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
Claims 1-10 and 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/20/26.
The Applicant’s representative discloses that claim 17 reads on the elected Species III. However, the Examiner has withdrawn claim 17, since, claim 17 is referring to the embodiment of Figure 20 disclosing a main body extending longitudinally and distally along the inner surface. For the reasons above the Examiner has withdrawn the claim.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 11 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen et al US Patent Pub. 2006/0259136 A1.
Nguyen et al discloses valve prosthesis (10) comprising a stent structure (12), a one-piece (see Fig. 4B) molded valve (see paragraph 23 saying that it can be stitched or molded) coupled to the stent structure, the one-piece molded valve comprising commissures (where elements g, h and I are located, see Fig. 3B), commissure tabs (36, see Fig. 4B) extending from the commissures. Each commissure tab comprising a main body (34 and 35, see Fig. 4A), a first ear (36) attached to the main body; and a second ear (36) attached to the main body. See Figs. 3A-4B.
Claim Rejections - 35 USC § 103
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 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 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Biadillah et al US Patent Pub. 2014/0018915A1 in view of Nguyen et al US Patent Pub. 2006/0259136A1.
Biadillah et al discloses a valve prosthesis comprising a stent structure, a one-piece valve coupled to the stent structure, the one-piece molded valve comprising commissures, commissure tabs extending from the commissures. Each commissure tab comprising a main body, a first ear attached to the main body and a second ear attached to the main body. The valve is made of stitching the leaflets to the skirt. However, Biadillah et al does not disclose a single piece molded valve.
Nguyen et al teaches all the limitations of claim 11 as disclosed in the 102 rejection above. Especially, teaches leaflets and a skirt attached together by stitches or molded and efficiently distribute forces along the leaflets and to the frame (see paragraph 23).
It would have been obvious to one ordinary skill in the art to modify the stitches valve of the Biadillah et al with the molded valve of the Nguyen et al reference in order to have a strong connection between the skirt and the leaflets and efficiently distribute forces along the leaflets and to the frame.
Regarding claim 12, see paragraph 111, lines 26-31, the Examiner interpreted that the main body is the section of the tabs (30) passing through the slit (8) of the pericardium tissue (4). See also Fig. 5c.
Regarding claims 13 and 14, see Figs. 5d and 5e, see paragraph 111, lines 35 to the end of the paragraph.
Regarding claim 15, the first and second ears extend perpendicular from the main body when the tabs (30) fold and cover element 22a, see especially the two embodiments in Figs. 4a and 4d.
Regarding claim 16, see Figs. 5d and 5e showing the commissure tab wrapping around and attached to the post.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 5/5/26
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