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 .
Election/Restrictions
Applicant’s election without traverse of Group I and Species D in the reply filed on 10/23/2025 is acknowledged. Claims 8-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups and species, there being no allowable generic or linking claim. Claim 7 has further been withdrawn as being directed towards a nonelected species embodiment. Election was made without traverse in the reply filed on 10/23/2025. The requirement is deemed proper and is therefore made FINAL.
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 4, 5, 18, and their dependent claims 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 states that the suture loops are formed by the end portion extensions of the sutures. Claims 4 and 5 state that the end portion extensions of the sutures are coupled along the loops. It is unclear how the end portion extensions are structured to both form the loops and be coupled to one another along the loops that the extensions are forming. This issue is also present in claims 17 and 18. Appropriate correction and/or clarification is required.
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.
Claim(s) 1-6 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levi et al. (Pub. No.: US 2012/0123529 A1; hereinafter “Levi”).
Levi discloses the following regarding claim 1: a method of assembling a prosthetic heart valve comprising a plurality of leaflets (paras. 0009-0010), the method comprising: forming a plurality of commissures (e.g., 376) with the plurality of leaflets (e.g., 314) (e.g., Figs. 60-71), wherein each commissure is formed by: pairing a first commissure tab (e.g., left side element 366 as shown in Fig. 64) of a first leaflet with an adjacent, second commissure tab (e.g., right side element 366 as shown in Fig. 64) of a second leaflet, and coupling a support strip (e.g., 378) to the first and second commissure tabs via sutures (e.g., 390) extending through apertures (e.g., openings that elements 390 pass through) of suture lines (Figs. 61-62) that are disposed on opposing sides (e.g., left and right sides of element 378, as shown in Fig. 62) of the support strip, the sutures forming stitches along the support strip (Fig. 62); and for each commissure, securing the commissure to a respective support of a frame by forming one or more suture loops (e.g., curved portions of element 390) around an external surface of the support strip and the respective support of the frame (e.g., Figs. 61-71; paras. 0102-0104), wherein the one or more suture loops are formed by end portion extensions (e.g., left and right side end lengths of the sutures that form the curved portions) of the sutures (e.g., Figs. 62, 64).
Levi discloses the following regarding claim 2: the method of claim 1, wherein the sutures are secondary sutures (Fig. 62) and the suture lines are secondary suture lines (Fig. 62), and wherein each commissure is further formed by further coupling the support strip to the first and second commissure tabs via a primary suture (392) extending through apertures (openings that element 392 extends through) of primary suture lines of the support strip (Fig. 62), the primary suture lines being spaced from the secondary suture lines (Fig. 62; paras. 0102-0104).
Levi discloses the following regarding claim 3: the method of claim 1, wherein the sutures are secondary sutures (Fig. 62) and the suture lines are secondary suture lines (Fig. 62), and wherein, for each commissure, securing the commissure to the respective support of the frame further comprises extending an additional, tertiary suture (392) through apertures (openings that element 392 extends through) of tertiary suture lines (Fig. 62) on opposing sides of the support strip and across the respective support of the frame (Fig. 62).
As best interpreted, Levi discloses the following regarding claim 4: the method of claim 1, wherein, for each commissure, the end portion extensions extend from a first side (posterior side) of the support strip, across a surface of the respective support of the frame (Figs. 63-64), to a second side (anterior side) of the support strip, and wherein the end portion extensions of the sutures are coupled to one another along a selected loop of the one or more suture loops (Figs. 61-64), thereby forming a coupling (portion of element 390 that joins the loops to one another) that is disposed along the selected loop (Figs. 61-64).
As best interpreted, Levi discloses the following regarding claim 5: the method of claim 4, wherein the end portion extensions of the sutures couple to one another along a plurality of selected loops of the one or more suture loops (Figs. 61-64), thereby forming a plurality of couplings (portions of elements 390 that join the loops to one another) that are respectively disposed along each of the plurality of selected loops (Figs. 61-64).
Levi discloses the following regarding claim 6: the method of claim 1, wherein the apertures of the suture lines are positioned at a first region (upper interior region) of an interior side of the support of the frame (Figs. 62-64), and wherein the one or more suture loops extend from a first region of the interior side of the support, around a first lateral side (posterior lateral side) of the support, across an external side (central side) of the support, around a second lateral side (anterior lateral side) of the support, and to a second region (lower interior region) of the interior side of the support (Figs. 61-64), wherein the interior side of the support is opposite of the external side of the support (Figs. 61-64) and the first and second lateral sides of the support are opposite of one another and extend between the interior side of the support and the external side of the support (Fig. 64).
Levi discloses the following regarding claim 17: a method of assembling a prosthetic heart valve comprising a plurality of leaflets (paras. 0009-0010), the method comprising: forming a plurality of commissures (e.g., 122) with the plurality of leaflets (e.g., 40), wherein each commissure is formed by: pairing a first commissure tab (e.g., left side elements 112, 116) of a first leaflet with an adjacent, second commissure tab (e.g., right side elements 112, 116) of a second leaflet (Fig. 29), coupling a support strip (e.g., 124) to the first and second commissure tabs via primary sutures (e.g., 146) extending through the support strip and the first and second commissure tabs to form stitches along primary suture lines of the support strip (Fig. 29; paras. 0080-0082), and coupling end portions of the support strip to the first and second commissure tabs, respectively, via secondary sutures (e.g., 150) extending through the support strip and the first and second commissure tabs, respectively, to form stitches along respective secondary suture lines of the support strip (Fig. 29; paras. 0081-0082); and for each commissure, securing the commissure to a respective commissure support portion (e.g., 30) of an annular frame (e.g., 12) of the prosthetic heart valve by one or more suture loops (e.g., curved portions of element 150) that are formed by end portion extensions (e.g., left and right side end lengths of the sutures that form the curved portions) of the secondary sutures that extend around an external surface of the support strip and the respective commissure support portion of the annular frame (Fig. 29).
As best interpreted, Levi discloses the following regarding claim 18: the method of claim 17, further comprising, for at least one suture loop of the one or more suture loops, coupling together the end portion extensions of the sutures along the suture loop (via portions of elements 150 that join the loops to one another) (Figs. 29-30).
Levi discloses the following regarding claim 19: the method of claim 17, wherein the end portion extensions of the suture are respectively extended through apertures (openings for elements 150) of the secondary suture lines of the support strip (Figs. 29-30).
Levi discloses the following regarding claim 20: the method of claim 17, wherein, for each commissure, securing the commissure to the respective support of the frame further comprises extending an additional, tertiary suture (e.g., 148) through apertures (openings housing elements 148) of tertiary suture lines on opposing sides of the support strip and across the respective commissure support portion of the frame (Fig. 29; paras. 0081-0082).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774