1 below), wherein, in the expanded condition of the inner frame, the inner coupling arms are contoured so that the second free ends of the inner coupling arms are substantially parallel to a central longitudinal axis of the inner frame (see annotated coupling arms in Figure 2 below), the central longitudinal axis of the inner frame extending from an inflow end of the inner frame to an outflow end of the inner frame (see annotated axis in Figure 1 below).
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Regarding Claim 2, Cooper discloses the prosthetic heart valve of claim 1, wherein the outer coupling arms are integral with the outer frame, and the inner coupling arms are integral with the inner frame (see annotated outer and inner coupling arms and inner and outer frames in Figures 1, 2, and 6A above).
Regarding Claim 3, Cooper discloses the prosthetic heart valve of claim 1, wherein the second free ends of the outer coupling arms are coupled to the second free ends of the inner coupling arms via mechanical fasteners (see paragraph [0125]).
Regarding Claim 4, Cooper discloses the prosthetic heart valve of claim 3, wherein the mechanical fasteners are sutures (see paragraph [0125]).
Regarding Claim 8, Cooper discloses the prosthetic heart valve of claim 1, wherein in a collapsed condition of the inner frame, each inner coupling arm is positioned within one of the cells in the first row of cells at the inflow end of the inner frame (see paragraph [0116] denoting that the inner frame is flexible, and therefore would be capable of having in a collapsed condition of the inner frame, each inner coupling arm is positioned within one of the cells in the first row of cells at the inflow end of the inner frame).
Regarding Claim 21, Cooper discloses the prosthetic heart valve of claim 1, wherein the first ends of the outer coupling arms coupled to the outer frame at a location substantially equidistant between an inflow end of the outer frame and an outflow end of the outer frame (see annotated first ends in Figure 6A above). The Examiner would like to note that inflow “end” and outflow “end” can be any portion of the stent, since “end” is such a broad term. Additionally, the term “substantially” leaves room for a broader interpretation for “equidistant.
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.
Claims 9, 12-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190262129 A1 (hereafter –Cooper--), in view of US 20180125649 A1 (hereafter --Nasr--).
Regarding Claim 9, Cooper discloses a prosthetic heart valve comprising: a collapsible and expandable outer frame configured to engage tissue of a native heart valve annulus (see paragraph [0103]), the outer frame having an atrial portion adapted to be positioned on an atrial side of the native heart valve annulus, a ventricle portion adapted to be positioned on a ventricle side of the native heart valve annulus (see paragraphs [0107] and [0108]), a narrowed waist portion between the atrial portion and the ventricle portion (see annotated narrowed waist portion in Figure 6A below), and a plurality of outer coupling arms having a first end coupled to the narrowed waist portion and a second free end (see annotated first and second ends in Figure 6A below); a collapsible and expandable inner frame positioned radially inward of the outer frame and configured for foreshortening upon expansion (see paragraph [0123], see Figure 1 below), the inner frame having a first row of closed, generally diamond shaped cells at an inflow end of the inner frame, and a second row of closed, generally diamond shaped cells positioned in an outflow direction relative to the first row of generally diamond shaped cells, the inner frame including a plurality of inner coupling arms having a first end coupled to the first row of closed, generally diamond-shaped cells and a second free end (see annotated first and second rows of diamond shaped cells, as well as the inner coupling arms in Figure 2 below), the second free ends of the outer coupling arms being coupled to the second free ends of the inner coupling arms to couple the outer frame to the inner frame (see paragraph [0125]); and a prosthetic valve assembly coupled to, and positioned radially inward of, the inner frame (see Abstract); wherein the inner frame includes a plurality of axial struts extending from the second row of generally diamond shaped cells in a direction away from the inflow end of the inner frame (see annotated axial strut in Figure 2 below), a plurality of support struts coupling the axial struts to the second row of generally diamond shaped cells, wherein each axial strut is coupled to the second row of generally diamond shaped cells by a pair of supports struts of the plurality of support struts (see annotated axial struts and support struts in Figure 2 below), wherein each support strut in the pair of support struts has a first end coupled to a terminal end of the axial strut, and a second end coupled to the second row of generally diamond shaped cells (see annotated second row of generally diamond shaped cells and terminal end of axial strut in Figure 2 below).
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Cooper fails to disclose the axial struts defining commissure windows, prosthetic leaflets of the prosthetic valve assembly being coupled to the axial struts via the commissure windows.
Nasr discloses a prosthetic valve for implantation into a patient (see Abstract) with an inflow end, outflow end, first row of cells, second row of cells, support struts, and axial struts (see annotated Figure 5 below). Nasr teaches the axial struts defining commissure windows, prosthetic leaflets of the prosthetic valve assembly being coupled to the axial struts via the commissure windows (see annotated commissure windows in Figure 5 below, see also paragraphs [0043] denoting second ends 69 may form a commissural attachment area for attachment to valve leaflets 45, and [0044] denoting second ends 69 of beams 60 may be connected to one or more retaining components 78, the leaflets being capable of being connected to axial struts through said retaining components).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, for the axial struts of Cooper to define commissure windows at the outflow end of the inner frame as taught by Nasr, and for the prosthetic leaflets of the prosthetic valve assembly being coupled to the axial struts via the commissure windows, as the substitution of one known element (end of axial strut of Cooper) for another (end of axial strut defining a commissure window of Nasr) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the end of the axial strut of Copper would have yielded predictable results, namely, the same axial strut of Cooper but with a commissure window at the outflow end of the axial strut as shown in Nasr to support the formation of a commissural attachment area for attachment to valve leaflets and as the window may aid in anchoring the valve within a patient (see paragraphs [0044] and [0045]).
Regarding Claim 12, Cooper as modified by Nir discloses the prosthetic heart valve of claim 9, wherein each support strut in the pair of support struts extends from the axial strut in opposite circumferential directions (see support struts in Figure 2 above).
Regarding Claim 13, Cooper as modified by Nir discloses the prosthetic heart valve of claim 9, wherein the pair of the support struts and the axial strut together present a blunted atraumatic surface (see annotated blunted atraumatic surface in Figure 2 above).
Regarding Claim 15, Cooper discloses a prosthetic heart valve comprising: a collapsible and expandable outer frame configured to engage tissue of a native heart valve annulus (see paragraph [0103]), the outer frame having an atrial portion adapted to be positioned on an atrial side of the native heart valve annulus, a ventricle portion adapted to be positioned on a ventricle side of the native heart valve annulus (see paragraphs [0107] and [0108]), a narrowed waist portion between the atrial portion and the ventricle portion (see annotated narrowed waist portion in Figure 6A below), and a plurality of outer coupling arms having a first end coupled to the narrowed waist portion and a second free end (see annotated outer coupling arms and first end and second free ends in Figure 6A); a collapsible and expandable inner frame positioned radially inward of the outer frame and configured for foreshortening upon expansion (see paragraph [0123], see annotated inner frame in Figure 2 below), the inner frame having a first row of closed, generally diamond shaped cells at an inflow end of the inner frame (see annotated a first row of closed, generally diamond shaped cells in Figure 2 below), and a second row of closed, generally diamond shaped cells positioned in an outflow direction relative to the first row of generally diamond shaped cells (see annotated a second row of closed, generally diamond shaped cells in Figure 2 below), the inner frame including a plurality of inner coupling arms having a first end coupled to the first row of closed, generally diamond-shaped cells and a second free end (see annotated first and second ends of inner coupling arms in Figure 2 below), the second free ends of the outer coupling arms being coupled to the second free ends of the inner coupling arms to couple the outer frame to the inner frame (see also paragraph [0125]); and a prosthetic valve assembly coupled to, and positioned radially inward of, the inner frame (see Abstract); wherein the inner frame includes a plurality of axial struts extending from the second row of generally diamond shaped cells in a direction away from the inflow end of the inner frame (see annotated axial struts in Figure 2 below), a plurality of support struts coupling the axial struts to the second row of generally diamond shaped cells (see annotated support struts in Figure 2 below), wherein each axial strut is coupled to the second row of generally diamond shaped cells at an outflow apex of a cell in the second row of generally diamond shaped cells (see annotated outflow apex in Figure 2 below).
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Cooper fails to disclose the axial struts defining commissure windows, prosthetic leaflets of the prosthetic valve assembly being coupled to the axial struts via the commissure windows.
Nasr discloses a prosthetic valve for implantation into a patient (see Abstract) with an inflow end, outflow end, first row of cells, second row of cells, support struts, and axial struts (see annotated Figure 5 below). Nasr teaches the axial struts defining commissure windows, prosthetic leaflets of the prosthetic valve assembly being coupled to the axial struts via the commissure windows (see annotated commissure windows in Figure 5 below, see also paragraphs [0043] denoting second ends 69 may form a commissural attachment area for attachment to valve leaflets 45, and [0044] denoting second ends 69 of beams 60 may be connected to one or more retaining components 78, the leaflets being capable of being connected to axial struts through said retaining components).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, for the axial struts of Cooper to define commissure windows at the outflow end of the inner frame as taught by Nasr, and for the prosthetic leaflets of the prosthetic valve assembly being coupled to the axial struts via the commissure windows, as the substitution of one known element (end of axial strut of Cooper) for another (end of axial strut defining a commissure window of Nasr) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the end of the axial strut of Copper would have yielded predictable results, namely, the same axial strut of Cooper but with a commissure window at the outflow end of the axial strut as shown in Nasr to support the formation of a commissural attachment area for attachment to valve leaflets and as the window may aid in anchoring the valve within a patient (see paragraphs [0044] and [0045]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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