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 1, claims 1-5 and 7 in the reply filed on December 29, 2026 is acknowledged. Claims 6 and 8-14 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 7 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 7, which is dependent on claim 1, recites the limitation "the extended portion" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purpose this limitation has been interpreted as “an extended portion.”
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) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen et al. (US 2006/0259136, hereinafter “Nguyen”).
Referring to claim 1, Nguyen discloses a method of manufacturing a prosthetic heart valve (FIGS. 1A and 3A-4B; FIGS. 3A-3B and 4B are reproduced below), the method comprising: coupling a plurality of prosthetic leaflets 22 to each other, and coupling the plurality of prosthetic leaflets to a cuff 21, to form a valve assembly 14; and coupling the valve assembly 14 to a stent 12 to form the prosthetic heart valve 10; wherein the valve assembly is formed prior to the plurality of prosthetic leaflets being coupled to the stent and prior to the cuff being coupled to the stent (paras. [0050]-[0054]. Para. [0053]: “In FIG. 4A, flap 34 first is folded along line d. Flap 35 is folded along line e so that it lies atop flap 34, forming seam 42 comprising a triple thickness of the tissue. Flap 36 then is folded along line f. Adjoining leaflets 22 then are fastened together along adjacent seams 42, resulting in a leaflet assembly.” Para. [0054]: “Next, the leaflet assembly is attached to skirt 21 along the bottom edges of bodies 33 of the leaflets to form joints 44... Valve body 14 then is ready to be affixed to frame 12.”).
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Referring to claim 2, Nguyen discloses the method of claim 1, wherein upon forming the valve assembly 14, the valve assembly is in a flat condition (FIG. 4B).
Referring to claim 3, Nguyen discloses the method of claim 1, wherein the plurality of prosthetic leaflets each include a free edge 32, 33 (FIGS. 3A-3B and 4B; para. [0050]-[0051]), a scalloped edge 32, 33 (FIGS. 3A-3B and 4B), and tabs 30, 31 (FIGS. 3A-3B and 4B) between the free edge and the scalloped edge.
Referring to claim 4, Nguyen discloses the method of claim 3, wherein coupling the plurality of prosthetic leaflets 22 to the cuff 21 includes coupling a portion of the free edge of each of the plurality of prosthetic leaflets to an edge of the cuff at spaced apart locations along the edge of the cuff (FIG. 4B; para. [0054]).
Referring to claim 5, Nguyen discloses the method of claim 4, wherein forming the prosthetic heart valve 14 includes positioning the plurality of prosthetic leaflets 22 inside the stent 12, and wrapping the cuff around an inflow edge of the stent 12 so that the cuff is positioned outside the stent (FIG. 1A; paras. [0052] and [0055]. Para. [0052]: “End tabs 39 are folded over the ends of the proximal-most row of cells of frame 12 to secure skirt 21 to the frame and seal against perivalvular bypass flows (see FIG. 1A).”).
Referring to claim 7, Nguyen discloses the method of claim 1, wherein forming the valve assembly 14 includes coupling a terminal edge of the extended portion of the cuff to the stent at spaced apart locations along the terminal edge of the extended portion of the cuff after wrapping the extended portion of the cuff around the inflow edge of the stent (FIG. 4B; paras. [0052] and [0055]. Para. [0052]: “End tabs 39 are folded over the ends of the proximal-most row of cells of frame 12 to secure skirt 21 to the frame and seal against perivalvular bypass flows (see FIG. 1A).”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771