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 .
Allowable Subject Matter
Claims 6-11 are 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: The closest prior art is Quadri et al. (Pub. No.: US 2010/0082094) and Neethling et al. (Pub. No.: US 2019/0117390), however, neither fairly teaches or suggests creating folds in the flat sheet of the valve material in each of the two or more valve leaflet regions, prior to performing the step of cutting. Quadri discloses patterns which are flat and not folded prior to cutting. Neethling teaches molding a sheet of valve material prior to cutting, to provide a three-dimensional leaflet belly which may be broadly construed as a fold. However, Neethling does not fairly teach or suggest “creating folds” in each of the two or more valve leaflet regions, as, at best, Neethling would provide a single fold at point 1152.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, in the reply filed on 4/10/2026 is acknowledged.
Claims 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 Objections
Claim 7 is objected to because of the following informalities: Claim 7 depends from itself. Appropriate correction is required. For purposes of examination, claim 7 is treated as if it depends from claim 6.
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 1-5, 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quadri et al. (Pub. No.: US 2010/0082094)
Quadri et al. (hereinafter, Quadri) discloses a method of manufacturing a heart valve prosthesis for transcatheter delivery (abstract) comprising:
cutting a flat sheet of a valve material into a single-piece valve pattern 632 (para. 127) having two or more valve leaflet regions 654 and a valve skirt region 640 (e.g., fig. 18);
arranging the two or more valve leaflet regions of the single-piece valve pattern into a mold 840 for forming a leaflet belly for each of the two or more valve leaflet regions (e.g., para. 132-134, fig. 20-21);
fixing, while arranged in the mold, a shape of the leaflet belly of each of two or more valve leaflet regions of the single piece-valve pattern (e.g., para. 134);
creating a side seam by attaching two longitudinal edges of the single-piece valve pattern, to thereby form a tubular valve subassembly with two or more valve leaflets (e.g., para. 67); and
attaching the tubular valve subassembly within a tubular frame to form a heart valve prosthesis (e.g., abstract, fig. 17).
For claim 2, Quadri discloses the method of claim 1, wherein the single-piece valve pattern also includes an outer wrap region (e.g., para. 113).
For claim 3, Quadri discloses the method of claim 1, wherein cutting the flat sheet is performed with one or more of a laser or a cutting die (e.g., para. 64).
For claim 4, Quadri discloses the method of claim 1, the method further comprising: creating a commissure 660 on the tubular valve subassembly at each juncture between adjoining valve leaflets (e.g., fig. 18-19).
For claim 5, Quadri discloses the method of claim 1, the method further comprising: creating a margin of attachment for each of two or more valve leaflets of the tubular valve subassembly (e.g., fig. 18-19).
For claim 13, Quadir discloses the method of claim 1, wherein creating the side seam is performed by sewing a thread or suture to join the two longitudinal edges of the single-piece valve pattern (e.g., para. 67).
For claim 14, Quadri discloses the method of claim 1, wherein attaching the tubular valve subassembly within the tubular frame is performed by sewing the tubular valve subassembly to the tubular frame with a thread or suture (e.g., fig. 6A).
For claim 15, Quadri discloses the method of claim 1, wherein the valve material is one of bovine or porcine pericardial tissue, a heat setting, synthetic material, or combination thereof (e.g., para. 63).
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Quadri et al. (Pub. No.: US 2010/0082094) in view of Neethling et al. (Pub. No.: US 2019/0117390).
For claim 12, Quadri lacks a mold having a first and second part. Neethling teaches forming a valve from a single piece of tissue (abstract) including placing the sheet within a two-piece mold such that the tissue is sandwiched therebetween (para. 7) which allows the valve to be shaped and the tissue to be cross-linked while in the mold (para. 7). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified the method of Quadri such that the Quadri pattern is placed within a mold as taught by Neethling (e.g., fig. 11-12) for the purpose of cross-linking and shaping the valve leaflet within the mold. This modification would have yielded predictable results and would have occurred using known methods.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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